0A4F4F9BD490A749D5437F821CF06DF1
Austrian Medical Devices Law, Article 47 (2017)
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10011003&ShowPrintPreview=True
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| Indicators in focus are typically shown highlighted in yellow; |
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"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
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p.(None): Diagnostic agents are intended for the application for which it is intended.
p.(None): (5c) "Medical device with a derivative from human blood" is a medical device according to the
p.(None): Directive 90/385 / EEC or Directive 93/42 / EEC, which contains a substance as a component, which - separately
p.(None): used - as a drug component or drug from human blood or blood plasma in the sense
p.(None): of Art. 1 Point 10 of Directive 2001/83 / EC and in addition to the medical device
p.(None): can have an effect on the human body. The aforementioned shock is referred to below as “derivative
p.(None): from human blood ”.
p.(None): (6) "Custom-made products" are all medical devices, with the exception of in vitro diagnostic medical devices, which according to
p.(None): written prescription from a doctor or another legally based on their professional qualifications
p.(None): authorized person, under their responsibility, specially made according to speci fi c design criteria
p.(None): and are intended for exclusive use in a named patient.
p.(None): Standard medical devices that have to be adapted to the speci fi c
p.(None): To meet the requirements of the doctor or any other licensed user authorized to do so,
p.(None): are not considered to be custom-made.
p.(None): (7) "Manufacturer" is any natural or legal person responsible for the design, manufacture, packaging
p.(None): and labeling a medical device with a view to placing it on the market for the first time
p.(None): Name is responsible. This applies regardless of whether these activities are carried out by this person or
p.(None): Company or acting on behalf of a third party.
p.(None): (8) A manufacturer is also any natural or legal person who has one or more prefabricated ones
p.(None): Assembled, packaged, treated, prepared or labeled products or for determining the products
p.(None): Intended use as a medical device with regard to the placing on the market in your own name
p.(None): is. However, a manufacturer is not someone who has already been placed on the market without being a manufacturer within the meaning of paragraph 7
p.(None): Assembled products for a named patient according to their intended use
p.(None): adapts.
p.(None): (8a) "Authorized Representative" is the natural or established in the European Economic Area (EEA)
p.(None): legal person who has been expressly designated by the manufacturer with regard to his from this
p.(None): Federal law obligations to act on his behalf and those of the authorities and
p.(None): To be contacted in this sense in the EEA. Has a manufacturer in its own name
p.(None): Medical device, does not have a seat in a contracting party to the EEA, it must be in writing for
p.(None): at least all medical devices of the same model have a single authorized representative in
p.(None): Name EEA.
p.(None): (9) "Intended use" is the use for which the medical device is designed according to the information provided by the
p.(None): Manufacturer in the label, the instructions for use or the advertising material.
p.(None): (10) "Placing on the market" is the return of a medical device, whether for a fee or free of charge, or that
p.(None): Have it ready for delivery. A placing on the market does not exist if
p.(None): 1. it is a medical device exclusively intended for clinical testing within the meaning of § 3
p.(None): Paragraph 3 or an in vitro diagnostic medical device for performance evaluation purposes within the meaning of Section 3 Paragraph 3a
p.(None): These,
p.(None): 2. it is ensured by means of suitable measures that the medical device does not reach the consumer,
p.(None): Can reach users or operators, or
p.(None): 3. individual medical devices to a single specific person exclusively free of charge and in
p.(None): private area or neighborhood help.
p.(None): (11) "Placing on the market for the first time" is the first placing on the market of a medical device or the first
p.(None): Placing a medical device on the market after its reprocessing with a view to its distribution or
p.(None): its use within the scope of the Agreement on the European Economic Area.
p.(None): (12) "Responsible for the first placing on the market in the European Economic Area"
p.(None): 1. the manufacturer,
p.(None): 2. his representative or
p.(None): 3. the importer,
p.(None): which is a medical device for the first time within the scope of the Agreement on the European
p.(None): Puts the economic area on the market and within the scope of the Agreement on the European
p.(None): Economic area is established.
p.(None): (13) “Commissioning” is the phase in which a medical device is used by the end user as an article
p.(None): Is made available for the first time as a ready-to-use medical device according to its
p.(None): Purpose in the scope of the European Economic Area can be used. at
p.(None): active implantable medical devices is considered to be the commissioning provided by the
p.(None): medical personnel for implantation.
p.(None): (14) "Exhibiting" is the setting up or demonstration of medical devices for the purpose of advertising or
p.(None): the information of the specialist circles.
p.(None): (15) "Harmonized standards" are national standards of the contracting states to the Agreement on the
p.(None): European Economic Area implementing relevant harmonized European standards, their
p.(None): Locations as "harmonized standards" for medical devices in the Official Journal of the European Communities
p.(None): have been published. The harmonized standards are relevant monographs of the European
p.(None): Pharmacopoeia for medical devices, their sources in the Official Journal of the European
p.(None): Communities have been released. The harmonized standards are also common
p.(None): Technical speci fi cations that are in accordance with Article 7 (2) of Directive 98/79 / EC of the European Parliament
p.(None): and the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331 of 7 December 1998)
p.(None): adopted and published in the Official Journal of the European Communities. In these
p.(None): Speci fi cations are used in a suitable manner to define the criteria for the evaluation and re-evaluation of the
p.(None): Performance, the batch release criteria, the reference methods and the reference materials.
p.(None): (16) "Notified Body" is one of a Contracting Party to the Agreement on the European
p.(None): Economic area of the European Commission and the other contracting parties for the
p.(None): Execution of tasks in the context of conformity assessment procedures for medical devices
p.(None): notified body.
p.(None): (17) “Side effects” are those when the medical device is used as intended
p.(None): occurring and related undesirable side effects.
p.(None): (18) "Mutual influence" means those that occur when used as intended
p.(None): Effects of
p.(None): 1. Medical devices on top of each other or
p.(None): 2. Medical devices and other objects, substances or preparations made of substances on top of each other.
p.(None): (19) "Maintenance" of a medical device is the entirety of the measures for preservation and
p.(None): Restoration of the desired target state and for the determination and assessment of the
p.(None): Current state of a medical device. The term "maintenance" includes inspection, maintenance and
p.(None): Repair.
p.(None): (20) "Inspection" of a medical device is the entirety of all measures to determine and
p.(None): Assessment of the current status.
p.(None): (21) "Maintenance" of a medical device is the entirety of all measures for the preservation of the
p.(None): desired target state, the flawless safety and functionality of the medical device
p.(None): guaranteed.
p.(None): (22) "Repair" of a medical device are the measures to restore the
p.(None): specified target state, the flawless safety and functionality of the medical device
p.(None): guaranteed.
p.(None): (23) 'Healthcare institution' means any institution, post or institution in which
p.(None): Medical devices used by healthcare professionals or authorized professionals
p.(None): operated or applied, including those of the Federal Army that the
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p.(None): to investigate the safety and performance of the in vitro diagnostic medical device.
p.(None): (2b) "Clinical data" is safety or performance information that results from the use of a
p.(None): Medical device and come from the following sources:
p.(None): 1. clinical trials of the medical device in question, or
p.(None): 2. clinical trials or other studies reproduced in the scientific literature
p.(None): about a similar medical device, its similarity to the medical device in question
p.(None): can be demonstrated, or
p.(None): 3. Published or unpublished reports of other clinical experience with either
p.(None): the relevant medical device or a similar medical device, the similarity with
p.(None): the medical device in question can be proven.
p.(None): (3) "Medical device intended for clinical trials" is any medical device that is intended to
p.(None): a physician qualified in the respective field to conduct clinical trials
p.(None): Medical product on humans according to paragraph 2 in one of the intended medical
p.(None): Appropriate medical environment to be made available.
p.(None): (3a) "In vitro diagnostic medical device for performance evaluation purposes" is any in vitro diagnostic medical device that is dated
p.(None): Manufacturer is destined to pass one or more performance assessment tests in medical laboratories
p.(None): Analyzes or in another appropriate environment outside of the company's premises
p.(None): to become.
p.(None): (4) "Clinical investigator" is the doctor or dentist who is responsible for carrying out the clinical trial and
p.(None): is responsible in particular for the well-being of the candidate.
p.(None): (5) "Sponsor" is any natural or legal person who is responsible for planning the
p.(None): Initiation, implementation and funding of a clinical trial takes over. The sponsor must be in
p.(None): a contracting party to the EEA. The clinical investigator has the duties and the
p.(None): Sponsor to assume additional responsibility if he / she is conducting a clinical trial independently of
p.(None): Manufacturer of the medical device and carried out under their own responsibility.
p.(None): (6) "Monitor" is a person designated by the sponsor who is responsible for monitoring and
p.(None): reporting on the progress of the clinical trial is responsible.
p.(None): (7) “Clinical trial plan” or “Protocol” is a document that provides detailed information on the reasons,
p.(None): Intentions, goals, execution as well as planned analyzes, methodology and implementation of the clinical
p.(None): Exam contains.
p.(None): (7a) "Evaluation Plan" is a document that provides detailed information about a planned
p.(None): Performance evaluation test, especially with regard to the scientific, technical and
p.(None): medical justification, the objectives, the methodology, the intended analyzes and sampling, the
p.(None): testing performance criteria and requirements as well as the type and scope of the intended evaluation
p.(None): contains.
p.(None): (8) "Examiner" is either a patient or a healthy subject participating in a clinical
p.(None): Test or takes part in a performance evaluation test of an in vitro diagnostic medical device.
p.(None): (9) “Ethics Committee” is an independent body composed according to Section 58 (4)
p.(None): medical experts and other members whose job it is to assess whether a
p.(None): there is a scientifically adequately substantiated clinical trial and whether the safety of that
p.(None): Wellbeing, the rights and integrity of test takers are protected.
p.(None): (10) "Clinical Trial Final Report" or "Final Report" is a complete description and
...
p.(None): Representatives have such a right to vote only if the persons they represent are prevented.
p.(None): (8) The work of the delimitation and classification advisory board is carried out by the Federal Minister for
p.(None): Health led by rules of procedure.
p.(None): (9) The activity in the delimitation and classification advisory board is voluntary, without prejudice to paragraph 10.
p.(None): Any travel expenses are the members of the delimitation and classification advisory board, their deputies
p.(None): and consulted experts according to the highest fee level of the travel fee regulation 1955, BGBl.
p.(None): No. 133 to replace on request.
p.(None): (10) The members of the delimitation and classification advisory board, which are appointed by the Federal Office for
p.(None): Health care was entrusted with the preparation of relevant expert reports
p.(None): adequate compensation in terms of effort and time, which the
p.(None): Applicant has to bear.
p.(None): II. MAIN PIECE
p.(None): Section 1
p.(None): Medical device requirements
p.(None): Requirements for placing on the market and commissioning
p.(None): § 6. It is forbidden to place medical devices on the market, to set them up, to install them, to put them into operation
p.(None): take or apply if
p.(None): 1. there is reasonable suspicion that they meet the basic requirements within the meaning of sections 8 and 9
p.(None): and a regulation according to § 10 or, if applicable, does not meet the requirements of § 11 or
p.(None): 2. their expiry date has passed.
p.(None): Section 7. (1) Medical devices may only be placed on the market and in facilities in accordance with Section 112
p.(None): of the healthcare system can be put into operation if the for the first placing on the market
p.(None): Responsible for its seat in a party to the Agreement on the European Economic Area
p.(None): Has.
p.(None): (2) The provisions of section 6 (2) and (1) do not apply to the armed forces when deployed in accordance with section 2
p.(None): Paragraph 1 lit. a of the Wehrgesetzes 2001, BGBl. I № 146, as well as in the immediate preparation of this
p.(None): Insert.
p.(None): basic requirements
p.(None): § 8. (1) Medical devices must be designed and manufactured in such a way that their use does not comply with the
p.(None): clinical condition or patient safety still endangers the safety of users or third parties,
p.(None): if they are used under the intended conditions and for the intended purposes.
p.(None): Any risks and side effects that may result from proper installation, implantation or
p.(None): Application may need to be considered taking into account the effectiveness of the medical devices
p.(None): be defensible to the state of the medical sciences and technology and the protection of health
p.(None): and security must be guaranteed.
p.(None): (2) Medical devices must be designed, manufactured and packaged in such a way that they are suitable for use by
p.(None): Manufacturer to provide specified medical services in accordance with § 2 paragraph 1 or 5 if they
p.(None): Are exposed to loads under normal conditions of use and under those of the manufacturer
p.(None): provided transportation and storage conditions may occur.
p.(None): (3) The design and construction of medical devices must take into account the
p.(None): generally recognized state of science and technology according to the principles of integrated
p.(None): Straighten security. When choosing the most appropriate solutions for design and construction are in the
p.(None): apply the following principles in the order specified:
...
p.(None): Risks is required through regulation conformity assessment procedures for medical devices for the
p.(None): Prescribe vitro diagnosis as a prerequisite for placing on the market and commissioning and their
p.(None): Specify the content and implementation in more detail.
p.(None): Section 29. (1) Sets the conformity assessment procedure in accordance with an ordinance pursuant to Section 28 (1) or
p.(None): the procedure according to §§ 33 to 35 the participation of a notified body in advance, the
p.(None): Manufacturer or his authorized representative to a body of his choice designated for the fulfillment of these tasks
p.(None): turn. The simultaneous referral of several notified bodies within one
p.(None): Conformity assessment procedure for a medical device by the manufacturer or his authorized representative
p.(None): is not permitted.
p.(None): (2) In the conformity assessment procedure for a medical device, the manufacturer or the
p.(None): Notified body to take into account the results of assessments and tests that may be included in
p.(None): an intermediate stage of manufacture according to this federal law or other Austrian
p.(None): Regulations within the meaning of Section 112 (1) and (2) have been made.
p.(None): (3) The notified body is at its reasonable request all information or information
p.(None): to be submitted or made available for issuing the certificate of conformity and
p.(None): Maintenance of the conformity decision with regard to the chosen procedure are required.
p.(None): (4) The documents and correspondence regarding the procedures for conformity assessment are
p.(None): if they are carried out within the scope of this federal law, in German
p.(None): or in another official language of a contracting party to the Agreement on the European
p.(None): Economic area recognized by the notified body.
p.(None): (Note: Paragraphs 5 to 7 repealed by Federal Law Gazette I No. 119/2003)
p.(None): custom made
p.(None): § 30. (1) For each custom-made product, the manufacturer or his in the European Economic Area
p.(None): authorized representative before placing on the market for the first time in a regulation pursuant to § 28
p.(None): issue the intended declaration and make the documentation listed there available. From the
p.(None): Documentation must include the design, manufacture and performance data of the medical device
p.(None): including the intended performance, in such a way that it enables an assessment of whether
p.(None): has met the requirements of this federal law.
p.(None): (2) The manufacturer must take all necessary measures to ensure that the
p.(None): Compliance of the manufactured medical devices with the documentation according to a regulation
p.(None): § 28 is ensured. He has an assessment of the effectiveness of these measures or, if necessary, one
p.(None): Allow formal review (audit).
p.(None): (3) The Federal Office for Safety in Health Care can report all of the manufacturer
p.(None): Require custom-made products in accordance with Directive 93/42 / EEC, within the scope of this
p.(None): Federal law have been put into operation or placed on the market.
p.(None): Section 5
p.(None): Exhibit; Exemptions in the interest of health protection; Systems and
p.(None): Treatment units; Sterilization for placing on the market
p.(None): Exhibit
p.(None): Section 31. (1) Medical devices that do not comply with sections 15 and 27 may then
p.(None): Demonstration purposes, especially at trade fairs, exhibitions, demonstrations and scientific
p.(None): or medical technology events are issued if there is a visible sign on it
...
p.(None): The notification requirements according to § 70 remain unaffected.
p.(None): Suspension or prohibition of the clinical trial
p.(None): Section 40b. (1) Provided the Federal Office for Safety in Health Care has objective reasons for acceptance
p.(None): has that the requirements of the notification according to § 40 paragraphs 2 and 3 are no longer met, or about
p.(None): Information that is relevant to the safety or the scientific basis of a
p.(None): If the clinical trial raises concerns, it must suspend or prohibit the clinical trial.
p.(None): Before the decision, except in the event of imminent danger (§ 57 AVG), the sponsor and the
p.(None): to inform clinical investigators. The sponsor must give his opinion within one week.
p.(None): (2) The Federal Office for Safety in Health Care, provided that it carries out a clinical
p.(None): Suspends or prohibits review, the other EEA Contracting Parties, the relevant ethics committee,
p.(None): and the European Commission stating the reasons for its decision to conduct the clinical trial
p.(None): suspend or prohibit, inform. Has the Federal Office for Safety in Health Care
p.(None): ordered a significant change in a clinical trial, it has the other contracting parties
p.(None): of the EEA in whose territory the clinical trial is being conducted, as well as the responsible
p.(None): To inform the ethics committee about its measures and their reasons.
p.(None): (3) Does the Federal Office for Safety in Health Care have reasons to believe that the sponsor
p.(None): or the clinical investigator or any other party involved in the clinical trial does not meet its obligations
p.(None): more fulfilled, it must inform the concerned person immediately and give him the opportunity to comment
p.(None): and then inform him of an action plan that he must implement to remedy the situation. This
p.(None): applies even if the clinical trial has already ended. Obligation to notify according to paragraph 2 remains
p.(None): unaffected.
p.(None): general requirements
p.(None): § 41. (1) When planning, setting up and carrying out clinical trials, the health
p.(None): To keep risks and burdens for the test participant as low as possible.
p.(None): (2) The clinical trial of medical devices may only be carried out if the risks associated with
p.(None): you are connected to the test participants, measured by the expected meaning of the result of the
p.(None): Examination for medicine are justifiable and the risk of impairment of the
p.(None): Health of these subjects
p.(None): 1. is not significant or
p.(None): 2. is outweighed by the benefit to be assumed from the use of the medical device
p.(None): Health.
p.(None): (3) The clinical trial of medical devices may only be carried out on patients if the
p.(None): Application of the medical device according to the knowledge of medical science is indicated to
p.(None): for the patient on whom the clinical trial is to be carried out, a purpose in accordance with Section 2 (1)
p.(None): to reach.
p.(None): (4) The clinical trial of a medical device may only be carried out if all in the
p.(None): Precautions necessary to protect life related to clinical trial,
p.(None): the health and safety of the test participants, users or third parties have been taken and
...
p.(None): Carry out testing, monitoring and certification activities in accordance with this federal law.
p.(None): (2) Insofar as the bodies or institutions in accordance with paragraph 1 are accredited bodies within the meaning of
p.(None): Accreditation Act is the monitoring by the Federal Minister of Health and
p.(None): Consumer protection in agreement with the Federal Minister for Economic Affairs in
p.(None): To be carried out within the framework of Section 13 of the Accreditation Act.
p.(None): (3) The surveillance in accordance with paragraphs 1 and 2 can deal with all aspects that the
p.(None): proper execution of testing, monitoring and certi fi cation activities in accordance with this
p.(None): Federal law and the guarantee of medical device safety. You can in particular
p.(None): to monitor the existence of the necessary requirements for the implementation of test,
p.(None): Surveillance and certi fi cation activities under this federal law. Section 68 paras. 3 and 4 and
p.(None): 6 to 9 are used analogously.
p.(None): Section 3
p.(None): Reporting requirements, recording and evaluation of reports; investigations
p.(None): Announcements
p.(None): § 70. (1) Relatives of a legally regulated health care profession, business owners, the
p.(None): professionally authorized to operate or use a medical device, head of relevant
p.(None): Testing, inspection and certi fi cation bodies and technical safety officers from hospitals
p.(None): have information about medical devices regarding incidents, in particular
p.(None): 1. Any malfunction or change in the characteristics or performance of a medical device as well
p.(None): any deficiency in the labeling or in the instructions for use that are suitable for:
p.(None): Death or serious deterioration in a patient's health,
p.(None): a user or a third party or who has led to it, or
p.(None): 2. previously unknown serious side effects or the increased occurrence of known ones
p.(None): serious side effects, or
p.(None): 3. previously unknown mutual influences, or
p.(None): 4. serious quality defects,
p.(None): which have become known to you on the basis of your professional activity, immediately to the Federal Office of
p.(None): Healthcare security reporting, as well as all observations and data relevant to that
p.(None): Medical device safety can be important.
p.(None): (2) Reports in accordance with Paragraph 1 are in default at hospitals, except where there is any other danger,
p.(None): to be carried out uniformly by the medical director.
p.(None): (3) All natural or legal persons who place medical devices on the EEA for the first time
p.(None): and those companies, facilities or persons who place medical devices on the market have this
p.(None): Federal Office for Safety in Health Care immediately incidents according to paragraph 1 and above
p.(None): corrective measures, such as
p.(None): 1. Any technical or medical reason associated with a medical device that
p.(None): Systematic recall of medical devices of the same type from the market by the manufacturer
p.(None): has led
p.(None): 2. the issuing of a recommended measure,
p.(None): 3. the additional monitoring or modification of products,
p.(None): 4. Modifications to the product design of components or the manufacturing process, and
p.(None): 5. Modifications to the labeling or the instructions for use
p.(None): tell.
p.(None): (4) The Federal Office for Safety in Health Care has to take the necessary measures
p.(None): thus the person responsible for the first placing on the market in the EEA also of an incident
p.(None): is taught in accordance with paragraph 1.
p.(None): (5) To the extent that it ensures the uniformity and the information content of the reports
...
p.(None): to ensure that they are placed on the market for the first time as well as further, their commissioning and their operation,
p.(None): Prohibit, restrict, or comply with certain requirements
p.(None): addictive or to users, patients and third parties on dangers or appropriate
p.(None): To take precautions. As far as it is to prevent imminent dangers for
p.(None): the Federal Office for Safety in Health Care can do this
p.(None): Take measures without previous procedure or before issuing a decision. About here
p.(None): however, a written notification must be issued within four weeks.
p.(None): (2) Relate to measures in accordance with paragraph 1 of medical devices with a CE marking in accordance with this
p.(None): Federal law, the Federal Minister of Health and Consumer Protection has the
p.(None): Commission of the European Union and the other contracting parties to the Agreement on the
p.(None): Inform European Economic Area.
p.(None): (2a) Medical devices can also be covered by measures in accordance with Paragraph 1, their release
p.(None): has been suspended by the customs authorities in accordance with Article 27 (3) of Regulation (EC) № 765/2008. The
p.(None): In this case, the products concerned are in temporary storage in accordance with Article 50 of the Regulation
p.(None): (EEC) № 2913/92 of the Council of 12 October 1992 establishing the Community Customs Code, OJ.
p.(None): No.L 302 of October 19, 1992 (Customs Code).
p.(None): (3) Without prejudice to paragraph 1, the Federal Minister of Health has more detailed provisions on
p.(None): Preventing harmful effects of types or groups of medical devices or for protection
p.(None): the patient, user or third party by ordinance if this is for reasons of
p.(None): Health protection, medical device safety or in the interest of public health
p.(None): is necessary, and through this the Commission and the other parties to the European Union
p.(None): To inform the economic area accordingly. The Federal Minister of Health also went through
p.(None): Accompanying regulations required, in particular to determine
p.(None): Enforcement powers, with regard to relevant regulations of the European Union.
p.(None): Section 6
p.(None): Safety officer for medical devices; Medical device consultant
p.(None): Safety officer for medical devices
p.(None): § 78. (1) Who is responsible for the first placing on the market of medical devices in the
p.(None): Scope of the European Economic Area is and its seat in the scope of this
p.(None): Federal law, has a person with the expertise and knowledge necessary to carry out their duties
p.(None): Order reliability as a safety officer for medical devices.
p.(None): (2) The safety officer for medical devices has made known reports about risks
p.(None): Collect and evaluate medical devices and coordinate the necessary measures in accordance with Section 72.
p.(None): He is responsible for the fulfillment of the reporting obligations insofar as they concern medical device risks, and for cooperation
p.(None): responsible under the European Medical Device Monitoring System.
...
p.(None): Reserved person. In this regulation, the Federal Minister of Health and Consumer Protection
p.(None): also determine that certain types of medical devices are not self-service, through vending machines
p.(None): or may be delivered by mail order.
p.(None): (2) The Federal Minister of Health and Consumer Protection has for medical devices, their
p.(None): Installation, commissioning, operation, use or use of health professionals or institutions
p.(None): the health care system is reserved, or their safe and intended use or use
p.(None): is only guaranteed by health care facilities, by regulation to protect the
p.(None): Human health and safety stipulate that dispensing these medical devices only to them
p.(None): Persons or facilities.
p.(None): § 100. The Federal Minister of Health and Consumer Protection has by ordinance for
p.(None): Medical devices that are intended for use or use by laypeople and that
p.(None): 1. Human health, even if used as intended, directly or indirectly
p.(None): can be at risk if used without medical or dental supervision,
p.(None): or their application a medical or dental treatment, diagnosis or advice
p.(None): presupposes, or the
p.(None): 2. Often not used as intended to a considerable extent if this means that
p.(None): Human health is directly or indirectly endangered,
p.(None): to stipulate that they may only be given with a prescription.
p.(None): § 100a. (1) If a patient requests a prescription (prescription) to be presented in another party to the
p.(None): To use the Agreement on the European Economic Area, it must contain at least the following:
p.(None): a) the name and details of the prescribing doctor's professional qualifications and professional seat
p.(None): or dentist, including his email address and telephone or fax number with international
p.(None): Prefix,
p.(None): b) the name and date of birth of the person for whom the medical device is intended,
p.(None): c) the name and, if applicable, further information on the identity of the person prescribed
p.(None): Medical device,
p.(None): (d) the date of issue and
p.(None): e) the signature or qualified electronic signature of the prescriber.
p.(None): (2) Also prescriptions in the sense of § 100 are prescriptions that are in other contracting parties of the
p.(None): Agreement on the European Economic Area by a person authorized to prescribe there
p.(None): Taking into account the information in paragraph 1 on cross-border use were issued and in
p.(None): Austria to be submitted for tax.
p.(None): Section 101. Visiting persons who are neither authorized to sell medical devices, nor in
p.(None): Health care facilities operate for the purpose of collecting orders from
p.(None): Medical devices without a medical prescription are prohibited. It is also prohibited
p.(None): the order to do so.
p.(None): Section 3
p.(None): Advertising for medical devices
p.(None): misleading
p.(None): Section 102. (1) It is forbidden in connection with the placing of medical devices on the market
p.(None): To label or put up or to give information about these, the facts
p.(None): do not match or are misleading.
p.(None): (2) A misleading situation exists in particular if
p.(None): 1. medical devices are given a performance that they do not have,
p.(None): 2nd wrongly gives the impression that success can be expected with certainty or that
p.(None): Intended use, no harmful effects will occur or
...
p.(None): Operates or applies health care,
p.(None): is guilty of an administrative offense if the act is not threatened with judicial punishment and
p.(None): is to be punished with a fine of up to € 25,000, in the event of repetition up to € 50,000.
p.(None): Section 111a. The applies to all personal names used in this federal law
p.(None): chosen form for both genders.
p.(None): Section 3
p.(None): costs
p.(None): Section 111b. (1) The Federal Minister of Health and Women, in agreement with the
p.(None): Federal Minister of Finance Fees for those to be carried out under this Federal Act
p.(None): Official acts and activities of federal agencies, the necessity of which derives from this
p.(None): Federal law and the regulations or relevant legal acts of the
p.(None): European Union results, set in one tariff. Fees for reports can also be included in the tariff
p.(None): Section 67 and for reports in connection with implant registers in accordance with an ordinance pursuant to Section 73
p.(None): be determined.
p.(None): (2) When determining the chargeable facts, on the one hand, experience has shown that in the
p.(None): Average costs incurred, on the other hand on the importance or the benefit for the
p.(None): To take due account of fee debtors. The tariff and its changes are in the “Official Journal
p.(None): to the Wiener Zeitung ”.
p.(None): (3) Is the result of this federal law, the regulations issued on the basis thereof
p.(None): or legal acts of the European Union the need for official acts or activities of
p.(None): Federal agencies for which a tariff has not been set are the actual costs incurred
p.(None): prescribe.
p.(None): (4) For cash expenses, the party, regardless of the fees set in the tariff in accordance with § 76 of the
p.(None): General Administrative Procedure Act 1991, Federal Law Gazette No. 51.
p.(None): Section 4
p.(None): Final and transitional provisions
p.(None): § 112. (1) Medical devices within the meaning of Directive 93/42 / EEC, which are physically available as individual
p.(None): Products conforming to the regulations in force on December 31, 1994 before June 15
p.(None): Were placed on the market in Austria in 1998, and
p.(None): 1. which are safe and efficient,
p.(None): 2. whose expiry date has not passed and
p.(None): 3. which do not have to be installed or assembled by the end user,
p.(None): may still be put into operation during a transition period until June 30, 2001, unless
p.(None): the requirements according to § 8 are not fulfilled or measures according to § 77 are taken.
p.(None): (2) Medical devices for in vitro diagnosis, which are valid in Austria on December 7, 1998
p.(None): existing regulations, may continue until December 6, 2003 in Austria
p.(None): To be placed on the market. In vitro diagnostic medical devices placed on the market in this way may be used until the end of the
p.(None): Placed on the market or put into service in Austria on 6 December 2005, unless
p.(None): the requirements according to §§ 8, 9 and 11 are not met or measures according to § 77 are taken.
p.(None): There are changes to these regulations for the purpose of protecting human beings from one
p.(None): apply direct or indirect health hazards.
p.(None): (3) The Federal Minister of Health and Consumer Protection has, provided this with regard to the
...
Health / Cognitive Impairment
Searching for indicator impaired:
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p.(None): d) measures to ensure the safety of medical devices and to avert risks,
p.(None): in particular also according to § 72,
p.(None): e) the information and advertising material on the market,
p.(None): f) the performance of testing, monitoring and certi fi cation activities in accordance with this
p.(None): Federal law,
p.(None): g) the conformity assessment,
p.(None): h) the fulfillment of the basic requirements within the meaning of sections 8 and 9 and a regulation
p.(None): according to § 10 and other relevant information for medical device safety
p.(None): to request, inspect and, in justified cases, make copies or copies thereof and
p.(None): 5. to request all necessary information, in particular about the operations mentioned in item 4.
p.(None): (8) Companies, facilities and people in accordance with paragraph 1 must tolerate measures in accordance with paragraphs 5 to 7
p.(None): and the bodies responsible for monitoring the Federal Office for Safety in Health Care, the
p.(None): Federal Ministry of Health and Women and the experts commissioned in accordance with paragraph 2
p.(None): to support the fulfillment of their tasks. You are committed to these premises
p.(None): Medical devices and records to make the prescribed or regulatory
p.(None): to allow the ordered test, to provide the necessary staff and resources and the
p.(None): To provide information and to submit the documents necessary for the fulfillment of the tasks of the monitoring
p.(None): entrusted bodies or the experts commissioned in accordance with paragraph 2 are required.
p.(None): (9) The official acts in accordance with paragraphs 5 to 8 are, except in the event of imminent danger or if the
p.(None): there is reasonable reason to believe that the effectiveness of the official act will be impaired during the
p.(None): Carry out operating times and announce them in advance. The organs and the experts according to paragraph 2
p.(None): in their surveillance activities must take care that each is not absolutely necessary
p.(None): Disruption or hindrance to the activities of companies, facilities or persons in accordance with paragraph 1
p.(None): is avoided.
p.(None): (10) The Federal Minister of Health and Women has an appropriate perspective
p.(None): and effective control for the following calendar year a directive on the implementation of the
p.(None): To issue inspections (inspection plan). The Federal Office for Safety in Health Care has under
p.(None): Compliance with this guideline and the Federal Ministry of Health and Women by
p.(None): Report on the execution on March 31 of the following calendar year.
p.(None): (11) Market surveillance authority within the meaning of Regulation (EC) № 765/2008 of the European
p.(None): Parliament and of the Council of 9 July 2008 on the rules for accreditation and
p.(None): Market surveillance in connection with the marketing of products and the lifting of
p.(None): Regulation (EEC) № 339/93 for products within the meaning of this federal law is the Federal Office for
p.(None): Healthcare security.
p.(None): (12) The Federal Office for Safety in Health Care has in accordance with the requirements of
p.(None): Federal Ministry of Health to create market surveillance programs for medical devices and
p.(None): to update and carry out regularly. These are for the Federal Minister of Health
p.(None): To submit approval. The Federal Office for Safety in Health Care has these programs
p.(None): to other Member States and the European Commission and to the public by means of
...
Searching for indicator impairment:
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p.(None): Section 32. (1) Notwithstanding Sections 15 and 27, the Federal Office for Safety in Health Care
p.(None): on request the placing on the market and the commissioning of individual medical devices for which the
p.(None): Conformity assessment procedures according to a regulation according to § 28 were not carried out, only in
p.(None): Allow Austria if their use is necessary in the interest of health protection.
p.(None): (2) The Federal Minister of Health and Consumer Protection has through the regulation in accordance with § 28
p.(None): considering an adequate supply of safe and efficient medical devices
p.(None): and the availability of equivalent medical devices, for which the procedures according to §§ 15 and 27
p.(None): have already been carried out to determine the more specific conditions under which the
p.(None): Exemption according to paragraph 1 can be granted, including the type and content of the applications and the
p.(None): the documents to be attached in accordance with paragraph 1.
p.(None): (3) When deploying the Federal Army in accordance with Section 2 (1) lit. a of the Wehrgesetzes 2001 and at
p.(None): Immediate preparation of this deployment is for placing on the market and commissioning individual
p.(None): in this case of medical devices required an exemption according to paragraph 1 is not required.
p.(None): (4) An exemption within the meaning of paragraph 1 is not required if a in Austria for
p.(None): Self-employed professional authorized doctor confirms that a medical device is for a specific
p.(None): Patients to avert a life threatening or a serious health impairment
p.(None): is necessary and the success of treatment with a medical device, in which the procedure according to §§ 15
p.(None): and 27 have already been carried out, are unlikely to be achieved.
p.(None): Systems and treatment centers; Sterilization for placing on the market
p.(None): Section 33. (1) Any natural or legal person, each with a CE marking
p.(None): Medical devices of the directive 93/42 / EEC according to their purpose and within the
p.(None): Application restrictions provided by the manufacturer are put together in the form of a system or
p.(None): Placing a treatment unit on the market for the first time must provide an explanation of the content
p.(None): have ready that
p.(None): 1. the mutual compatibility of medical devices according to the instructions of the manufacturers
p.(None): checked and carried out the work steps according to the instructions,
p.(None): 2. it packs the system or the treatment center and pertinent user instructions,
p.(None): including the relevant instructions from the manufacturer, and
p.(None): 3. the entire activity has been suitably monitored and controlled internally.
p.(None): (2) Are systems or treatment units with medical devices of Directive 93/42 / EEC, the
p.(None): do not have a CE marking within the meaning of this Federal Act or for the first time in a type and form in
p.(None): Placed on the market that are not the original purpose and those provided by the manufacturer
p.(None): If the application restrictions are met, the system or the treatment center becomes independent
p.(None): Medical device treats and as such is subject to the provisions provided for it
p.(None): Ordinance in accordance with section 28 (1) and the procedures laid down therein.
p.(None): § 34. Any natural or legal person, the systems or treatment units according to § 33 or
p.(None): other medical devices of Directive 93/42 / EEC with CE marking, for which the manufacturer issues a
...
p.(None): Suspends or prohibits review, the other EEA Contracting Parties, the relevant ethics committee,
p.(None): and the European Commission stating the reasons for its decision to conduct the clinical trial
p.(None): suspend or prohibit, inform. Has the Federal Office for Safety in Health Care
p.(None): ordered a significant change in a clinical trial, it has the other contracting parties
p.(None): of the EEA in whose territory the clinical trial is being conducted, as well as the responsible
p.(None): To inform the ethics committee about its measures and their reasons.
p.(None): (3) Does the Federal Office for Safety in Health Care have reasons to believe that the sponsor
p.(None): or the clinical investigator or any other party involved in the clinical trial does not meet its obligations
p.(None): more fulfilled, it must inform the concerned person immediately and give him the opportunity to comment
p.(None): and then inform him of an action plan that he must implement to remedy the situation. This
p.(None): applies even if the clinical trial has already ended. Obligation to notify according to paragraph 2 remains
p.(None): unaffected.
p.(None): general requirements
p.(None): § 41. (1) When planning, setting up and carrying out clinical trials, the health
p.(None): To keep risks and burdens for the test participant as low as possible.
p.(None): (2) The clinical trial of medical devices may only be carried out if the risks associated with
p.(None): you are connected to the test participants, measured by the expected meaning of the result of the
p.(None): Examination for medicine are justifiable and the risk of impairment of the
p.(None): Health of these subjects
p.(None): 1. is not significant or
p.(None): 2. is outweighed by the benefit to be assumed from the use of the medical device
p.(None): Health.
p.(None): (3) The clinical trial of medical devices may only be carried out on patients if the
p.(None): Application of the medical device according to the knowledge of medical science is indicated to
p.(None): for the patient on whom the clinical trial is to be carried out, a purpose in accordance with Section 2 (1)
p.(None): to reach.
p.(None): (4) The clinical trial of a medical device may only be carried out if all in the
p.(None): Precautions necessary to protect life related to clinical trial,
p.(None): the health and safety of the test participants, users or third parties have been taken and
p.(None): the medical device with the exception of the aspects that are the subject of the clinical trial
p.(None): basic requirements in accordance with sections 8 and 9 and a regulation in accordance with section 10.
p.(None): (5) The manufacturer of a medical device intended for clinical trials has all the necessary
p.(None): Measures to be taken to ensure the conformity of the manufactured items
p.(None): Ensure medical devices with the documentation according to an ordinance according to § 66. He has one
p.(None): Assessment of the effectiveness of these measures and, if necessary, an inspection by the Federal Office for
p.(None): Allow healthcare security.
p.(None): (6) When planning, creating, executing and evaluating clinical trials of
p.(None): Medical devices and performance assessment tests of in vitro diagnostic medical devices are ethical
p.(None): Principles for human medical research of the Helsinki Declaration of World Medical
p.(None): Association, as amended by the 59th General Assembly of the World Medical Association, Seoul, October
...
p.(None): other predictable risks, including the risk threshold as well as the
p.(None): Degree of exposure specifically defined and constantly checked,
p.(None): 9. The test plan by an ethics committee that has knowledge in the field of children and
p.(None): Juvenile medicine or who deals with clinical, ethical and psychosocial issues on the
p.(None): Had been advised in the area of pediatrics and adolescent medicine, and was approved
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of
p.(None): Science stand.
p.(None): (2) Deviating from Paragraph 1 No. 2, a clinical trial on minors is also permitted if
p.(None): 1. The clinical trial is an essential extension of the scientific understanding of the
p.(None): Condition, illness or disorder of the minor and thereby either
p.(None): Can benefit patients or the patient group to which the minor belongs, and
p.(None): 2. The clinical trial for the minor with only a minimal risk and minimal burden
p.(None): brings oneself; a clinical trial has minimal risk and minimal burden if
p.(None): it is to be expected that at most it will be a minor and merely temporary
p.(None): Impairment and any symptoms or inconveniences can be very minor
p.(None): and will only appear temporarily.
p.(None): § 52. The clinical trial may be carried out on a person who is the result of a mental illness or a
p.(None): comparable impairment of their ability to make decisions has a legal representative or on
p.(None): judicial or official order stopped or according to the Housing Act, BGBl.
p.(None): No. 155/1990, is not carried out.
p.(None): Section 52a. (1) A clinical trial, by its nature, can only be used in emergency situations in which appropriate
p.(None): Time no consent of the legal representative can be obtained, can be carried out at
p.(None): a person who is unable to consent to have a clinical trial performed if:
p.(None): 1. There are no indications that either the patient refused the clinical trial
p.(None): or would reject or the requirements of Section 52 exist,
p.(None): 2. Such research for the validation of data used in clinical trials for consent
p.(None): have been obtained by persons capable of providing information or using other research methods, and
p.(None): absolutely necessary for the clinical evaluation of the safety and effectiveness of the medical device
p.(None): are and can only be carried out in emergency situations,
p.(None): 3. the medical device that is being tested to fulfill a purpose as defined in Section 2 (1)
p.(None): Z 1 to 3 is determined in an emergency situation,
p.(None): 4. the use of the medical device that is being tested according to the knowledge of the medical
p.(None): Science is indicated to help the emergency patient
p.(None): a) to recognize, prevent, monitor, treat or alleviate an illness,
...
Health / Drug Usage
Searching for indicator drug:
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p.(None): h) system
p.(None): for the in vitro analysis of samples from the human body, including
p.(None): Blood and tissue donation is used, and
p.(None): 2. serves solely or predominantly to
p.(None): a) Information about physiological or pathological conditions or congenital anomalies
p.(None): give or
p.(None): (b) check the safety and tolerability of the potential recipients, or
p.(None): c) monitor a therapeutic measure.
p.(None): Sample containers, evacuated or non-evacuated, by the manufacturer are also considered to be in vitro diagnostics
p.(None): especially for the in vitro analysis of samples from the human body as
p.(None): Primary container are intended for storage. Products for general laboratory needs do not apply
p.(None): as in vitro diagnostics, unless they are based on their characteristics according to the manufacturer
p.(None): to use the intended purpose for in vitro investigations within the meaning of Z 2.
p.(None): (5a) "In-vitro diagnostic for self-use" is any in-vitro diagnostic that is based on the
p.(None): Manufacturer specified purpose of laypersons can be applied in the home environment.
p.(None): (5b) “Calibration and control material” are substances, materials and objects that are manufactured by your
p.(None): Manufacturer to compare measurement data or to test the performance characteristics of an in vitro
p.(None): Diagnostic agents are intended for the application for which it is intended.
p.(None): (5c) "Medical device with a derivative from human blood" is a medical device according to the
p.(None): Directive 90/385 / EEC or Directive 93/42 / EEC, which contains a substance as a component, which - separately
p.(None): used - as a drug component or drug from human blood or blood plasma in the sense
p.(None): of Art. 1 Point 10 of Directive 2001/83 / EC and in addition to the medical device
p.(None): can have an effect on the human body. The aforementioned shock is referred to below as “derivative
p.(None): from human blood ”.
p.(None): (6) "Custom-made products" are all medical devices, with the exception of in vitro diagnostic medical devices, which according to
p.(None): written prescription from a doctor or another legally based on their professional qualifications
p.(None): authorized person, under their responsibility, specially made according to speci fi c design criteria
p.(None): and are intended for exclusive use in a named patient.
p.(None): Standard medical devices that have to be adapted to the speci fi c
p.(None): To meet the requirements of the doctor or any other licensed user authorized to do so,
p.(None): are not considered to be custom-made.
p.(None): (7) "Manufacturer" is any natural or legal person responsible for the design, manufacture, packaging
p.(None): and labeling a medical device with a view to placing it on the market for the first time
p.(None): Name is responsible. This applies regardless of whether these activities are carried out by this person or
p.(None): Company or acting on behalf of a third party.
p.(None): (8) A manufacturer is also any natural or legal person who has one or more prefabricated ones
p.(None): Assembled, packaged, treated, prepared or labeled products or for determining the products
p.(None): Intended use as a medical device with regard to the placing on the market in your own name
p.(None): is. However, a manufacturer is not someone who has already been placed on the market without being a manufacturer within the meaning of paragraph 7
p.(None): Assembled products for a named patient according to their intended use
p.(None): adapts.
...
p.(None): January 21, 2006: Food Safety and Consumer Protection Act - LMSVG, BGBl. I No. 13/2006)
p.(None): 3. human blood, blood products, blood plasma or blood cells of human origin or products,
p.(None): blood products, blood plasma or blood cells of this type at the time of placing on the market
p.(None): included, with the exception of in vitro diagnostics and medical devices within the meaning of § 2
p.(None): Paragraph 5c,
p.(None): 4. Organs, tissues or cells of human origin as well as products containing tissues or cells
p.(None): contain human origin or were obtained from such tissues or cells, be it
p.(None): because they are in-vitro diagnostics or medical devices according to § 2 Paragraph 5c,
p.(None): 5. Transplants, tissues or cells of animal origin unless a medical device is used
p.(None): Use of killed animal tissue or products made
p.(None): were obtained from animal tissue or are in-vitro diagnostics,
p.(None): 6. Natural healing deposits and products from a natural healing deposit within the meaning of Section 42a
p.(None): Paragraph 2 of the Federal Act on Hospitals and Health Centers, Federal Law Gazette No. 1/1957.
p.(None): (2) This Federal Act does not affect the 1994 Industrial Code, Federal Law Gazette No. 194.
p.(None): § 4a. (1) Medical devices according to Directive 93/42 / EEC, which are also used by the manufacturer
p.(None): determined according to the regulations for personal protective equipment of the directive 89/686 / EEC
p.(None): are also subject to the provisions of this federal law.
p.(None): (2) Medical devices according to directives 90/385 / EEC and 93/42 / EEC, which are also machines in the sense
p.(None): of Article 2 letter a of Directive 2006/42 / EC are subject to the provisions of this
p.(None): Federal law.
p.(None): Differentiation from drug regulations
p.(None): Section 5
p.(None): are to apply a drug within the meaning of the drug law, are subject to this federal law
p.(None): without prejudice to the provisions of the Medicinal Products Act relating to medicinal products.
p.(None): (2) Is a combination of medical device and medicinal product placed on the market in such a way that
p.(None): Medical device and drug form a single, interconnected product, the
p.(None): main intended effect is based on the abusive composition of the drug and that
p.(None): is intended for use in this connection only and is not reusable
p.(None): this product the drug law. The Federal Office for Safety in Health Care has at
p.(None): Assessment of the medical device part the basic requirements according to the II
p.(None): Federal law to apply, insofar as safety and performance-related medical device functions
p.(None): are affected.
p.(None): (3) Contains a medical device - with the exception of in vitro diagnostic medical devices - as an integrated component
p.(None): Sto ff, which - used separately - as a medicinal product within the meaning of the Medicinal Products Act and in addition to
p.(None): the medical device can have an effect on the human body, it is a
p.(None): Medical device in the sense of this federal law.
p.(None): (4) If a medical device contains a derivative of human blood as part of Section 2
p.(None): Paragraph 5c, this medical device is also subject to this federal law.
p.(None): Approval procedure
p.(None): § 5a. (1) The Federal Office for Safety in Health Care has at the request of a manufacturer or
p.(None): its authorized representative in the event that a product is intended to be placed on the market for the first time
p.(None): to determine whether this product fulfills one of the definitions according to § 2 Paragraphs 1 to 6 and, if necessary, via
p.(None): to decide on the classification and classi fi cation of the medical device. The manufacturer or
p.(None): whose authorized representative is domiciled in Germany. As part of this procedure, there may be an opinion
p.(None): Obtain the delimitation and classification advisory board in accordance with § 5b.
p.(None): (2) The Federal Office for Safety in Health Care may also make determinations in accordance with para
p.(None): carry out for office. The delimitation and classification advisory board can also provide an expert opinion
p.(None): obtain according to § 5b.
...
Searching for indicator influence:
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p.(None): (14) "Exhibiting" is the setting up or demonstration of medical devices for the purpose of advertising or
p.(None): the information of the specialist circles.
p.(None): (15) "Harmonized standards" are national standards of the contracting states to the Agreement on the
p.(None): European Economic Area implementing relevant harmonized European standards, their
p.(None): Locations as "harmonized standards" for medical devices in the Official Journal of the European Communities
p.(None): have been published. The harmonized standards are relevant monographs of the European
p.(None): Pharmacopoeia for medical devices, their sources in the Official Journal of the European
p.(None): Communities have been released. The harmonized standards are also common
p.(None): Technical speci fi cations that are in accordance with Article 7 (2) of Directive 98/79 / EC of the European Parliament
p.(None): and the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331 of 7 December 1998)
p.(None): adopted and published in the Official Journal of the European Communities. In these
p.(None): Speci fi cations are used in a suitable manner to define the criteria for the evaluation and re-evaluation of the
p.(None): Performance, the batch release criteria, the reference methods and the reference materials.
p.(None): (16) "Notified Body" is one of a Contracting Party to the Agreement on the European
p.(None): Economic area of the European Commission and the other contracting parties for the
p.(None): Execution of tasks in the context of conformity assessment procedures for medical devices
p.(None): notified body.
p.(None): (17) “Side effects” are those when the medical device is used as intended
p.(None): occurring and related undesirable side effects.
p.(None): (18) "Mutual influence" means those that occur when used as intended
p.(None): Effects of
p.(None): 1. Medical devices on top of each other or
p.(None): 2. Medical devices and other objects, substances or preparations made of substances on top of each other.
p.(None): (19) "Maintenance" of a medical device is the entirety of the measures for preservation and
p.(None): Restoration of the desired target state and for the determination and assessment of the
p.(None): Current state of a medical device. The term "maintenance" includes inspection, maintenance and
p.(None): Repair.
p.(None): (20) "Inspection" of a medical device is the entirety of all measures to determine and
p.(None): Assessment of the current status.
p.(None): (21) "Maintenance" of a medical device is the entirety of all measures for the preservation of the
p.(None): desired target state, the flawless safety and functionality of the medical device
p.(None): guaranteed.
p.(None): (22) "Repair" of a medical device are the measures to restore the
p.(None): specified target state, the flawless safety and functionality of the medical device
p.(None): guaranteed.
p.(None): (23) 'Healthcare institution' means any institution, post or institution in which
p.(None): Medical devices used by healthcare professionals or authorized professionals
p.(None): operated or applied, including those of the Federal Army that the
p.(None): Serve medical supplies.
p.(None): Definitions for clinical evaluation and testing of medical devices as well as for
p.(None): Performance assessment testing of in vitro diagnostic medical devices
p.(None): § 3. (1) "Clinical evaluation" is the medical evaluation of a medical device in the sense of
p.(None): Annex 7 № 1.1 of Council Directive 90/385 / EEC of June 20, 1990 on the approximation of the
p.(None): Member States legislation on active implantable medical devices, OJ. EG № L 189
...
p.(None): Section 37. (1) The notified body, its manager and that by carrying out the assessments and tests
p.(None): Commissioned personnel must be independent of the body responsible for the medical device to be assessed
p.(None): has developed or constructed, as well as by its manufacturer, distributor, installer or user. they may
p.(None): neither directly nor as an agent for the development or construction, the manufacture, the sales
p.(None): or be involved in the maintenance of these products for the applicant. The possibility of one
p.(None): This does not result in the exchange of technical information between the manufacturer and the notified body
p.(None): locked out.
p.(None): (2) The notified body must be capable of all in accordance with a conformity assessment procedure
p.(None): a regulation provided for in § 28 tasks which are assigned to such a position and for which
p.(None): it is designated to perceive, be it that these tasks are performed by the notified body itself or be it that it
p.(None): are carried out in some areas under their responsibility. You must in particular about the staff
p.(None): dispose of and possess the means necessary to carry out the implementation of the assessments and examinations
p.(None): associated medical-scientific, technical and administrative tasks required
p.(None): are. You must have the equipment necessary for the tests and surveillance
p.(None): however, in some areas operate external facilities if access to them is regulated and their
p.(None): Suitability is ensured.
p.(None): (3) The body and the personnel responsible for the examination must include the evaluations and examinations
p.(None): carry out the required expertise and reliability in the field of medical devices and
p.(None): regardless of any possible influence, especially of a financial nature, on their assessment or the
p.(None): Be the results of their test.
p.(None): (4) If a Notified Body determined after establishing the agreement with the client
p.(None): If it submits work related to the conformity assessment to a subcontractor
p.(None): ensure beforehand that the provisions of this section are observed by the subcontractor.
p.(None): The notified body has the relevant documents to assess the technical competence of the
p.(None): Subcontractor and on the work carried out by the latter within the framework of this Federal Act on
p.(None): To be available for inspection by the responsible authorities.
p.(None): (5) Only parts of conformity assessment procedures to be subcontracted may be smaller
p.(None): Make up part of the total order. Overall responsibility for carrying out a
p.(None): The notified body must in any case carry out the conformity assessment procedure.
p.(None): (6) The personnel responsible for the examinations must meet the following requirements:
p.(None): 1. the necessary basis for the assessments and tests for which the position has been designated
p.(None): Qualification,
p.(None): 2. Adequate knowledge of the regulations for the tests carried out by him and a
p.(None): sufficient practical experience in this area and
p.(None): 3. those for carrying out the tests and drafting the certificates, protocols and
p.(None): Reports, in which the tests carried out are recorded, suitability required.
p.(None): (7) The independence of the personnel commissioned with the examination must be ensured. The high of
p.(None): Payments to each examiner may not be based on the number of examinations he has carried out or the number of examinations
p.(None): Judge the results of these tests.
p.(None): (8) For cases of liability that may arise from their work, the notified body must:
...
p.(None): approval by the responsible ethics committee. With the
p.(None): Performance assessment testing of in vitro diagnostic medical devices according to the directive 98/79 / EG, which according to § 15 the CE
p.(None): If the performance assessment test does not indicate any other purpose of the
p.(None): In-vitro diagnostics as the object of the conformity assessment - after
p.(None): approval by the responsible ethics committee. Section 47 does not apply.
p.(None): (6) The sponsor has the Federal Office for Safety in Health Care and the responsible
p.(None): Authorities of other affected EEA parties to the completion of the clinical trial, in the event of a
p.(None): early termination with a corresponding reason. This message also sent to the
p.(None): competent authorities of all other EEA contracting parties and the European Commission
p.(None): take place if the premature termination occurs for security reasons. The final report according to
p.(None): Annex 7 section 2.3.7 of Directive 90/385 / EEC or Annex X section 2.3.7 of Directive 93/42 / EEC
p.(None): is for the Federal Office for Safety in Health Care and the competent authorities of the others
p.(None): to keep the relevant EEA contracting parties available.
p.(None): (7) Reports in accordance with paragraphs 1, 2, 3 and 6, § 40b and § 42 paragraph 8 must be in accordance with a
p.(None): Regulation according to § 67 in the way of the European database for medical devices.
p.(None): Modification of the test plan
p.(None): Section 40a. (1) After the clinical trial begins, the sponsor may change the trial schedule. If the
p.(None): Change is significant and affects in particular the safety of the test participants or the
p.(None): The sponsor of clinical trials can influence the scientific significance of the clinical trial
p.(None): Examinations according to § 40 Paragraphs 2 and 3 of the Federal Office for Safety in Health Care and the
p.(None): report the content of the change and all reasons for it to the responsible ethics committee. In clinical
p.(None): The sponsor of the responsible ethics committee has the content of the change and
p.(None): to report all reasons for this.
p.(None): (2) In the case of a clinical trial pursuant to Section 40 (2), the change can be made after a positive opinion
p.(None): the responsible ethics committee for a report in accordance with paragraph 1, provided that
p.(None): Federal Office for Safety in Health Care not within a period of 35 days after
p.(None): Proper notification of the change to the clinical trial to protect the trial subject
p.(None): public health or due to other non-existence of the requirements of section 41 (4)
p.(None): prohibited or approved the implementation of the change before this period.
p.(None): (3) In the case of a clinical trial pursuant to Section 40 (3), the change can be made after a positive opinion
p.(None): the responsible ethics committee on a report in accordance with paragraph 1 and reimbursement of the report in accordance with paragraph 1
p.(None): to the Federal Office for Safety in Health Care.
p.(None): (4) In the case of a clinical trial in accordance with Section 40 (5), the change can be made after a positive opinion
...
p.(None): Bring traffic or put it together within the meaning of Section 33 (1), the medical devices professionally or
p.(None): professionally maintain, convert, assemble, adapt or process the medical devices professionally
p.(None): or professionally clean, disinfect or sterilize or medical devices in facilities of the
p.(None): With regard to these activities, the application or operation of health care is subject to
p.(None): Monitoring.
p.(None): (2) Monitoring within the meaning of paragraph 1 is carried out by the organs of the Federal Office for Security in the
p.(None): Healthcare, the Federal Minister of Health and Women or by commissioned by them
p.(None): Expert. The activity of relevant accredited bodies, from
p.(None): Federal Minister of Health and Women recognized organizer of proficiency tests, by operators of
p.(None): Medical device registries or other organizers from the Federal Minister of Health and Women
p.(None): recognized cross-regional comparative tests and assessments related to
p.(None): Medical devices.
p.(None): (3) Insofar as within the scope of conformity assessment procedures according to a regulation according to § 28
p.(None): Monitoring is provided, it is carried out by the for the respective conformity assessment procedure
p.(None): competent notified body. Monitoring by notified bodies is carried out in accordance with a regulation
p.(None): according to § 28.
p.(None): (4) The monitoring pursuant to Paragraph 1 can relate to all aspects that affect security,
p.(None): Functionality and quality of medical devices as well as the protection of health and safety
p.(None): Can influence patients, users or third parties.
p.(None): (5) The surveillance of health care facilities can take into account the
p.(None): The respective hazard potential is carried out systematically, on a sample basis or in the event of an incident, especially in the
p.(None): With regard to possible threats to the life or health of patients, users or third parties
p.(None): in connection with medical devices or with a view to ensuring a quality-assured
p.(None): Provision, application and maintenance of medical devices in the interest of health. Lies a
p.(None): Violation of provisions of this federal law or on the basis of decrees issued
p.(None): before, the institution must be instructed to remedy the defects within a reasonable period of time. comes
p.(None): when surveillance reveals that a violation of the provisions of this federal law or
p.(None): on the basis of enacted regulations the life and health of patients, users
p.(None): or third parties is endangered, the necessary measures to protect life and the
p.(None): Health of these people.
p.(None): (6) The monitoring of facilities and establishments by establishments, facilities or persons
p.(None): have been commissioned with the storage and transport of medical devices within the meaning of paragraph 1
p.(None): only permitted if circumstances exist which justify the assumption that medical devices are stored or
p.(None): the means of transport are misused as storage facilities via which to process the
p.(None): Transport agendas may be used beyond the time required.
p.(None): (7) The organs of the Federal Office for Safety in Health Care, the Federal Ministry for
p.(None): Health and women and the experts commissioned in accordance with paragraph 2 are authorized to
...
Searching for indicator substance:
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p.(None): b) reagent product,
p.(None): c) calibration material,
p.(None): d) control material,
p.(None): e) kit,
p.(None): f) instrument,
p.(None): g) apparatus, device or
p.(None): h) system
p.(None): for the in vitro analysis of samples from the human body, including
p.(None): Blood and tissue donation is used, and
p.(None): 2. serves solely or predominantly to
p.(None): a) Information about physiological or pathological conditions or congenital anomalies
p.(None): give or
p.(None): (b) check the safety and tolerability of the potential recipients, or
p.(None): c) monitor a therapeutic measure.
p.(None): Sample containers, evacuated or non-evacuated, by the manufacturer are also considered to be in vitro diagnostics
p.(None): especially for the in vitro analysis of samples from the human body as
p.(None): Primary container are intended for storage. Products for general laboratory needs do not apply
p.(None): as in vitro diagnostics, unless they are based on their characteristics according to the manufacturer
p.(None): to use the intended purpose for in vitro investigations within the meaning of Z 2.
p.(None): (5a) "In-vitro diagnostic for self-use" is any in-vitro diagnostic that is based on the
p.(None): Manufacturer specified purpose of laypersons can be applied in the home environment.
p.(None): (5b) “Calibration and control material” are substances, materials and objects that are manufactured by your
p.(None): Manufacturer to compare measurement data or to test the performance characteristics of an in vitro
p.(None): Diagnostic agents are intended for the application for which it is intended.
p.(None): (5c) "Medical device with a derivative from human blood" is a medical device according to the
p.(None): Directive 90/385 / EEC or Directive 93/42 / EEC, which contains a substance as a component, which - separately
p.(None): used - as a drug component or drug from human blood or blood plasma in the sense
p.(None): of Art. 1 Point 10 of Directive 2001/83 / EC and in addition to the medical device
p.(None): can have an effect on the human body. The aforementioned shock is referred to below as “derivative
p.(None): from human blood ”.
p.(None): (6) "Custom-made products" are all medical devices, with the exception of in vitro diagnostic medical devices, which according to
p.(None): written prescription from a doctor or another legally based on their professional qualifications
p.(None): authorized person, under their responsibility, specially made according to speci fi c design criteria
p.(None): and are intended for exclusive use in a named patient.
p.(None): Standard medical devices that have to be adapted to the speci fi c
p.(None): To meet the requirements of the doctor or any other licensed user authorized to do so,
p.(None): are not considered to be custom-made.
p.(None): (7) "Manufacturer" is any natural or legal person responsible for the design, manufacture, packaging
p.(None): and labeling a medical device with a view to placing it on the market for the first time
p.(None): Name is responsible. This applies regardless of whether these activities are carried out by this person or
p.(None): Company or acting on behalf of a third party.
p.(None): (8) A manufacturer is also any natural or legal person who has one or more prefabricated ones
p.(None): Assembled, packaged, treated, prepared or labeled products or for determining the products
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Searching for indicator usage:
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p.(None): to set appropriate access rights.
p.(None): (5) Personal data must be pseudonymized immediately. When processing data according to
p.(None): Paragraphs 1 and 2 are for patient identification only the use of the area-speci fi c
p.(None): Personal identifier GH and AS (Section 10 Paragraph 2 E-Government Act, Federal Law Gazette I № 10/2004) permitted. The
p.(None): Area-specific personal identifiers AS may only be used and saved in encrypted form
p.(None): become. The direct personal reference must be irreversibly deleted immediately after conversion.
p.(None): (6) The area-specific personal identifiers are to be deleted as soon as they are used for the purposes
p.(None): Paragraph 1 are no longer required. The Federal Statistics Austria has health Austria
p.(None): GmbH - at their request - personal data on the time of death and the cause of death of
p.(None): To transmit persons whose data are stored in an implant register in accordance with paragraph 1.
p.(None): (Note: Paragraph 7 repealed by Art. 47 Z 29, Federal Law Gazette I No. 37/2018)
p.(None): (8) The managing director of Gesundheit Österreich GmbH has to ensure that the clear
p.(None): Identity and role of those authorized to access the state of the art for each access
p.(None): be proven and recorded. He must ensure that the appropriate state of the art
p.(None): Technically appropriate precautions are taken in order to destroy or change the data
p.(None): prevent program errors (viruses) and to destroy, change or query the
p.(None): Prevent data from the registry from unauthorized users or systems. Furthermore, he has to
p.(None): ensure that all usage processes, such as entries, changes,
p.(None): Queries and transmissions are traceable. He has to create a data security concept for
p.(None): the employee of Gesundheit Österreich GmbH is binding.
p.(None): (9) The healthcare institutions participating in the registers may access data in the
p.(None): Access registers for scientific purposes in pseudonymized form.
p.(None): (10) Any access to the data processed or to be processed in the registers by the
p.(None): Gesundheit Österreich GmbH may only be used for the purposes of paragraph 1.
p.(None): (11) The Federal Office for Safety in Health Care is entitled to the in the registers
p.(None): access processed data in pseudonymized form if this is for the purpose of protecting the
p.(None): Health and safety of patients, for warding off risks and for the purpose of
p.(None): Medical device vigilance and market surveillance is necessary.
p.(None): (12) The managing director of Gesundheit Österreich GmbH is obliged to have access authorization for
p.(None): assign the individual users of Gesundheit Österreich GmbH individually. The authorized users of the
p.(None): Gesundheit Österreich GmbH are aware of the provisions of the General Data Protection Regulation and that
p.(None): To teach data security concept. These access rights are deprived of their access rights,
p.(None): if they no longer need them for the further fulfillment of the tasks assigned to them or they
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.(None): Case, the assessing ethics committee must also announce all of the auditors involved and all of them
p.(None): Documents are made available that provide an assessment with regard to their professional quali fi cation
p.(None): and experience, as well as the existing facilities and staff.
p.(None): Section 58. (1) The governor has with regard to clinical trials outside of hospitals
p.(None): Ensure that independent ethics committees are responsible in the area of his state
p.(None): A sufficient number of tasks are performed in accordance with Section 60.
p.(None): (2) For clinical trials at hospitals, the responsible ethics committee in accordance with § 8c
p.(None): Hospital Act, Federal Law Gazette No. 1/1957.
p.(None): (3) The appointment of ethics committees in accordance with paragraph 1 is the Federal Ministry of Health and
p.(None): Women and the Federal Office for Safety in Health Care display.
p.(None): (4) The ethics committee must at least consist of:
p.(None): 1. a doctor who is authorized to practice his profession independently in Germany,
p.(None): 2. a specialist in whose specialty is the clinical examination of the medical device,
p.(None): 3. a representative of the nursing service,
p.(None): 4. a lawyer,
p.(None): 5. a pharmacist,
p.(None): 6. a technical safety officer of a hospital,
p.(None): 7. a patient representative,
p.(None): 8. a representative of a representative organization for the disabled and
p.(None): 9. Another person who does not fall under Z 1 to 8 and who is concerned with pastoral care
p.(None): Is entrusted with matters or otherwise has the required ethical competence. additional
p.(None): Experts are to be involved as far as the assessment of a clinical trial requires. The
p.(None): Ethics Committee has to be made up of women and men. Doing so if possible
p.(None): to pay attention to a balanced relationship. A representative must be appointed for each member. The in Z 1
p.(None): and 2 listed members of the ethics committee are not allowed to have clinical examiners in the frame
p.(None): the clinical trial to be assessed.
p.(None): Section 59. (1) The members of the Ethics Committee and their deputies must perform this function
p.(None): be free of instructions. You have any relationships with manufacturers or distributors of medical devices
p.(None): completely open to the governor. They have become active in the
p.(None): Ethics Committee - without prejudice to any other reasons for bias - in all matters
p.(None): contain, in which such a relationship is likely to question its full impartiality.
p.(None): (1a) Internal quality assurance measures shall be provided within the framework of the organization
p.(None): Ensure in particular the regularity of the processes and procedures.
p.(None): (2) The implementation of the agendas of the ethics committee and the proper establishment
p.(None): Its decisions and statements must be set out in writing in the rules of procedure, which of the
p.(None): Approval by the responsible governor is required.
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): Medical devices,
p.(None): 3. for the purpose of quality assurance of implantable medical devices,
p.(None): 4. for the purpose of statistics as a basis for planning, quality assurance and quality reporting
p.(None): in Austrian healthcare and
p.(None): 5. for scientific purposes
p.(None): Implant register for active implantable medical devices, soft tissue implants, cardiovascular,
p.(None): to carry neurological and orthopedic implants.
p.(None): (2) The following data categories can be processed in the registers:
p.(None): 1. patient identification (year of birth, gender, area-specific personal identifier),
p.(None): 2. Data about the implanting healthcare facility, in particular for its identification,
p.(None): 3. relevant clinical data on medical history, current state of health and indication,
p.(None): 4. technical, clinical, organizational and temporal data on the care process,
p.(None): 5. Data for the measurement of results (outcome),
p.(None): 6. Technical data on the implant, speci fi c implant parameters, data on the individual
p.(None): Implant setting, and
p.(None): 7. Technical, clinical, organizational, temporal and event-related data for aftercare.
p.(None): (3) The implanting / treating institutions of the healthcare system are, if this is the
p.(None): Protection of the health and safety of patients is required, the obligations mentioned in paragraph 2 and
p.(None): Personal Austria data required for the purposes of keeping the register
p.(None): to be submitted online. The granting of access to health care facilities is
p.(None): clearly documented by Gesundheit Österreich GmbH.
p.(None): (4) The Federal Minister for Health, Family and Youth has set up implant registers
p.(None): and to specify the speci fi c data sets for the individual registers by ordinance. In this
p.(None): Regulation are also the specific processing purposes and the respective processing purpose
p.(None): to set appropriate access rights.
p.(None): (5) Personal data must be pseudonymized immediately. When processing data according to
p.(None): Paragraphs 1 and 2 are for patient identification only the use of the area-speci fi c
p.(None): Personal identifier GH and AS (Section 10 Paragraph 2 E-Government Act, Federal Law Gazette I № 10/2004) permitted. The
p.(None): Area-specific personal identifiers AS may only be used and saved in encrypted form
p.(None): become. The direct personal reference must be irreversibly deleted immediately after conversion.
p.(None): (6) The area-specific personal identifiers are to be deleted as soon as they are used for the purposes
p.(None): Paragraph 1 are no longer required. The Federal Statistics Austria has health Austria
p.(None): GmbH - at their request - personal data on the time of death and the cause of death of
p.(None): To transmit persons whose data are stored in an implant register in accordance with paragraph 1.
p.(None): (Note: Paragraph 7 repealed by Art. 47 Z 29, Federal Law Gazette I No. 37/2018)
p.(None): (8) The managing director of Gesundheit Österreich GmbH has to ensure that the clear
p.(None): Identity and role of those authorized to access the state of the art for each access
p.(None): be proven and recorded. He must ensure that the appropriate state of the art
p.(None): Technically appropriate precautions are taken in order to destroy or change the data
...
p.(None): (12) The managing director of Gesundheit Österreich GmbH is obliged to have access authorization for
p.(None): assign the individual users of Gesundheit Österreich GmbH individually. The authorized users of the
p.(None): Gesundheit Österreich GmbH are aware of the provisions of the General Data Protection Regulation and that
p.(None): To teach data security concept. These access rights are deprived of their access rights,
p.(None): if they no longer need them for the further fulfillment of the tasks assigned to them or they
p.(None): Do not process data in accordance with its intended purpose.
p.(None): (13) The managing director of Gesundheit Österreich GmbH has through organizational and technical
p.(None): Precautions to ensure that access to rooms in which the database server is located
p.(None): In principle, only those with access to access from Health Austria GmbH are possible.
p.(None): (14) If the database server is removed from the area of Gesundheit Österreich GmbH, the
p.(None): Managing Director of Gesundheit Österreich GmbH ensure that unauthorized use
p.(None): is excluded.
p.(None): (15) The marketers of implants that are kept in registers according to paragraph 1 are
p.(None): undertakes to provide the technical data of your health implants required for the purposes of the register
p.(None): Österreich GmbH in electronic form.
p.(None): Traceability of medical devices
p.(None): Section 73b. The Federal Minister of Health, Family and Youth, insofar as this is in view of the
p.(None): Protect the health and safety of patients, users or third parties and avert risks
p.(None): is required considering types, groups or classes of medical devices with increased
p.(None): Risk potential through regulation for those responsible for placing medical devices on the market and
p.(None): Health care institutions for appropriate preventive measures and measures with regard to the
p.(None): Commit to traceability of medical devices while making determinations about
p.(None): 1. The types, groups or classes of medical devices that depend on the requirements of the
p.(None): Traceability are captured
p.(None): 2. the product- or product group-specific requirements regarding traceability as well
p.(None): with regard to the type, content, specificity and availability of the necessary records,
p.(None): and
p.(None): 3. the way of setting up suitable implant registers in facilities of the
p.(None): Healthcare and the necessary records.
p.(None): observational
p.(None): Section 74. The Federal Minister of Health and Consumer Protection may consider
p.(None): serious interests of public health and with a view to gaining improved
p.(None): Knowledge about the benefit / risk assessment of certain types or groups of medical devices,
p.(None): in particular also about the long-term effects of implantable medical devices that can only be
p.(None): systematic data collection and evaluation can be obtained, prescribe by regulation,
p.(None): that relevant data that has been collected in connection with the use of these medical devices and
...
p.(None): Measurement and calibration law covers measurement functions of medical devices and commercial law
p.(None): Provisions are concerned, and with regard to § 99 paragraph 1, as far as commercial law concerns
p.(None): are concerned, the Federal Minister of Health and Consumer Protection in agreement with the
p.(None): Federal Minister for Economic Affairs and
p.(None): 4. with regard to Section 98 (1) of the Federal Minister of Health and Consumer Protection in
p.(None): Agreement with the Federal Minister for Economic Affairs
p.(None): entrusted.
p.(None): (2) Before enacting ordinances in accordance with this federal law, those responsible pursuant to para
p.(None): Federal Minister to hear an advisory council, which, in addition to experts in the field of regulation
p.(None): In any case, a representative of the Federal Ministry of Economics and Labor, the
p.(None): Federal Ministry of Social Affairs and Consumer Protection, the Austrian Medical Association, the
p.(None): Austrian Chamber of Dentists, the Federal Chamber of Labor, the Austrian Chamber of Commerce, the
p.(None): Austrian Chamber of Pharmacists, the main association of Austrian social security institutions, the
p.(None): Austrian Agency for Health and Nutritional Security GmbH, business unit PharmMed, and
p.(None): belong to the Austrian Seniors' Council. Furthermore, they are according to the state law
p.(None): Implementing provisions for § 11e of the Federal Act on Hospitals and Health Centers (KAKuG)
p.(None): existing patient representative bodies are entitled to send a representative.
p.(None): (3) The advisory board according to paragraph 2 is chaired by an employee of the Federal Ministry of Health,
p.(None): Family and youth, the work of the Advisory Board is carried out by the Federal Minister of Health, Family
p.(None): and youth led to rules of procedure to be adopted. In any case, it should be provided in this case
p.(None): the advisory board may be referred to in a circular manner with particular urgency or less importance.
...
Health / Physically Disabled
Searching for indicator illness:
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p.(None): has been demonstrably granted, and it is ensured that the expressly by a minor
p.(None): expressed desire not to take the clinical trial or take it at any time
p.(None): to be considered by the clinical investigator
p.(None): 6. The consent can be withdrawn at any time without the minor being affected
p.(None): Disadvantage arises
p.(None): 7. with the participation in the clinical trial, no incentives or financial benefits
p.(None): Exception to an expense allowance,
p.(None): 8. the clinical trial is planned so that it takes into account the disease and the
p.(None): Developmental stage of the minor with as little pain, discomfort, fear and
p.(None): other predictable risks, including the risk threshold as well as the
p.(None): Degree of exposure specifically defined and constantly checked,
p.(None): 9. The test plan by an ethics committee that has knowledge in the field of children and
p.(None): Juvenile medicine or who deals with clinical, ethical and psychosocial issues on the
p.(None): Had been advised in the area of pediatrics and adolescent medicine, and was approved
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of
p.(None): Science stand.
p.(None): (2) Deviating from Paragraph 1 No. 2, a clinical trial on minors is also permitted if
p.(None): 1. The clinical trial is an essential extension of the scientific understanding of the
p.(None): Condition, illness or disorder of the minor and thereby either
p.(None): Can benefit patients or the patient group to which the minor belongs, and
p.(None): 2. The clinical trial for the minor with only a minimal risk and minimal burden
p.(None): brings oneself; a clinical trial has minimal risk and minimal burden if
p.(None): it is to be expected that at most it will be a minor and merely temporary
p.(None): Impairment and any symptoms or inconveniences can be very minor
p.(None): and will only appear temporarily.
p.(None): § 52. The clinical trial may be carried out on a person who is the result of a mental illness or a
p.(None): comparable impairment of their ability to make decisions has a legal representative or on
p.(None): judicial or official order stopped or according to the Housing Act, BGBl.
p.(None): No. 155/1990, is not carried out.
p.(None): Section 52a. (1) A clinical trial, by its nature, can only be used in emergency situations in which appropriate
p.(None): Time no consent of the legal representative can be obtained, can be carried out at
p.(None): a person who is unable to consent to have a clinical trial performed if:
p.(None): 1. There are no indications that either the patient refused the clinical trial
p.(None): or would reject or the requirements of Section 52 exist,
p.(None): 2. Such research for the validation of data used in clinical trials for consent
p.(None): have been obtained by persons capable of providing information or using other research methods, and
p.(None): absolutely necessary for the clinical evaluation of the safety and effectiveness of the medical device
p.(None): are and can only be carried out in emergency situations,
p.(None): 3. the medical device that is being tested to fulfill a purpose as defined in Section 2 (1)
p.(None): Z 1 to 3 is determined in an emergency situation,
p.(None): 4. the use of the medical device that is being tested according to the knowledge of the medical
p.(None): Science is indicated to help the emergency patient
p.(None): a) to recognize, prevent, monitor, treat or alleviate an illness,
p.(None): b) identify, monitor, treat, alleviate, or alleviate an injury or disability
p.(None): compensate, or
p.(None): c) to examine, change or adapt the anatomical structure or physiological processes
p.(None): replace,
p.(None): and the patient benefit associated with inclusion in the clinical trial, the risk
p.(None): predominates
p.(None): 5. the conduct of the test and the test plan by an ethics committee that has knowledge of the
p.(None): Area of the disease concerned, in relation to the emergency situation and the affected
p.(None): Patient group or who deal with clinical and ethical issues in the field of
p.(None): related illness, in relation to the emergency situation and the affected patient group
p.(None): , expressly for the conduct of clinical trials in emergency situations on persons who
p.(None): are unable to give personal consent, have been approved, and
p.(None): 6. In case of doubt, the interests of the patient always outweigh the public interests and the interests of the patient
p.(None): Science stand.
p.(None): (2) At the test center where a clinical trial in emergency situations is performed on people who are not in
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 49 and
p.(None): 50 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Enlightenment including express consent under data protection law is given. Another
p.(None): Processing of the data processed up to that point requires the express data protection law
p.(None): Approval.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
...
p.(None): awaken that these objects are themselves medical devices or have one of a medical device
p.(None): corresponding mechanism of action.
p.(None): Section 103. Information on the intended purpose in advertising materials may be used for labeling and
p.(None): Do not contradict the instructions for use and no information regarding an additional purpose
p.(None): contain.
p.(None): lay Advertising
p.(None): Section 104. Advertising intended for consumers may not be used for
p.(None): 1.medical devices that are subject to a prescription requirement according to an ordinance according to § 100,
p.(None): 2. Medical devices that are exclusively intended for healthcare professionals on or for
p.(None): to be applied to the patient, or
p.(None): 3. Medical devices, their use by consumers based on the instructions for use only in
p.(None): In connection with medical or dental treatment or surveillance
p.(None): may,
p.(None): operate.
p.(None): Section 105. Medical device advertising intended for consumers must be designed in such a way that the
p.(None): Advertising character is clearly expressed and the product is clearly represented as a medical device.
p.(None): Section 106. Medical device advertising intended for consumers may not contain any elements that
p.(None): 1. suggest that the effect corresponds to another treatment or another medical device
p.(None): or is superior
p.(None): 2. are intended exclusively or mainly for children,
p.(None): 3. Make medical treatment seem superfluous, especially by making it one
p.(None): mislead self-diagnosis, or treatment by correspondence
p.(None): recommend,
p.(None): 4. Abusive, worrying or misleading
p.(None): Get recovery certificates,
p.(None): 5. Abusive, worrying or misleading representations of the
p.(None): Changes in the human body due to illness, injury or
p.(None): Disabilities or the effect of a medical device on or in the human body
p.(None): use.
p.(None): Section 107. (1) Medical device advertising intended for consumers has at least the following information
p.(None): to contain:
p.(None): 1. the name of the medical device,
p.(None): 2. the intended use of the medical device,
p.(None): 3. the information essential for the sensible use of the medical device,
p.(None): 4. A clearly perceptible indication if the medical device is also undesirable
p.(None): May cause effects or its use requires special safety precautions.
p.(None): (2) Medical device advertising, which is intended for consumers, has a reference to this if applicable
p.(None): to include that the instructions for use be followed carefully and, if necessary, the advice of a doctor,
p.(None): Dentists, dentists, pharmacists or any other, due to their professional training
p.(None): authorized person. If advertising is carried out via acoustic or audiovisual media, this must be done
p.(None): Notice to be clearly audible acoustically.
p.(None): professional advertising
p.(None): Section 108. In the context of sales promotion for medical devices among the persons to whom under the
p.(None): Prescription, dispensing, procurement for health care facilities, construction, commissioning
p.(None): or application tasks, it is prohibited to give them a premium, fi nancial or material
p.(None): To grant, offer or promise benefits unless they are of little value and to those
p.(None): medical or medical practice of concern. The people who in connection with the
p.(None): Prescription, dispensing, procurement for health care facilities, construction, commissioning
p.(None): or application of medical device tasks, it is prohibited to make a premium, fi nancial or
p.(None): to demand material advantages, to be promised or to accept.
...
Searching for indicator physically:
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p.(None): Section 3
p.(None): costs
p.(None): Section 111b. (1) The Federal Minister of Health and Women, in agreement with the
p.(None): Federal Minister of Finance Fees for those to be carried out under this Federal Act
p.(None): Official acts and activities of federal agencies, the necessity of which derives from this
p.(None): Federal law and the regulations or relevant legal acts of the
p.(None): European Union results, set in one tariff. Fees for reports can also be included in the tariff
p.(None): Section 67 and for reports in connection with implant registers in accordance with an ordinance pursuant to Section 73
p.(None): be determined.
p.(None): (2) When determining the chargeable facts, on the one hand, experience has shown that in the
p.(None): Average costs incurred, on the other hand on the importance or the benefit for the
p.(None): To take due account of fee debtors. The tariff and its changes are in the “Official Journal
p.(None): to the Wiener Zeitung ”.
p.(None): (3) Is the result of this federal law, the regulations issued on the basis thereof
p.(None): or legal acts of the European Union the need for official acts or activities of
p.(None): Federal agencies for which a tariff has not been set are the actual costs incurred
p.(None): prescribe.
p.(None): (4) For cash expenses, the party, regardless of the fees set in the tariff in accordance with § 76 of the
p.(None): General Administrative Procedure Act 1991, Federal Law Gazette No. 51.
p.(None): Section 4
p.(None): Final and transitional provisions
p.(None): § 112. (1) Medical devices within the meaning of Directive 93/42 / EEC, which are physically available as individual
p.(None): Products conforming to the regulations in force on December 31, 1994 before June 15
p.(None): Were placed on the market in Austria in 1998, and
p.(None): 1. which are safe and efficient,
p.(None): 2. whose expiry date has not passed and
p.(None): 3. which do not have to be installed or assembled by the end user,
p.(None): may still be put into operation during a transition period until June 30, 2001, unless
p.(None): the requirements according to § 8 are not fulfilled or measures according to § 77 are taken.
p.(None): (2) Medical devices for in vitro diagnosis, which are valid in Austria on December 7, 1998
p.(None): existing regulations, may continue until December 6, 2003 in Austria
p.(None): To be placed on the market. In vitro diagnostic medical devices placed on the market in this way may be used until the end of the
p.(None): Placed on the market or put into service in Austria on 6 December 2005, unless
p.(None): the requirements according to §§ 8, 9 and 11 are not met or measures according to § 77 are taken.
p.(None): There are changes to these regulations for the purpose of protecting human beings from one
p.(None): apply direct or indirect health hazards.
p.(None): (3) The Federal Minister of Health and Consumer Protection has, provided this with regard to the
p.(None): Protect the health and safety of patients, users or third parties and protect them significantly
p.(None): Risks is required through regulation conformity assessment procedures for medical devices for which the
p.(None): Transitional regulation of paragraph 1 applies as a prerequisite for placing on the market and commissioning
p.(None): to prescribe and specify their type. Content and implementation.
...
Health / Pregnant
Searching for indicator pregnant:
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p.(None): 6. In case of doubt, the interests of the patient always outweigh the public interests and the interests of the patient
p.(None): Science stand.
p.(None): (2) At the test center where a clinical trial in emergency situations is performed on people who are not in
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 49 and
p.(None): 50 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Enlightenment including express consent under data protection law is given. Another
p.(None): Processing of the data processed up to that point requires the express data protection law
p.(None): Approval.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 51.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 53. The clinical trial of a medical device may be carried out on a pregnant or breastfeeding woman
p.(None): Mother can only be done when
p.(None): 1. the medical device to be tested in order to achieve a purpose in accordance with Section 2 (1)
p.(None): breastfeeding mothers, pregnant women or unborn children
p.(None): 2. the use of the medical device according to the knowledge of the medical sciences
p.(None): is indicated to the breastfeeding mother or pregnant woman taking the clinical trial
p.(None): is carried out, or in the case of her unborn child a purpose in accordance with Section 2 (1)
p.(None): to reach,
p.(None): 3. according to the knowledge of the medical sciences, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn or breastfed child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): or breastfeeding mothers can expect adequate test results.
p.(None): § 54. The clinical trial of a medical device may be carried out on persons who have a presence or
p.(None): Provide training or community service, not be carried out.
p.(None): Dealing with data
p.(None): Section 55. (1) During the entire course of the clinical trial, everyone involved is
p.(None): treat patient-related data with strict confidentiality. All patient-related data must be against
p.(None): unauthorized access is protected and pseudonymized as far as possible, whereby it must be ensured that
p.(None): that the additional information with which the personal data of an affected person
p.(None): can be assigned to be kept separately.
p.(None): (2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and
p.(None): set confidential handling of all data resulting from a clinical trial.
p.(None): (3) The study plan, the final report as well as all created in connection with the clinical study
p.(None): Data and documents are for specific periods after the completion or termination of the clinical trial
p.(None): to be kept by the Federal Minister of Health and Consumer Protection in a regulation pursuant to
p.(None): Section 66 are to be laid down. This regulation also specifies who is to be kept for certain
p.(None): Data or documents hits.
p.(None): (3a) For the period of the retention periods, the right under Art. 17 data protection
p.(None): Basic regulation excluded.
...
Health / breastfeeding
Searching for indicator breastfeeding:
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p.(None): Science stand.
p.(None): (2) At the test center where a clinical trial in emergency situations is performed on people who are not in
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 49 and
p.(None): 50 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Enlightenment including express consent under data protection law is given. Another
p.(None): Processing of the data processed up to that point requires the express data protection law
p.(None): Approval.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 51.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 53. The clinical trial of a medical device may be carried out on a pregnant or breastfeeding woman
p.(None): Mother can only be done when
p.(None): 1. the medical device to be tested in order to achieve a purpose in accordance with Section 2 (1)
p.(None): breastfeeding mothers, pregnant women or unborn children
p.(None): 2. the use of the medical device according to the knowledge of the medical sciences
p.(None): is indicated to the breastfeeding mother or pregnant woman taking the clinical trial
p.(None): is carried out, or in the case of her unborn child a purpose in accordance with Section 2 (1)
p.(None): to reach,
p.(None): 3. according to the knowledge of the medical sciences, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn or breastfed child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): or breastfeeding mothers can expect adequate test results.
p.(None): § 54. The clinical trial of a medical device may be carried out on persons who have a presence or
p.(None): Provide training or community service, not be carried out.
p.(None): Dealing with data
p.(None): Section 55. (1) During the entire course of the clinical trial, everyone involved is
p.(None): treat patient-related data with strict confidentiality. All patient-related data must be against
p.(None): unauthorized access is protected and pseudonymized as far as possible, whereby it must be ensured that
p.(None): that the additional information with which the personal data of an affected person
p.(None): can be assigned to be kept separately.
p.(None): (2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and
p.(None): set confidential handling of all data resulting from a clinical trial.
p.(None): (3) The study plan, the final report as well as all created in connection with the clinical study
p.(None): Data and documents are for specific periods after the completion or termination of the clinical trial
p.(None): to be kept by the Federal Minister of Health and Consumer Protection in a regulation pursuant to
p.(None): Section 66 are to be laid down. This regulation also specifies who is to be kept for certain
p.(None): Data or documents hits.
p.(None): (3a) For the period of the retention periods, the right under Art. 17 data protection
p.(None): Basic regulation excluded.
p.(None): (4) All data and documents relevant to the clinical trial must be submitted to the
p.(None): Federal Office for Safety in Health Care to check compliance with the provisions of this
...
Health / patients in emergency situations
Searching for indicator emergency situation:
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p.(None): and will only appear temporarily.
p.(None): § 52. The clinical trial may be carried out on a person who is the result of a mental illness or a
p.(None): comparable impairment of their ability to make decisions has a legal representative or on
p.(None): judicial or official order stopped or according to the Housing Act, BGBl.
p.(None): No. 155/1990, is not carried out.
p.(None): Section 52a. (1) A clinical trial, by its nature, can only be used in emergency situations in which appropriate
p.(None): Time no consent of the legal representative can be obtained, can be carried out at
p.(None): a person who is unable to consent to have a clinical trial performed if:
p.(None): 1. There are no indications that either the patient refused the clinical trial
p.(None): or would reject or the requirements of Section 52 exist,
p.(None): 2. Such research for the validation of data used in clinical trials for consent
p.(None): have been obtained by persons capable of providing information or using other research methods, and
p.(None): absolutely necessary for the clinical evaluation of the safety and effectiveness of the medical device
p.(None): are and can only be carried out in emergency situations,
p.(None): 3. the medical device that is being tested to fulfill a purpose as defined in Section 2 (1)
p.(None): Z 1 to 3 is determined in an emergency situation,
p.(None): 4. the use of the medical device that is being tested according to the knowledge of the medical
p.(None): Science is indicated to help the emergency patient
p.(None): a) to recognize, prevent, monitor, treat or alleviate an illness,
p.(None): b) identify, monitor, treat, alleviate, or alleviate an injury or disability
p.(None): compensate, or
p.(None): c) to examine, change or adapt the anatomical structure or physiological processes
p.(None): replace,
p.(None): and the patient benefit associated with inclusion in the clinical trial, the risk
p.(None): predominates
p.(None): 5. the conduct of the test and the test plan by an ethics committee that has knowledge of the
p.(None): Area of the disease concerned, in relation to the emergency situation and the affected
p.(None): Patient group or who deal with clinical and ethical issues in the field of
p.(None): related illness, in relation to the emergency situation and the affected patient group
p.(None): , expressly for the conduct of clinical trials in emergency situations on persons who
p.(None): are unable to give personal consent, have been approved, and
p.(None): 6. In case of doubt, the interests of the patient always outweigh the public interests and the interests of the patient
p.(None): Science stand.
p.(None): (2) At the test center where a clinical trial in emergency situations is performed on people who are not in
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 49 and
p.(None): 50 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Enlightenment including express consent under data protection law is given. Another
p.(None): Processing of the data processed up to that point requires the express data protection law
p.(None): Approval.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 51.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 53. The clinical trial of a medical device may be carried out on a pregnant or breastfeeding woman
p.(None): Mother can only be done when
p.(None): 1. the medical device to be tested in order to achieve a purpose in accordance with Section 2 (1)
p.(None): breastfeeding mothers, pregnant women or unborn children
p.(None): 2. the use of the medical device according to the knowledge of the medical sciences
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): Agreement on the European Economic Area and the European Commission on designations
p.(None): in accordance with paragraph 2 and about the revocation or the restriction of a designation in accordance with paragraph 4 in
p.(None): To put knowledge.
p.(None): Minimum criteria for notified bodies
p.(None): Section 37. (1) The notified body, its manager and that by carrying out the assessments and tests
p.(None): Commissioned personnel must be independent of the body responsible for the medical device to be assessed
p.(None): has developed or constructed, as well as by its manufacturer, distributor, installer or user. they may
p.(None): neither directly nor as an agent for the development or construction, the manufacture, the sales
p.(None): or be involved in the maintenance of these products for the applicant. The possibility of one
p.(None): This does not result in the exchange of technical information between the manufacturer and the notified body
p.(None): locked out.
p.(None): (2) The notified body must be capable of all in accordance with a conformity assessment procedure
p.(None): a regulation provided for in § 28 tasks which are assigned to such a position and for which
p.(None): it is designated to perceive, be it that these tasks are performed by the notified body itself or be it that it
p.(None): are carried out in some areas under their responsibility. You must in particular about the staff
p.(None): dispose of and possess the means necessary to carry out the implementation of the assessments and examinations
p.(None): associated medical-scientific, technical and administrative tasks required
p.(None): are. You must have the equipment necessary for the tests and surveillance
p.(None): however, in some areas operate external facilities if access to them is regulated and their
p.(None): Suitability is ensured.
p.(None): (3) The body and the personnel responsible for the examination must include the evaluations and examinations
p.(None): carry out the required expertise and reliability in the field of medical devices and
p.(None): regardless of any possible influence, especially of a financial nature, on their assessment or the
p.(None): Be the results of their test.
p.(None): (4) If a Notified Body determined after establishing the agreement with the client
p.(None): If it submits work related to the conformity assessment to a subcontractor
p.(None): ensure beforehand that the provisions of this section are observed by the subcontractor.
p.(None): The notified body has the relevant documents to assess the technical competence of the
p.(None): Subcontractor and on the work carried out by the latter within the framework of this Federal Act on
p.(None): To be available for inspection by the responsible authorities.
p.(None): (5) Only parts of conformity assessment procedures to be subcontracted may be smaller
p.(None): Make up part of the total order. Overall responsibility for carrying out a
p.(None): The notified body must in any case carry out the conformity assessment procedure.
p.(None): (6) The personnel responsible for the examinations must meet the following requirements:
p.(None): 1. the necessary basis for the assessments and tests for which the position has been designated
p.(None): Qualification,
p.(None): 2. Adequate knowledge of the regulations for the tests carried out by him and a
p.(None): sufficient practical experience in this area and
p.(None): 3. those for carrying out the tests and drafting the certificates, protocols and
p.(None): Reports, in which the tests carried out are recorded, suitability required.
...
p.(None): 2. the use of the medical device according to the knowledge of the medical sciences
p.(None): is indicated to the breastfeeding mother or pregnant woman taking the clinical trial
p.(None): is carried out, or in the case of her unborn child a purpose in accordance with Section 2 (1)
p.(None): to reach,
p.(None): 3. according to the knowledge of the medical sciences, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn or breastfed child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): or breastfeeding mothers can expect adequate test results.
p.(None): § 54. The clinical trial of a medical device may be carried out on persons who have a presence or
p.(None): Provide training or community service, not be carried out.
p.(None): Dealing with data
p.(None): Section 55. (1) During the entire course of the clinical trial, everyone involved is
p.(None): treat patient-related data with strict confidentiality. All patient-related data must be against
p.(None): unauthorized access is protected and pseudonymized as far as possible, whereby it must be ensured that
p.(None): that the additional information with which the personal data of an affected person
p.(None): can be assigned to be kept separately.
p.(None): (2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and
p.(None): set confidential handling of all data resulting from a clinical trial.
p.(None): (3) The study plan, the final report as well as all created in connection with the clinical study
p.(None): Data and documents are for specific periods after the completion or termination of the clinical trial
p.(None): to be kept by the Federal Minister of Health and Consumer Protection in a regulation pursuant to
p.(None): Section 66 are to be laid down. This regulation also specifies who is to be kept for certain
p.(None): Data or documents hits.
p.(None): (3a) For the period of the retention periods, the right under Art. 17 data protection
p.(None): Basic regulation excluded.
p.(None): (4) All data and documents relevant to the clinical trial must be submitted to the
p.(None): Federal Office for Safety in Health Care to check compliance with the provisions of this
p.(None): Federal Act on Clinical Trials will be made available.
p.(None): Quality control and quality management
p.(None): § 56. (1) The sponsor and the clinical investigator have with regard to planning, implementation and
p.(None): Evaluation of a clinical trial to apply an adequate quality management system that the
p.(None): complete traceability of all observations and findings, correct collection and processing
p.(None): data and the correct derivation of conclusions.
p.(None): (2) An audit initiated by the sponsor must be carried out by bodies or organizational units that
...
p.(None): and compared to available medical devices that are already permitted on the market
p.(None): seriously increases the chances of success,
p.(None): 2. the social security institution or third parties information about the medical device used and
p.(None): the clinical trial has been made available and
p.(None): 3. Social insurance institutions or third parties based on these documents after assessing the existence
p.(None): have agreed to the requirements of sections 1 and 2 of an application for cost coverage.
p.(None): (5) The sponsor must assess the test plan and confirm it with his signature.
p.(None): (6) The sponsor may carry out its duties or obligations in whole or in part
p.(None): delegate to external scientific institutions.
p.(None): Tasks and responsibilities of the clinical investigator
p.(None): § 64. (1) Clinical investigator may only be a suitably qualified, for independent practice of
p.(None): medical or dental profession in Austria may be a qualified doctor or dentist who
p.(None): 1. is trained and experienced in the area of application of the medical device to be tested and
p.(None): 2. is familiar with the background and requirements of the clinical trial and at least one
p.(None): can demonstrate two years of experience in clinical trials.
p.(None): (2) Before the start of the clinical trial, the clinical investigator must have all relevant data and
p.(None): Documents, in particular with regard to the test plan, the relevant scientific literature, the
p.(None): preclinical data, the results of previous clinical trials with the medical device, the evidence
p.(None): about technical security, the documents about structure, composition, functionality,
p.(None): Properties and performance of the medical device and the instructions for its intended use
p.(None): Familiarize application thoroughly. The sponsor has access to all of the clinical investigator
p.(None): to ensure relevant data.
p.(None): (3) The clinical investigator must ensure that he and his employees also with regard to the
p.(None): Human resources and the available facilities and medical facilities in
p.(None): are able to conduct the clinical trial in accordance with this federal law and the trial plan and
p.(None): complete. This also includes arrangements for emergency measures.
p.(None): (4) The clinical investigator is responsible for the clarification and information required by this Federal Act
p.(None): the test participant and, if applicable, their legal representatives and obtaining the necessary
p.(None): Responsible consent.
p.(None): (4a) The clinical investigator has for the sponsor the obligations under Art. 13, 15, 16 and 18 of the data protection
p.(None): To comply with the basic regulation and in the event of violations of the protection of personal data
p.(None): Notify test takers in accordance with Art. 34 of the General Data Protection Regulation and the sponsor
p.(None): to inform about it.
p.(None): (5) The clinical investigator has the sponsor about all medical device side effects and all
p.(None): to report serious adverse events as part of the clinical trial.
p.(None): (6) The clinical investigator must sign the test plan and in writing and with his signature
p.(None): confirm that he is conducting the clinical trial in accordance with the study plan and the provisions of this
p.(None): Federal law will implement.
...
p.(None): to report the availability via telecommunication facilities. When designating the
p.(None): Medical devices in the regulation according to paragraph 7 is of considerable risk potential
p.(None): Medical devices and the requirement of prompt information from these facilities in the cases of Section 77
p.(None): as well as to take into account regulations in accordance with sections 95 and 96.
p.(None): (5) Subsequent changes to the data in accordance with paragraphs 1 to 4 must be reported immediately.
p.(None): (6) The Federal Minister of Health and Consumer Protection shall inform the other contracting parties
p.(None): of the Agreement on the European Economic Area and the European Commission on their
p.(None): Inquiry as well as by means of a common European data network about the reports according to
p.(None): paragraphs 1, 2 and 5.
p.(None): (7) The Federal Minister of Health may consider the consistency of the reports
p.(None): and on the information required for medical device monitoring by ordinance Art. Content,
p.(None): Specify the form and procedure of the reports in accordance with paragraphs 1 to 5. With active implantable
p.(None): Medical devices, for medical devices of classes IIa, IIb and III of directive 93/42 / EEC and for in vitro
p.(None): Diagnostics in Appendix II and in-vitro diagnostics for self-application of Directive 98/79 / EC can be obtained from
p.(None): Federal Minister of Health communicating all information that identifies the medical device
p.(None): enable as well as the labeling and instructions for use if these medical devices
p.(None): be put into operation within the scope of this federal law. The Federal Minister for
p.(None): Health can also regulate the reporting obligations, modalities and access authorizations in this regulation
p.(None): With regard to the European database as defined by Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC
p.(None): establish.
p.(None): Section 2
p.(None): monitoring
p.(None): Section 68. (1) Companies, facilities or persons who work professionally or commercially with medical devices
p.(None): bypass, in particular manufacture, test, store, transport, pack, exhibit, in
p.(None): Bring traffic or put it together within the meaning of Section 33 (1), the medical devices professionally or
p.(None): professionally maintain, convert, assemble, adapt or process the medical devices professionally
p.(None): or professionally clean, disinfect or sterilize or medical devices in facilities of the
p.(None): With regard to these activities, the application or operation of health care is subject to
p.(None): Monitoring.
p.(None): (2) Monitoring within the meaning of paragraph 1 is carried out by the organs of the Federal Office for Security in the
p.(None): Healthcare, the Federal Minister of Health and Women or by commissioned by them
p.(None): Expert. The activity of relevant accredited bodies, from
p.(None): Federal Minister of Health and Women recognized organizer of proficiency tests, by operators of
p.(None): Medical device registries or other organizers from the Federal Minister of Health and Women
p.(None): recognized cross-regional comparative tests and assessments related to
p.(None): Medical devices.
p.(None): (3) Insofar as within the scope of conformity assessment procedures according to a regulation according to § 28
p.(None): Monitoring is provided, it is carried out by the for the respective conformity assessment procedure
...
p.(None): to ward off risks associated with pacemaker implants,
p.(None): implantable defibrillators and loop recorders,
p.(None): 2. for the purpose of medical device vigilance and market surveillance related
p.(None): Pacemakers, implantable defibrillators and loop recorders,
p.(None): 3. for the purpose of quality-assured treatment in connection with the corresponding
p.(None): implantations
p.(None): 4. for the purpose of quality assurance of pacemakers, implantable defibrillators and loop devices
p.(None): recorders,
p.(None): 5. for the purpose of statistics as a basis for planning, quality assurance and quality reporting
p.(None): in Austrian healthcare and
p.(None): 6. for scientific purposes
p.(None): maintain a register for pacemakers, implantable defibrillators and loop recorders. The
p.(None): Gesundheit Österreich GmbH is responsible for the register.
p.(None): (2) The following data categories are processed in the register:
p.(None): 1. Data on the implanting / treating healthcare facility (name of the
p.(None): implanting / treating institution or name of the treating doctor,
p.(None): Hospital number, contact details),
p.(None): 2. Data on patient identification (name, gender, date of birth, social security number,
p.(None): Contact details, area-specific personal identifier),
p.(None): 3. if applicable, death data (date, cause of death, autopsy status),
p.(None): 4. relevant clinical data on medical history, current state of health and indication
p.(None): (Pre-intervention, symptoms, etiology, preoperative cardiac rhythm),
p.(None): 5. Technical, clinical, organizational and temporal data on the care process (surgeon,
p.(None): Implantation data of the medical devices and the associated probes, date of implantation,
p.(None): Localization of medical devices, access, secondary prophylaxis),
p.(None): 6. Technical data on the implant, speci fi c implant parameters, data on the individual
p.(None): Implant setting (model, manufacturer and serial number of the medical devices and the
p.(None): associated probes, implant parameters), and
p.(None): 7. Technical, clinical, organizational, time and event-related data for aftercare
p.(None): (technical and clinical control data of the implanted medical devices and the associated
p.(None): Probes, functional status, date and indication of the control, complications, explant date,
p.(None): Explantationsgrund).
p.(None): (3) The implanting / treating health facilities are in accordance with paragraph 4
p.(None): obligates the personal data types of Gesundheit Österreich GmbH mentioned in paragraph 2 online
p.(None): to transmit.
p.(None): (4) The transmission according to paragraph 3 is only permitted if the data subjects
p.(None): 1. About processing for the purposes of the pacemaker, ICD, or loop recorder register
p.(None): have been informed and
p.(None): 2. have expressly consented to this processing.
p.(None): If the consent is withdrawn during a follow-up contact, the person concerned must be informed that
p.(None): that the data for direct personal reference is irreversibly deleted and the remaining data,
p.(None): due to a lack of assignability, can no longer be used for their treatment purposes. Does it exist
p.(None): The person concerned, even after being informed about these consequences by revoking their consent, is the
p.(None): Gesundheit Österreich GmbH to inform you of the revocation. Gesundheit Österreich GmbH has the
p.(None): Pseudonymize data immediately.
p.(None): (4a) If no consent has been given, the implanting or treating
p.(None): health facilities
p.(None): 1. the data in accordance with paragraph 2 items 1 and 3 to 7 and
p.(None): 2. to transmit the area-specific personal identifier health (bPK-GH).
p.(None): Data transmitted on the basis of this paragraph may only be processed for the purposes of paragraph 1 numbers 5 and 6
p.(None): become.
p.(None): (5) The granting of access rights to the pacemaker, ICD and loop recorder
p.(None): Register by health care institutions is through Gesundheit Österreich GmbH
p.(None): documented in a comprehensible manner. When granting access authorizations by institutions of the
p.(None): Health care must ensure that access rights are only granted to the extent that
p.(None): this is specifically necessary for a purpose in accordance with paragraph 1. The granting of access authorization has changed
p.(None): to refer to specific people, their clear identity and scope of health justification
p.(None): Österreich GmbH must be proven.
p.(None): (6) When processing data in accordance with paragraphs 1 and 2, the patient must be used to identify the patient
p.(None): Name and area-speci fi c personal identifier GH and AS (§ 10 para. 2 E Government
p.(None): Law, Federal Law Gazette I № 10/2004) is permitted. The area-speci fi c personal identifier AS may only be in
p.(None): encrypted form can be used and saved. The direct personal reference is from
p.(None): Delete the responsible person immediately, irreversibly, as soon as he does not do so for the purposes of paragraph 1 nos. 1 and 3
p.(None): more is needed.
p.(None): (7) Gesundheit Österreich GmbH is entitled to the Federal Statistical Office Austria
p.(None): Request information on the time of death and the cause of death of persons whose data are in the
p.(None): Registers are processed.
p.(None): (8) The managing director of Gesundheit Österreich GmbH has to ensure that identity and role
p.(None): the person authorized to access with each access is proven according to the state of the art and
p.(None): be logged. He must ensure that the appropriate state-of-the-art technology is used
p.(None): Precautions are taken to prevent the data from being destroyed or changed
p.(None): Prevent program errors (viruses) in order to destroy, change or query the data of the
p.(None): Prevent registers by unauthorized users or systems. Furthermore, he must ensure that everyone
p.(None): processing operations carried out, such as in particular entries, changes, queries and
p.(None): Submissions that are traceable. He has to create a data security concept for the employees
p.(None): Health Austria GmbH is binding.
p.(None): (Note: Paragraphs 9 and 10 repealed by Art. 47 Z 18, Federal Law Gazette I No. 37/2018)
p.(None): (11) Gesundheit Österreich GmbH may apply to those processed or to be processed in the register
p.(None): Data
p.(None): 1. basically only in pseudonymized form,
p.(None): 2. to exercise the rights of the persons concerned in accordance with Chapter 3
p.(None): Basic regulation but also in a directly personal form
p.(None): access. For scientific purposes, Gesundheit Österreich GmbH may only use a pseudonym
p.(None): Access form.
p.(None): (12) The health care institutions participating in the registers may
p.(None): 1. For the purposes of paragraph 1 no. 3, all data relating to this person in the register also in
p.(None): access personal form if this is part of a specific treatment situation of the
p.(None): each person is required
p.(None): a) with the express consent of the data subject, or
p.(None): b) if it is impossible to obtain consent, in the vital interest of those concerned
p.(None): Person, and
p.(None): 2. for scientific purposes (para. 1 no. 6) in pseudonymized form to those processed in the register
p.(None): Access data.
p.(None): (13) The Federal Office for Safety in Health Care is for the purposes of medical device vigilance
p.(None): authorized to access the data processed in the register in personal form, provided that this is in the
p.(None): Individual case to protect the health and safety of patients and to ward off serious risks
p.(None): necessary is. Otherwise, the Federal Office for Safety in Health Care for the purposes of
p.(None): Medical device vigilance and market surveillance and for quality assurance purposes
p.(None): Medical devices are authorized to access the data in the register in an indirectly personal form.
p.(None): (14) The managing director of Gesundheit Österreich GmbH is obliged to have access authorization for
p.(None): assign the individual users of Gesundheit Österreich GmbH individually. The authorized users of the
p.(None): Gesundheit Österreich GmbH are aware of the provisions of the General Data Protection Regulation and that
p.(None): To teach data security concept. These access rights are deprived of their access rights,
p.(None): if they no longer need them for the further fulfillment of the tasks assigned to them or they
p.(None): Do not process data in accordance with its intended purpose.
p.(None): (15) The managing director of Gesundheit Österreich GmbH has through organizational and technical
p.(None): Precautions to ensure that access to rooms in which the database server is located
p.(None): In principle, only those with access to access from Health Austria GmbH are possible.
p.(None): (16) If the database server is removed from the area of Gesundheit Österreich GmbH, the
p.(None): Managing Director of Gesundheit Österreich GmbH ensure that unauthorized use
p.(None): is excluded.
p.(None): (17) The marketers of medical devices that are used in pacemaker, ICD, loop recorder
p.(None): Registers are kept, the technical data required for the purposes of the register are required
p.(None): to provide their implants to Gesundheit Österreich GmbH in electronic form.
p.(None): (Note: Paragraph 18 repealed by Art. 47 Z 24, Federal Law Gazette I No. 37/2018)
p.(None): implant register
p.(None): Section 73a. (1) Gesundheit Österreich GmbH is entitled to
p.(None): 1. for the purpose of protecting the health and safety of patients, users or third parties and
p.(None): to ward off risks from implantable medical devices,
p.(None): 2. for the purpose of medical device vigilance and market surveillance of implantable
p.(None): Medical devices,
p.(None): 3. for the purpose of quality assurance of implantable medical devices,
p.(None): 4. for the purpose of statistics as a basis for planning, quality assurance and quality reporting
p.(None): in Austrian healthcare and
p.(None): 5. for scientific purposes
p.(None): Implant register for active implantable medical devices, soft tissue implants, cardiovascular,
p.(None): to carry neurological and orthopedic implants.
p.(None): (2) The following data categories can be processed in the registers:
p.(None): 1. patient identification (year of birth, gender, area-specific personal identifier),
p.(None): 2. Data about the implanting healthcare facility, in particular for its identification,
p.(None): 3. relevant clinical data on medical history, current state of health and indication,
p.(None): 4. technical, clinical, organizational and temporal data on the care process,
p.(None): 5. Data for the measurement of results (outcome),
p.(None): 6. Technical data on the implant, speci fi c implant parameters, data on the individual
p.(None): Implant setting, and
p.(None): 7. Technical, clinical, organizational, temporal and event-related data for aftercare.
p.(None): (3) The implanting / treating institutions of the healthcare system are, if this is the
p.(None): Protection of the health and safety of patients is required, the obligations mentioned in paragraph 2 and
p.(None): Personal Austria data required for the purposes of keeping the register
p.(None): to be submitted online. The granting of access to health care facilities is
p.(None): clearly documented by Gesundheit Österreich GmbH.
p.(None): (4) The Federal Minister for Health, Family and Youth has set up implant registers
p.(None): and to specify the speci fi c data sets for the individual registers by ordinance. In this
p.(None): Regulation are also the specific processing purposes and the respective processing purpose
p.(None): to set appropriate access rights.
p.(None): (5) Personal data must be pseudonymized immediately. When processing data according to
p.(None): Paragraphs 1 and 2 are for patient identification only the use of the area-speci fi c
p.(None): Personal identifier GH and AS (Section 10 Paragraph 2 E-Government Act, Federal Law Gazette I № 10/2004) permitted. The
p.(None): Area-specific personal identifiers AS may only be used and saved in encrypted form
p.(None): become. The direct personal reference must be irreversibly deleted immediately after conversion.
p.(None): (6) The area-specific personal identifiers are to be deleted as soon as they are used for the purposes
p.(None): Paragraph 1 are no longer required. The Federal Statistics Austria has health Austria
p.(None): GmbH - at their request - personal data on the time of death and the cause of death of
p.(None): To transmit persons whose data are stored in an implant register in accordance with paragraph 1.
p.(None): (Note: Paragraph 7 repealed by Art. 47 Z 29, Federal Law Gazette I No. 37/2018)
p.(None): (8) The managing director of Gesundheit Österreich GmbH has to ensure that the clear
p.(None): Identity and role of those authorized to access the state of the art for each access
p.(None): be proven and recorded. He must ensure that the appropriate state of the art
p.(None): Technically appropriate precautions are taken in order to destroy or change the data
p.(None): prevent program errors (viruses) and to destroy, change or query the
p.(None): Prevent data from the registry from unauthorized users or systems. Furthermore, he has to
p.(None): ensure that all usage processes, such as entries, changes,
p.(None): Queries and transmissions are traceable. He has to create a data security concept for
p.(None): the employee of Gesundheit Österreich GmbH is binding.
p.(None): (9) The healthcare institutions participating in the registers may access data in the
p.(None): Access registers for scientific purposes in pseudonymized form.
p.(None): (10) Any access to the data processed or to be processed in the registers by the
p.(None): Gesundheit Österreich GmbH may only be used for the purposes of paragraph 1.
p.(None): (11) The Federal Office for Safety in Health Care is entitled to the in the registers
p.(None): access processed data in pseudonymized form if this is for the purpose of protecting the
p.(None): Health and safety of patients, for warding off risks and for the purpose of
p.(None): Medical device vigilance and market surveillance is necessary.
p.(None): (12) The managing director of Gesundheit Österreich GmbH is obliged to have access authorization for
p.(None): assign the individual users of Gesundheit Österreich GmbH individually. The authorized users of the
p.(None): Gesundheit Österreich GmbH are aware of the provisions of the General Data Protection Regulation and that
p.(None): To teach data security concept. These access rights are deprived of their access rights,
p.(None): if they no longer need them for the further fulfillment of the tasks assigned to them or they
p.(None): Do not process data in accordance with its intended purpose.
p.(None): (13) The managing director of Gesundheit Österreich GmbH has through organizational and technical
p.(None): Precautions to ensure that access to rooms in which the database server is located
p.(None): In principle, only those with access to access from Health Austria GmbH are possible.
p.(None): (14) If the database server is removed from the area of Gesundheit Österreich GmbH, the
p.(None): Managing Director of Gesundheit Österreich GmbH ensure that unauthorized use
p.(None): is excluded.
p.(None): (15) The marketers of implants that are kept in registers according to paragraph 1 are
p.(None): undertakes to provide the technical data of your health implants required for the purposes of the register
p.(None): Österreich GmbH in electronic form.
p.(None): Traceability of medical devices
p.(None): Section 73b. The Federal Minister of Health, Family and Youth, insofar as this is in view of the
p.(None): Protect the health and safety of patients, users or third parties and avert risks
p.(None): is required considering types, groups or classes of medical devices with increased
p.(None): Risk potential through regulation for those responsible for placing medical devices on the market and
p.(None): Health care institutions for appropriate preventive measures and measures with regard to the
p.(None): Commit to traceability of medical devices while making determinations about
p.(None): 1. The types, groups or classes of medical devices that depend on the requirements of the
p.(None): Traceability are captured
p.(None): 2. the product- or product group-specific requirements regarding traceability as well
p.(None): with regard to the type, content, specificity and availability of the necessary records,
p.(None): and
p.(None): 3. the way of setting up suitable implant registers in facilities of the
p.(None): Healthcare and the necessary records.
p.(None): observational
...
Social / Child
Searching for indicator child:
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p.(None): Processing of the data processed up to that point requires the express data protection law
p.(None): Approval.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 51.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 53. The clinical trial of a medical device may be carried out on a pregnant or breastfeeding woman
p.(None): Mother can only be done when
p.(None): 1. the medical device to be tested in order to achieve a purpose in accordance with Section 2 (1)
p.(None): breastfeeding mothers, pregnant women or unborn children
p.(None): 2. the use of the medical device according to the knowledge of the medical sciences
p.(None): is indicated to the breastfeeding mother or pregnant woman taking the clinical trial
p.(None): is carried out, or in the case of her unborn child a purpose in accordance with Section 2 (1)
p.(None): to reach,
p.(None): 3. according to the knowledge of the medical sciences, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn or breastfed child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): or breastfeeding mothers can expect adequate test results.
p.(None): § 54. The clinical trial of a medical device may be carried out on persons who have a presence or
p.(None): Provide training or community service, not be carried out.
p.(None): Dealing with data
p.(None): Section 55. (1) During the entire course of the clinical trial, everyone involved is
p.(None): treat patient-related data with strict confidentiality. All patient-related data must be against
p.(None): unauthorized access is protected and pseudonymized as far as possible, whereby it must be ensured that
p.(None): that the additional information with which the personal data of an affected person
p.(None): can be assigned to be kept separately.
p.(None): (2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and
p.(None): set confidential handling of all data resulting from a clinical trial.
p.(None): (3) The study plan, the final report as well as all created in connection with the clinical study
p.(None): Data and documents are for specific periods after the completion or termination of the clinical trial
p.(None): to be kept by the Federal Minister of Health and Consumer Protection in a regulation pursuant to
p.(None): Section 66 are to be laid down. This regulation also specifies who is to be kept for certain
p.(None): Data or documents hits.
...
Searching for indicator children:
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p.(None): was given in writing,
p.(None): 4. The minor before the start of the clinical trial by someone dealing with minors
p.(None): Experienced clinical investigators should have an understanding appropriate to their ability to understand this
p.(None): had received,
p.(None): 5. the consent of the minor who is able to understand the essence, the meaning, the
p.(None): To see the scope and risks of the clinical trial and to determine his will accordingly,
p.(None): has been demonstrably granted, and it is ensured that the expressly by a minor
p.(None): expressed desire not to take the clinical trial or take it at any time
p.(None): to be considered by the clinical investigator
p.(None): 6. The consent can be withdrawn at any time without the minor being affected
p.(None): Disadvantage arises
p.(None): 7. with the participation in the clinical trial, no incentives or financial benefits
p.(None): Exception to an expense allowance,
p.(None): 8. the clinical trial is planned so that it takes into account the disease and the
p.(None): Developmental stage of the minor with as little pain, discomfort, fear and
p.(None): other predictable risks, including the risk threshold as well as the
p.(None): Degree of exposure specifically defined and constantly checked,
p.(None): 9. The test plan by an ethics committee that has knowledge in the field of children and
p.(None): Juvenile medicine or who deals with clinical, ethical and psychosocial issues on the
p.(None): Had been advised in the area of pediatrics and adolescent medicine, and was approved
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of
p.(None): Science stand.
p.(None): (2) Deviating from Paragraph 1 No. 2, a clinical trial on minors is also permitted if
p.(None): 1. The clinical trial is an essential extension of the scientific understanding of the
p.(None): Condition, illness or disorder of the minor and thereby either
p.(None): Can benefit patients or the patient group to which the minor belongs, and
p.(None): 2. The clinical trial for the minor with only a minimal risk and minimal burden
p.(None): brings oneself; a clinical trial has minimal risk and minimal burden if
p.(None): it is to be expected that at most it will be a minor and merely temporary
p.(None): Impairment and any symptoms or inconveniences can be very minor
p.(None): and will only appear temporarily.
p.(None): § 52. The clinical trial may be carried out on a person who is the result of a mental illness or a
p.(None): comparable impairment of their ability to make decisions has a legal representative or on
...
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 49 and
p.(None): 50 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Enlightenment including express consent under data protection law is given. Another
p.(None): Processing of the data processed up to that point requires the express data protection law
p.(None): Approval.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 51.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 53. The clinical trial of a medical device may be carried out on a pregnant or breastfeeding woman
p.(None): Mother can only be done when
p.(None): 1. the medical device to be tested in order to achieve a purpose in accordance with Section 2 (1)
p.(None): breastfeeding mothers, pregnant women or unborn children
p.(None): 2. the use of the medical device according to the knowledge of the medical sciences
p.(None): is indicated to the breastfeeding mother or pregnant woman taking the clinical trial
p.(None): is carried out, or in the case of her unborn child a purpose in accordance with Section 2 (1)
p.(None): to reach,
p.(None): 3. according to the knowledge of the medical sciences, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn or breastfed child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): or breastfeeding mothers can expect adequate test results.
p.(None): § 54. The clinical trial of a medical device may be carried out on persons who have a presence or
p.(None): Provide training or community service, not be carried out.
p.(None): Dealing with data
p.(None): Section 55. (1) During the entire course of the clinical trial, everyone involved is
p.(None): treat patient-related data with strict confidentiality. All patient-related data must be against
p.(None): unauthorized access is protected and pseudonymized as far as possible, whereby it must be ensured that
p.(None): that the additional information with which the personal data of an affected person
p.(None): can be assigned to be kept separately.
...
p.(None): Ordinance according to § 10 defined product properties, suitable names, information or
p.(None): Presentations are used that are decisive for the evaluation of the medical device.
p.(None): (3) It is also prohibited to announce or place objects on the market that are of a type or shape
p.(None): the announcement or the placing on the market are incorrect, the expectation of the user is incorrect
p.(None): awaken that these objects are themselves medical devices or have one of a medical device
p.(None): corresponding mechanism of action.
p.(None): Section 103. Information on the intended purpose in advertising materials may be used for labeling and
p.(None): Do not contradict the instructions for use and no information regarding an additional purpose
p.(None): contain.
p.(None): lay Advertising
p.(None): Section 104. Advertising intended for consumers may not be used for
p.(None): 1.medical devices that are subject to a prescription requirement according to an ordinance according to § 100,
p.(None): 2. Medical devices that are exclusively intended for healthcare professionals on or for
p.(None): to be applied to the patient, or
p.(None): 3. Medical devices, their use by consumers based on the instructions for use only in
p.(None): In connection with medical or dental treatment or surveillance
p.(None): may,
p.(None): operate.
p.(None): Section 105. Medical device advertising intended for consumers must be designed in such a way that the
p.(None): Advertising character is clearly expressed and the product is clearly represented as a medical device.
p.(None): Section 106. Medical device advertising intended for consumers may not contain any elements that
p.(None): 1. suggest that the effect corresponds to another treatment or another medical device
p.(None): or is superior
p.(None): 2. are intended exclusively or mainly for children,
p.(None): 3. Make medical treatment seem superfluous, especially by making it one
p.(None): mislead self-diagnosis, or treatment by correspondence
p.(None): recommend,
p.(None): 4. Abusive, worrying or misleading
p.(None): Get recovery certificates,
p.(None): 5. Abusive, worrying or misleading representations of the
p.(None): Changes in the human body due to illness, injury or
p.(None): Disabilities or the effect of a medical device on or in the human body
p.(None): use.
p.(None): Section 107. (1) Medical device advertising intended for consumers has at least the following information
p.(None): to contain:
p.(None): 1. the name of the medical device,
p.(None): 2. the intended use of the medical device,
p.(None): 3. the information essential for the sensible use of the medical device,
p.(None): 4. A clearly perceptible indication if the medical device is also undesirable
p.(None): May cause effects or its use requires special safety precautions.
p.(None): (2) Medical device advertising, which is intended for consumers, has a reference to this if applicable
p.(None): to include that the instructions for use be followed carefully and, if necessary, the advice of a doctor,
p.(None): Dentists, dentists, pharmacists or any other, due to their professional training
p.(None): authorized person. If advertising is carried out via acoustic or audiovisual media, this must be done
p.(None): Notice to be clearly audible acoustically.
p.(None): professional advertising
p.(None): Section 108. In the context of sales promotion for medical devices among the persons to whom under the
p.(None): Prescription, dispensing, procurement for health care facilities, construction, commissioning
p.(None): or application tasks, it is prohibited to give them a premium, fi nancial or material
p.(None): To grant, offer or promise benefits unless they are of little value and to those
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.(None): clinical trial was conducted in accordance with the study plan. An audit must go through either
p.(None): an internal sponsor unit that operates independently of the clinical unit
p.(None): Research is responsible, or be carried out by an external scientific institution.
p.(None): (14) "Inspection of a clinical trial" is one by the responsible ethics committee, the Federal Office
p.(None): for safety in healthcare, by an expert commissioned by this or by a
p.(None): foreign health authority carried out check at the test center or at the sponsor who the
p.(None): Compliance with the provisions of this federal law or other regulations on the clinical investigation of
p.(None): Medical devices checked.
p.(None): (14a) "Inspection of a performance evaluation test" is one by the Federal Office for Security in the
p.(None): Health care, an expert commissioned by this or by a foreign
p.(None): Health agency conducted review of a performance assessment review that required adherence to
p.(None): Provisions of this federal law or other provisions on the performance evaluation of in vitro
p.(None): Diagnostics checked.
p.(None): (15) “Adverse event” is any adverse clinical event in a clinical event
p.(None): Exam participants included, regardless of whether it is related to the exam
p.(None): or performance-rated medical device stands or not.
p.(None): (16) An event or a side effect within the meaning of Section 2 (17) is to be classified as serious if
p.(None): that is fatal or life threatening, causes permanent damage, or requires inpatient treatment or
p.(None): Extension of the inpatient stay is necessary. Any undesirable event or any
p.(None): Medical device side effect, the damage to a fetus, its death or a congenital
p.(None): Malformation or the appearance of a malignant tumor are in any case considered to be serious
p.(None): classified.
p.(None): Section 3
p.(None): Differentiation from other regulations
p.(None): Exceptions to the scope
p.(None): § 4. (1) This Federal Act does not apply to
p.(None): 1. Medicinal products within the meaning of the Medicinal Products Act (AMG), Federal Law Gazette № 185/1983, in accordance with Section 5
p.(None): the decision as to whether a product falls under the AMG or this federal law is made
p.(None): especially due to the main mode of action of the product,
p.(None): 2. cosmetic products within the meaning of § 5 of the Food Act 1975, Federal Law Gazette № 86, (note: from
p.(None): January 21, 2006: Food Safety and Consumer Protection Act - LMSVG, BGBl. I No. 13/2006)
p.(None): 3. human blood, blood products, blood plasma or blood cells of human origin or products,
p.(None): blood products, blood plasma or blood cells of this type at the time of placing on the market
p.(None): included, with the exception of in vitro diagnostics and medical devices within the meaning of § 2
p.(None): Paragraph 5c,
p.(None): 4. Organs, tissues or cells of human origin as well as products containing tissues or cells
p.(None): contain human origin or were obtained from such tissues or cells, be it
p.(None): because they are in-vitro diagnostics or medical devices according to § 2 Paragraph 5c,
p.(None): 5. Transplants, tissues or cells of animal origin unless a medical device is used
p.(None): Use of killed animal tissue or products made
p.(None): were obtained from animal tissue or are in-vitro diagnostics,
p.(None): 6. Natural healing deposits and products from a natural healing deposit within the meaning of Section 42a
...
Social / Incarcerated
Searching for indicator restricted:
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p.(None): sufficient practical experience in this area and
p.(None): 3. those for carrying out the tests and drafting the certificates, protocols and
p.(None): Reports, in which the tests carried out are recorded, suitability required.
p.(None): (7) The independence of the personnel commissioned with the examination must be ensured. The high of
p.(None): Payments to each examiner may not be based on the number of examinations he has carried out or the number of examinations
p.(None): Judge the results of these tests.
p.(None): (8) For cases of liability that may arise from their work, the notified body must:
p.(None): take out sufficient liability insurance, unless this liability is covered by the Republic
p.(None): Austria covered.
p.(None): (9) The notified body has
p.(None): 1. the Federal Ministry of Health on all exhibited, changed, supplemented, suspended,
p.(None): revoked or refused certificates, and
p.(None): 2. the other bodies designated under Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC
p.(None): about all suspended, revoked or refused certificates and on request via
p.(None): certificates issued
p.(None): to inform. The notified body also has all relevant additional information on request
p.(None): To make available.
p.(None): (10) If a notified body ascertains that the relevant requirements of this Federal Act of
p.(None): Manufacturers have not been met or are no longer met, or a certificate has not been issued
p.(None): should have been, it takes into account the principle of proportionality
p.(None): issued, revoked or imposed a certificate, unless the manufacturer
p.(None): ensures compliance with these requirements through appropriate remedial measures. The
p.(None): Notified body will inform the Federal Ministry of Labor, Health and Social Affairs if the
p.(None): Certificates are suspended, revoked or restricted, or the intervention of the
p.(None): Federal Minister of Labor, Health and Social Affairs could prove necessary.
p.(None): (11) The notified body has all relevant information and documents available on request
p.(None): the budgetary documentation to verify compliance with the rules for designated
p.(None): Make available.
p.(None): (12) The Federal Minister of Health can issue uniform requirements with a view to ordinance
p.(None): on the designation, monitoring and activities of relevant notified bodies.
p.(None): III. KEY PIECE
p.(None): Section 1
p.(None): Clinical evaluation and performance evaluation
p.(None): Section 38. (1) Evidence that the requirements set out in Sections 1 and 2 of Annex I to Directive 90/385 / EEC or
p.(None): Sections 1 and 3 of Annex I to Directive 93/42 / EEC are relevant to characteristics and performance
p.(None): Requirements of a medical device are met under normal operating conditions, as well as the
p.(None): Assessment of undesirable side effects and the acceptability of the benefit / risk ratio,
p.(None): to Annex I Section 5 of Directive 90/385 / EEC or Annex I Section 6 of the Directive
p.(None): 93/42 / EEC, reference must always be made on the basis of clinical data.
p.(None): (2) The evaluation of this clinical data, hereinafter referred to as "clinical evaluation", at which
p.(None): if applicable, relevant harmonized standards have to be taken into account according to a de fi ned and
p.(None): methodically flawless procedures based on a critical assessment
p.(None): 1. the available relevant scientific literature on safety, performance,
p.(None): Design features and purpose of the medical device, whereby
p.(None): a) the similarity of the medical device with the medical device to which the
p.(None): Get data, and
p.(None): b) the data is reasonably consistent with the relevant fundamental
...
Social / Laboratory Staff
Searching for indicator research staff:
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p.(None): Tasks and areas of responsibility of the people involved in the clinical trial
p.(None): Section 62. (1) The responsibilities and areas of responsibility of those involved in the clinical trial
p.(None): Persons, especially the sponsor, clinical investigator and monitor, must be specified in writing and by
p.(None): to confirm their signatures.
p.(None): (2) The clinical investigator and the monitor assume the role of sponsor
p.(None): The sponsor is permitted if this is documented and the respective responsibilities and
p.(None): Tasks are fully taken over.
p.(None): Tasks and areas of responsibility of the sponsor
p.(None): Section 63. (1) The sponsor has the clinical investigator, taking into account his professional quali fi cation,
p.(None): its availability over the entire period of the study and taking into account suitability and
p.(None): Availability of local, medical, and clinical trials available to clinical investigators
p.(None): organizational circumstances and options.
p.(None): (2) If necessary, the sponsor is responsible for appropriate monitoring of the clinical trial
p.(None): to care. For this purpose, he has one or more suitably trained and qualified people with the function
p.(None): to entrust a monitor in accordance with Section 65 or their areas of responsibility and responsibilities themselves
p.(None): perceive. Furthermore, he has to ensure that, if necessary, internal audits of the study are carried out
p.(None): can be.
p.(None): (3) The sponsor has the clinical investigator all for the safe use of the investigated
p.(None): Medical device and the proper execution of the clinical trial required documents,
p.(None): including the relevant information that will only become available during the ongoing study on
p.(None): To provide administrative support, supportive support if necessary
p.(None): Provide research staff and, if necessary, appropriate training for the clinical investigator
p.(None): and its employees in the intended and safe installation, preparation and application of the
p.(None): Medical device and its necessary accessories.
p.(None): (4) The sponsor must ensure that neither the test participant nor the
p.(None): Austrian social security institutions or third parties from providing the clinical trial
p.(None): certain medical device costs, unless
p.(None): 1. the use of which is associated with a primary individual benefit insofar as it serves to ward off one
p.(None): damage to health or to remedy physical suffering is urgently needed
p.(None): and compared to available medical devices that are already permitted on the market
p.(None): seriously increases the chances of success,
p.(None): 2. the social security institution or third parties information about the medical device used and
p.(None): the clinical trial has been made available and
p.(None): 3. Social insurance institutions or third parties based on these documents after assessing the existence
p.(None): have agreed to the requirements of sections 1 and 2 of an application for cost coverage.
p.(None): (5) The sponsor must assess the test plan and confirm it with his signature.
p.(None): (6) The sponsor may carry out its duties or obligations in whole or in part
p.(None): delegate to external scientific institutions.
p.(None): Tasks and responsibilities of the clinical investigator
p.(None): § 64. (1) Clinical investigator may only be a suitably qualified, for independent practice of
p.(None): medical or dental profession in Austria may be a qualified doctor or dentist who
p.(None): 1. is trained and experienced in the area of application of the medical device to be tested and
p.(None): 2. is familiar with the background and requirements of the clinical trial and at least one
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): Attach or provide this information and to ensure safe use
p.(None): provide exceptions for medical devices.
p.(None): (3) Each medical device must be accompanied by instructions for use in its packaging. A
p.(None): Instructions for use are for class I and class IIa medical devices within the meaning of the directive
p.(None): 93/42 / EEC or for in vitro diagnostics within the meaning of Directive 98/79 / EC in duly justified cases
p.(None): then dispensable if the proper and safe use of the medical device without
p.(None): Instructions for use is guaranteed.
p.(None): (4) The labeling of medical devices and, according to paragraph 3, their instructions for use
p.(None): must have the manufacturer's name or company name and address.
p.(None): (5) If medical devices fall within the scope of the Agreement on the European
p.(None): The economic area must be introduced in order to be placed on the market there for the first time
p.(None): Labeling, if necessary the outer packaging or the instructions for use, further
p.(None): the name or company name and the address of the person responsible for placing the product on the market for
p.(None): in vitro diagnostics from the authorized representative, provided that this is not identical to the manufacturer.
p.(None): (6) Medical devices may only be given to the user or consumer if they are for him
p.(None): or certain information is written to the patient in German. The Federal Minister for
p.(None): Health and consumer protection can be ensured by taking into account a sufficient regulation
p.(None): Information for patients and users and taking into account the guarantee of the
p.(None): Medical device safety Allow exceptions to the requirement of the German language or regulations
p.(None): about the admissibility of suitable measures other than the package leaflet for informing the
p.(None): Provide users or patients.
p.(None): § 10. The Federal Minister of Health and Women has with regard to ensuring the
p.(None): medical services of medical devices according to § 2 and with regard to the protection of health
p.(None): and safety of patients, users and, if applicable, third parties and the prevention of risks
p.(None): Ordinance to define the basic requirements for medical devices.
p.(None): Requirements for medical devices for in vitro diagnosis
p.(None): Section 11. (1) Medical devices for in-vitro diagnosis may be without prejudice to Sections 6 to 9 and one
p.(None): Ordinance pursuant to Section 10 only placed on the market, set up, put into operation and applied,
p.(None): if, in addition, the requirements according to paragraph 2 and a regulation according to paragraph 3 are met.
p.(None): (2) Medical devices for in vitro diagnosis must be designed and manufactured so that they can be used under
p.(None): Consideration of the generally recognized state of the art for the one specified by the manufacturer
p.(None): Purpose according to § 2 paragraph 5 are suitable. You need the performance parameters, especially in
p.(None): With regard to the sensitivity, specificity, precision, accuracy, reproducibility specified by the manufacturer
p.(None): and detection limits. The traceability of the calibration substances or devices
p.(None): Values attributed to or control materials must be available through available parent
p.(None): Reference measurement methods and reference materials can be guaranteed.
p.(None): (3) The Federal Minister of Health and Consumer Protection may use medical devices for in vitro
...
p.(None): Risks is required through regulation conformity assessment procedures for medical devices for the
p.(None): Prescribe vitro diagnosis as a prerequisite for placing on the market and commissioning and their
p.(None): Specify the content and implementation in more detail.
p.(None): Section 29. (1) Sets the conformity assessment procedure in accordance with an ordinance pursuant to Section 28 (1) or
p.(None): the procedure according to §§ 33 to 35 the participation of a notified body in advance, the
p.(None): Manufacturer or his authorized representative to a body of his choice designated for the fulfillment of these tasks
p.(None): turn. The simultaneous referral of several notified bodies within one
p.(None): Conformity assessment procedure for a medical device by the manufacturer or his authorized representative
p.(None): is not permitted.
p.(None): (2) In the conformity assessment procedure for a medical device, the manufacturer or the
p.(None): Notified body to take into account the results of assessments and tests that may be included in
p.(None): an intermediate stage of manufacture according to this federal law or other Austrian
p.(None): Regulations within the meaning of Section 112 (1) and (2) have been made.
p.(None): (3) The notified body is at its reasonable request all information or information
p.(None): to be submitted or made available for issuing the certificate of conformity and
p.(None): Maintenance of the conformity decision with regard to the chosen procedure are required.
p.(None): (4) The documents and correspondence regarding the procedures for conformity assessment are
p.(None): if they are carried out within the scope of this federal law, in German
p.(None): or in another official language of a contracting party to the Agreement on the European
p.(None): Economic area recognized by the notified body.
p.(None): (Note: Paragraphs 5 to 7 repealed by Federal Law Gazette I No. 119/2003)
p.(None): custom made
p.(None): § 30. (1) For each custom-made product, the manufacturer or his in the European Economic Area
p.(None): authorized representative before placing on the market for the first time in a regulation pursuant to § 28
p.(None): issue the intended declaration and make the documentation listed there available. From the
p.(None): Documentation must include the design, manufacture and performance data of the medical device
p.(None): including the intended performance, in such a way that it enables an assessment of whether
p.(None): has met the requirements of this federal law.
p.(None): (2) The manufacturer must take all necessary measures to ensure that the
p.(None): Compliance of the manufactured medical devices with the documentation according to a regulation
p.(None): § 28 is ensured. He has an assessment of the effectiveness of these measures or, if necessary, one
p.(None): Allow formal review (audit).
p.(None): (3) The Federal Office for Safety in Health Care can report all of the manufacturer
p.(None): Require custom-made products in accordance with Directive 93/42 / EEC, within the scope of this
p.(None): Federal law have been put into operation or placed on the market.
p.(None): Section 5
p.(None): Exhibit; Exemptions in the interest of health protection; Systems and
p.(None): Treatment units; Sterilization for placing on the market
p.(None): Exhibit
p.(None): Section 31. (1) Medical devices that do not comply with sections 15 and 27 may then
p.(None): Demonstration purposes, especially at trade fairs, exhibitions, demonstrations and scientific
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Social / Marital Status
Searching for indicator single:
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p.(None): Disinfection and cleaning of medical devices and their accessories as well as defense against risks and that
p.(None): Quality management when handling medical devices and their accessories.
p.(None): Section 2
p.(None): definitions
p.(None): General definitions
p.(None): § 2. (1) Medical Devices “are all instruments used individually or in combination,
p.(None): Apparatus, devices, software, materials or other objects, including those from the manufacturer
p.(None): Specifically designed for use in diagnostic or therapeutic purposes and for a flawless
p.(None): Function of the medical device software used by the manufacturer for application to people
p.(None): are intended for the following purposes:
p.(None): 1. detection, prevention, monitoring, treatment or relief of diseases,
p.(None): 2. Detect, monitor, treat, alleviate or compensate for injury or
p.(None): disabilities,
p.(None): 3. Examination, change or to replace the anatomical structure or physiological
p.(None): Operations or
p.(None): 4. Conception regulation
p.(None): and their intended main effect in or on the human body neither through
p.(None): pharmacological or immunological agents are still metabolically achieved, but their mode of action
p.(None): can be supported by such means. The new one is a reprocessed medical device
p.(None): equal.
p.(None): (1a) “Subcategory of medical devices” is a group of medical devices that are used in the same
p.(None): Areas to be used or equipped with the same technologies.
p.(None): (1b) "Generic product group" is a group of medical devices with the same or similar
p.(None): Terms of use or with technological similarities so that they are general without
p.(None): Taking into account specific characteristics that can be classified.
p.(None): (1c) "Disposable product" is a medical device that is for single use on a single person
p.(None): is determined.
p.(None): (2) "Accessories" for a medical device are objects, materials, preparations from materials and
p.(None): Software that is not itself a medical device according to paragraph 1, according to the manufacturer's express
p.(None): specified purpose but are intended
p.(None): 1. To be used together with a medical device, so that it complies with the requirements of
p.(None): Manufacturer of the medical device specified purpose of the medical device applied
p.(None): can be, or
p.(None): 2. to support the intended purpose for the medical device.
p.(None): Accessories are considered medical devices. Accessories for active implantable medical devices are themselves considered active
p.(None): implantable medical device. Accessories for an in-vitro diagnostic device are themselves considered in-vitro diagnostic devices,
p.(None): unless the products are invasive and are intended for taking samples,
p.(None): that come into direct contact with the human body for the purpose of sampling. This
p.(None): are considered medical devices within the meaning of Directive 93/42 / EEC.
p.(None): (3) "Active medical device" is any medical device that is operated by an electrical device
p.(None): Energy source or another energy source is dependent on that directly by the human
p.(None): Body or gravity generated energy. A medical device that is used to transfer energy,
p.(None): Bumps or parameters between an active medical device and the patient is used without
p.(None): the fact that there is a significant change in energy, impact or parameters does not count as active
p.(None): Medical product.
p.(None): (4) "Active implantable medical device" is any medical device that operates on an electrical device
p.(None): Energy source or any energy source other than that directly through the human body or the
...
p.(None): Standard medical devices that have to be adapted to the speci fi c
p.(None): To meet the requirements of the doctor or any other licensed user authorized to do so,
p.(None): are not considered to be custom-made.
p.(None): (7) "Manufacturer" is any natural or legal person responsible for the design, manufacture, packaging
p.(None): and labeling a medical device with a view to placing it on the market for the first time
p.(None): Name is responsible. This applies regardless of whether these activities are carried out by this person or
p.(None): Company or acting on behalf of a third party.
p.(None): (8) A manufacturer is also any natural or legal person who has one or more prefabricated ones
p.(None): Assembled, packaged, treated, prepared or labeled products or for determining the products
p.(None): Intended use as a medical device with regard to the placing on the market in your own name
p.(None): is. However, a manufacturer is not someone who has already been placed on the market without being a manufacturer within the meaning of paragraph 7
p.(None): Assembled products for a named patient according to their intended use
p.(None): adapts.
p.(None): (8a) "Authorized Representative" is the natural or established in the European Economic Area (EEA)
p.(None): legal person who has been expressly designated by the manufacturer with regard to his from this
p.(None): Federal law obligations to act on his behalf and those of the authorities and
p.(None): To be contacted in this sense in the EEA. Has a manufacturer in its own name
p.(None): Medical device, does not have a seat in a contracting party to the EEA, it must be in writing for
p.(None): at least all medical devices of the same model have a single authorized representative in
p.(None): Name EEA.
p.(None): (9) "Intended use" is the use for which the medical device is designed according to the information provided by the
p.(None): Manufacturer in the label, the instructions for use or the advertising material.
p.(None): (10) "Placing on the market" is the return of a medical device, whether for a fee or free of charge, or that
p.(None): Have it ready for delivery. A placing on the market does not exist if
p.(None): 1. it is a medical device exclusively intended for clinical testing within the meaning of § 3
p.(None): Paragraph 3 or an in vitro diagnostic medical device for performance evaluation purposes within the meaning of Section 3 Paragraph 3a
p.(None): These,
p.(None): 2. it is ensured by means of suitable measures that the medical device does not reach the consumer,
p.(None): Can reach users or operators, or
p.(None): 3. individual medical devices to a single specific person exclusively free of charge and in
p.(None): private area or neighborhood help.
p.(None): (11) "Placing on the market for the first time" is the first placing on the market of a medical device or the first
p.(None): Placing a medical device on the market after its reprocessing with a view to its distribution or
p.(None): its use within the scope of the Agreement on the European Economic Area.
p.(None): (12) "Responsible for the first placing on the market in the European Economic Area"
p.(None): 1. the manufacturer,
p.(None): 2. his representative or
p.(None): 3. the importer,
p.(None): which is a medical device for the first time within the scope of the Agreement on the European
p.(None): Puts the economic area on the market and within the scope of the Agreement on the European
p.(None): Economic area is established.
p.(None): (13) “Commissioning” is the phase in which a medical device is used by the end user as an article
p.(None): Is made available for the first time as a ready-to-use medical device according to its
p.(None): Purpose in the scope of the European Economic Area can be used. at
p.(None): active implantable medical devices is considered to be the commissioning provided by the
p.(None): medical personnel for implantation.
p.(None): (14) "Exhibiting" is the setting up or demonstration of medical devices for the purpose of advertising or
p.(None): the information of the specialist circles.
p.(None): (15) "Harmonized standards" are national standards of the contracting states to the Agreement on the
p.(None): European Economic Area implementing relevant harmonized European standards, their
p.(None): Locations as "harmonized standards" for medical devices in the Official Journal of the European Communities
p.(None): have been published. The harmonized standards are relevant monographs of the European
...
p.(None): Manufacturer of the medical device and carried out under their own responsibility.
p.(None): (6) "Monitor" is a person designated by the sponsor who is responsible for monitoring and
p.(None): reporting on the progress of the clinical trial is responsible.
p.(None): (7) “Clinical trial plan” or “Protocol” is a document that provides detailed information on the reasons,
p.(None): Intentions, goals, execution as well as planned analyzes, methodology and implementation of the clinical
p.(None): Exam contains.
p.(None): (7a) "Evaluation Plan" is a document that provides detailed information about a planned
p.(None): Performance evaluation test, especially with regard to the scientific, technical and
p.(None): medical justification, the objectives, the methodology, the intended analyzes and sampling, the
p.(None): testing performance criteria and requirements as well as the type and scope of the intended evaluation
p.(None): contains.
p.(None): (8) "Examiner" is either a patient or a healthy subject participating in a clinical
p.(None): Test or takes part in a performance evaluation test of an in vitro diagnostic medical device.
p.(None): (9) “Ethics Committee” is an independent body composed according to Section 58 (4)
p.(None): medical experts and other members whose job it is to assess whether a
p.(None): there is a scientifically adequately substantiated clinical trial and whether the safety of that
p.(None): Wellbeing, the rights and integrity of test takers are protected.
p.(None): (10) "Clinical Trial Final Report" or "Final Report" is a complete description and
p.(None): Evaluation of the clinical trial after its completion.
p.(None): (11) “Multicentre trial” is a clinical trial that corresponds to a single clinical trial
p.(None): Test plan, but is carried out at several examination sites.
p.(None): (12) "Case report scheme" or "test sheet" is a set of documents designed in such a way that all
p.(None): relevant patient and medical device related data required by the clinical trial plan
p.(None): are fully documented.
p.(None): (13) “Audit” is the comparison of the raw data and the corresponding records with the intermediate
p.(None): or final report to determine whether the raw data have been correctly reported and evaluated and the
p.(None): clinical trial was conducted in accordance with the study plan. An audit must go through either
p.(None): an internal sponsor unit that operates independently of the clinical unit
p.(None): Research is responsible, or be carried out by an external scientific institution.
p.(None): (14) "Inspection of a clinical trial" is one by the responsible ethics committee, the Federal Office
p.(None): for safety in healthcare, by an expert commissioned by this or by a
p.(None): foreign health authority carried out check at the test center or at the sponsor who the
p.(None): Compliance with the provisions of this federal law or other regulations on the clinical investigation of
p.(None): Medical devices checked.
p.(None): (14a) "Inspection of a performance evaluation test" is one by the Federal Office for Security in the
p.(None): Health care, an expert commissioned by this or by a foreign
p.(None): Health agency conducted review of a performance assessment review that required adherence to
p.(None): Provisions of this federal law or other provisions on the performance evaluation of in vitro
p.(None): Diagnostics checked.
p.(None): (15) “Adverse event” is any adverse clinical event in a clinical event
...
p.(None): because they are in-vitro diagnostics or medical devices according to § 2 Paragraph 5c,
p.(None): 5. Transplants, tissues or cells of animal origin unless a medical device is used
p.(None): Use of killed animal tissue or products made
p.(None): were obtained from animal tissue or are in-vitro diagnostics,
p.(None): 6. Natural healing deposits and products from a natural healing deposit within the meaning of Section 42a
p.(None): Paragraph 2 of the Federal Act on Hospitals and Health Centers, Federal Law Gazette No. 1/1957.
p.(None): (2) This Federal Act does not affect the 1994 Industrial Code, Federal Law Gazette No. 194.
p.(None): § 4a. (1) Medical devices according to Directive 93/42 / EEC, which are also used by the manufacturer
p.(None): determined according to the regulations for personal protective equipment of the directive 89/686 / EEC
p.(None): are also subject to the provisions of this federal law.
p.(None): (2) Medical devices according to directives 90/385 / EEC and 93/42 / EEC, which are also machines in the sense
p.(None): of Article 2 letter a of Directive 2006/42 / EC are subject to the provisions of this
p.(None): Federal law.
p.(None): Differentiation from drug regulations
p.(None): Section 5
p.(None): are to apply a drug within the meaning of the drug law, are subject to this federal law
p.(None): without prejudice to the provisions of the Medicinal Products Act relating to medicinal products.
p.(None): (2) Is a combination of medical device and medicinal product placed on the market in such a way that
p.(None): Medical device and drug form a single, interconnected product, the
p.(None): main intended effect is based on the abusive composition of the drug and that
p.(None): is intended for use in this connection only and is not reusable
p.(None): this product the drug law. The Federal Office for Safety in Health Care has at
p.(None): Assessment of the medical device part the basic requirements according to the II
p.(None): Federal law to apply, insofar as safety and performance-related medical device functions
p.(None): are affected.
p.(None): (3) Contains a medical device - with the exception of in vitro diagnostic medical devices - as an integrated component
p.(None): Sto ff, which - used separately - as a medicinal product within the meaning of the Medicinal Products Act and in addition to
p.(None): the medical device can have an effect on the human body, it is a
p.(None): Medical device in the sense of this federal law.
p.(None): (4) If a medical device contains a derivative of human blood as part of Section 2
p.(None): Paragraph 5c, this medical device is also subject to this federal law.
p.(None): Approval procedure
p.(None): § 5a. (1) The Federal Office for Safety in Health Care has at the request of a manufacturer or
p.(None): its authorized representative in the event that a product is intended to be placed on the market for the first time
p.(None): to determine whether this product fulfills one of the definitions according to § 2 Paragraphs 1 to 6 and, if necessary, via
p.(None): to decide on the classification and classi fi cation of the medical device. The manufacturer or
p.(None): whose authorized representative is domiciled in Germany. As part of this procedure, there may be an opinion
p.(None): Obtain the delimitation and classification advisory board in accordance with § 5b.
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Social / Mothers
Searching for indicator mothers:
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p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 49 and
p.(None): 50 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Enlightenment including express consent under data protection law is given. Another
p.(None): Processing of the data processed up to that point requires the express data protection law
p.(None): Approval.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 51.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 53. The clinical trial of a medical device may be carried out on a pregnant or breastfeeding woman
p.(None): Mother can only be done when
p.(None): 1. the medical device to be tested in order to achieve a purpose in accordance with Section 2 (1)
p.(None): breastfeeding mothers, pregnant women or unborn children
p.(None): 2. the use of the medical device according to the knowledge of the medical sciences
p.(None): is indicated to the breastfeeding mother or pregnant woman taking the clinical trial
p.(None): is carried out, or in the case of her unborn child a purpose in accordance with Section 2 (1)
p.(None): to reach,
p.(None): 3. according to the knowledge of the medical sciences, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn or breastfed child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): or breastfeeding mothers can expect adequate test results.
p.(None): § 54. The clinical trial of a medical device may be carried out on persons who have a presence or
p.(None): Provide training or community service, not be carried out.
p.(None): Dealing with data
p.(None): Section 55. (1) During the entire course of the clinical trial, everyone involved is
p.(None): treat patient-related data with strict confidentiality. All patient-related data must be against
p.(None): unauthorized access is protected and pseudonymized as far as possible, whereby it must be ensured that
p.(None): that the additional information with which the personal data of an affected person
p.(None): can be assigned to be kept separately.
p.(None): (2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and
p.(None): set confidential handling of all data resulting from a clinical trial.
p.(None): (3) The study plan, the final report as well as all created in connection with the clinical study
p.(None): Data and documents are for specific periods after the completion or termination of the clinical trial
p.(None): to be kept by the Federal Minister of Health and Consumer Protection in a regulation pursuant to
p.(None): Section 66 are to be laid down. This regulation also specifies who is to be kept for certain
p.(None): Data or documents hits.
p.(None): (3a) For the period of the retention periods, the right under Art. 17 data protection
p.(None): Basic regulation excluded.
p.(None): (4) All data and documents relevant to the clinical trial must be submitted to the
p.(None): Federal Office for Safety in Health Care to check compliance with the provisions of this
p.(None): Federal Act on Clinical Trials will be made available.
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Social / Occupation
Searching for indicator job:
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p.(None): is responsible in particular for the well-being of the candidate.
p.(None): (5) "Sponsor" is any natural or legal person who is responsible for planning the
p.(None): Initiation, implementation and funding of a clinical trial takes over. The sponsor must be in
p.(None): a contracting party to the EEA. The clinical investigator has the duties and the
p.(None): Sponsor to assume additional responsibility if he / she is conducting a clinical trial independently of
p.(None): Manufacturer of the medical device and carried out under their own responsibility.
p.(None): (6) "Monitor" is a person designated by the sponsor who is responsible for monitoring and
p.(None): reporting on the progress of the clinical trial is responsible.
p.(None): (7) “Clinical trial plan” or “Protocol” is a document that provides detailed information on the reasons,
p.(None): Intentions, goals, execution as well as planned analyzes, methodology and implementation of the clinical
p.(None): Exam contains.
p.(None): (7a) "Evaluation Plan" is a document that provides detailed information about a planned
p.(None): Performance evaluation test, especially with regard to the scientific, technical and
p.(None): medical justification, the objectives, the methodology, the intended analyzes and sampling, the
p.(None): testing performance criteria and requirements as well as the type and scope of the intended evaluation
p.(None): contains.
p.(None): (8) "Examiner" is either a patient or a healthy subject participating in a clinical
p.(None): Test or takes part in a performance evaluation test of an in vitro diagnostic medical device.
p.(None): (9) “Ethics Committee” is an independent body composed according to Section 58 (4)
p.(None): medical experts and other members whose job it is to assess whether a
p.(None): there is a scientifically adequately substantiated clinical trial and whether the safety of that
p.(None): Wellbeing, the rights and integrity of test takers are protected.
p.(None): (10) "Clinical Trial Final Report" or "Final Report" is a complete description and
p.(None): Evaluation of the clinical trial after its completion.
p.(None): (11) “Multicentre trial” is a clinical trial that corresponds to a single clinical trial
p.(None): Test plan, but is carried out at several examination sites.
p.(None): (12) "Case report scheme" or "test sheet" is a set of documents designed in such a way that all
p.(None): relevant patient and medical device related data required by the clinical trial plan
p.(None): are fully documented.
p.(None): (13) “Audit” is the comparison of the raw data and the corresponding records with the intermediate
p.(None): or final report to determine whether the raw data have been correctly reported and evaluated and the
p.(None): clinical trial was conducted in accordance with the study plan. An audit must go through either
p.(None): an internal sponsor unit that operates independently of the clinical unit
p.(None): Research is responsible, or be carried out by an external scientific institution.
p.(None): (14) "Inspection of a clinical trial" is one by the responsible ethics committee, the Federal Office
p.(None): for safety in healthcare, by an expert commissioned by this or by a
p.(None): foreign health authority carried out check at the test center or at the sponsor who the
p.(None): Compliance with the provisions of this federal law or other regulations on the clinical investigation of
p.(None): Medical devices checked.
...
p.(None): Order reliability as a safety officer for medical devices.
p.(None): (2) The safety officer for medical devices has made known reports about risks
p.(None): Collect and evaluate medical devices and coordinate the necessary measures in accordance with Section 72.
p.(None): He is responsible for the fulfillment of the reporting obligations insofar as they concern medical device risks, and for cooperation
p.(None): responsible under the European Medical Device Monitoring System.
p.(None): (3) The Federal Minister of Health and Consumer Protection, insofar as this is possible with regard to the
p.(None): Ensuring medical device safety and warding off risks appears necessary through
p.(None): Ordinance specifies the requirements for safety officers for medical devices
p.(None): establish.
p.(None): Medical device consultant
p.(None): Section 79. (1) Anyone who places medical devices on the market for commercial or professional purposes may only use such persons
p.(None): commissioned to visit specialist groups within the scope of the professional exercise to inform them about the respective
p.(None): To provide medical devices with technical information and to handle the medical devices properly
p.(None): to instruct those who have the necessary medical and medical technology expertise
p.(None): (Medical device consultant).
p.(None): (2) The manufacturer or a person or body commissioned by him has the medical device consultants
p.(None): to train regularly. The manufacturer has submitted to the Federal Office for Safety in Health Care
p.(None): Request to prove the expertise of his medical device consultants.
p.(None): (3) A job as a medical device consultant may only be carried out by those who are listed in paragraph 1 and in a
p.(None): Ordinance pursuant to Paragraph 5 fulfilled.
p.(None): (4) The medical device consultant has messages from members of the specialist circles about side effects,
p.(None): mutual influences, malfunctions, technical defects, contraindications, falsifications or
p.(None): other risks for medical devices must be recorded in writing and sent to the person who
p.(None): has commissioned, or to transmit its safety officer for medical devices in writing.
p.(None): (5) The Federal Minister of Health and Consumer Protection, insofar as this is possible with regard to the
p.(None): correct information for users or their instruction in proper handling is required
p.(None): appears, taking into account the requirements of certain medical device areas or certain
p.(None): Levels of trade by regulation more detailed requirements for the expertise of medical device consultants
p.(None): establish.
p.(None): V. MAIN PIECE
p.(None): Section 1
p.(None): Regulations for the erection, operation, use and maintenance of medical devices in and
p.(None): outside healthcare facilities
p.(None): General requirements
p.(None): Section 80. (1) Healthcare facilities must ensure that
p.(None): 1. Medical devices only according to their intended purpose, according to the regulations of this
p.(None): Federal law or the regulations issued on the basis thereof, the generally recognized
p.(None): Established, operated rules of technology as well as occupational safety and accident prevention regulations,
p.(None): applied and maintained,
p.(None): 2. Medical devices for common use with other medical devices, with accessories, with
p.(None): Software or with other objects only if this connection in the
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Social / Police Officer
Searching for indicator officer:
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p.(None): to another ethics committee responsible for this clinical trial as sufficient. In this
p.(None): Case, the assessing ethics committee must also announce all of the auditors involved and all of them
p.(None): Documents are made available that provide an assessment with regard to their professional quali fi cation
p.(None): and experience, as well as the existing facilities and staff.
p.(None): Section 58. (1) The governor has with regard to clinical trials outside of hospitals
p.(None): Ensure that independent ethics committees are responsible in the area of his state
p.(None): A sufficient number of tasks are performed in accordance with Section 60.
p.(None): (2) For clinical trials at hospitals, the responsible ethics committee in accordance with § 8c
p.(None): Hospital Act, Federal Law Gazette No. 1/1957.
p.(None): (3) The appointment of ethics committees in accordance with paragraph 1 is the Federal Ministry of Health and
p.(None): Women and the Federal Office for Safety in Health Care display.
p.(None): (4) The ethics committee must at least consist of:
p.(None): 1. a doctor who is authorized to practice his profession independently in Germany,
p.(None): 2. a specialist in whose specialty is the clinical examination of the medical device,
p.(None): 3. a representative of the nursing service,
p.(None): 4. a lawyer,
p.(None): 5. a pharmacist,
p.(None): 6. a technical safety officer of a hospital,
p.(None): 7. a patient representative,
p.(None): 8. a representative of a representative organization for the disabled and
p.(None): 9. Another person who does not fall under Z 1 to 8 and who is concerned with pastoral care
p.(None): Is entrusted with matters or otherwise has the required ethical competence. additional
p.(None): Experts are to be involved as far as the assessment of a clinical trial requires. The
p.(None): Ethics Committee has to be made up of women and men. Doing so if possible
p.(None): to pay attention to a balanced relationship. A representative must be appointed for each member. The in Z 1
p.(None): and 2 listed members of the ethics committee are not allowed to have clinical examiners in the frame
p.(None): the clinical trial to be assessed.
p.(None): Section 59. (1) The members of the Ethics Committee and their deputies must perform this function
p.(None): be free of instructions. You have any relationships with manufacturers or distributors of medical devices
p.(None): completely open to the governor. They have become active in the
p.(None): Ethics Committee - without prejudice to any other reasons for bias - in all matters
p.(None): contain, in which such a relationship is likely to question its full impartiality.
p.(None): (1a) Internal quality assurance measures shall be provided within the framework of the organization
p.(None): Ensure in particular the regularity of the processes and procedures.
...
p.(None): 6. quality management in the context of the clinical trial or the performance assessment test,
p.(None): 7. Art. Content, scope and implementation of the notification, declaration and documentation in accordance with § 40,
p.(None): 8. Minimum requirements for insurance in accordance with sections 47 and 48 as well
p.(None): 9. Assumption of conformity with provisions on the clinical trial of medical devices or the
p.(None): Performance assessment testing of in vitro diagnostics with regard to relevant harmonized
p.(None): standardize
p.(None): set.
p.(None): IV. MAIN PIECE
p.(None): Section 1
p.(None): Registration of manufacturers, distributors, test centers and users
p.(None): Section 67. (1) Who is responsible for the initial placing on the market of medical devices in accordance with Section 2
p.(None): Paragraph 12 is, assembles medical devices in the sense of § 33 Paragraph 1 or sterilizes them in the sense of § 34, and
p.(None): has its seat in the area of application of this federal law, taking this into consideration
p.(None): Provisions of an ordinance according to paragraph 7 to the Federal Ministry of Labor, Health and Social Affairs
p.(None): or report to a notified body before starting work. This also applies to the rest
p.(None): Placing medical devices on the market, as far as for them in a regulation according to § 99 distribution channels
p.(None): are prescribed and enrollment in the register of distributors is planned.
p.(None): (2) The notification according to paragraph 1 must at least contain:
p.(None): 1. Name or company name and address of the notifier,
p.(None): 2. the type of activity,
p.(None): 3. the type of medical devices,
p.(None): 4. Further information required for the rapid coordination of measures in accordance with sections 75 and 77
p.(None): are, in particular with regard to the security officer in accordance with § 78 and
p.(None): 5. the business license in accordance with the trade regulations, Federal Law Gazette No. 194/1994.
p.(None): The notification regarding the first placing on the market is, provided the regulation according to paragraph 7 so provides,
p.(None): to add more information about the medical devices that are placed on the market for the first time.
p.(None): (3) Bodies, facilities or persons carrying out testing, monitoring or certi fi cation activities
p.(None): carry out professionally or commercially according to this federal law, have this before the admission of
p.(None): Activity at the Federal Ministry of Labor, Health and Social Affairs or a body designated by it
p.(None): stating the name and address of the body, facility or person and the nature of the
p.(None): carried out testing, monitoring and certi fi cation activities. Notified bodies in the sense
p.(None): of Section 2 Paragraph 16 have the Federal Ministry of Labor, Health and Social Affairs or one of these
p.(None): Notified body particulars related to certificates issued in accordance with the procedures of the Annexes
p.(None): 2 to 5 of Directive 90/385 / EEC, Annexes II to VII of Directive 93/42 / EEC and Annexes III to VII
p.(None): Directive 98/79 / EC was issued, modified, supplemented, suspended, withdrawn or refused,
p.(None): tell. The Federal Minister of Labor, Health and Social Affairs has the type, form and content of the
p.(None): appropriate notifications in line with requirements related to European
p.(None): To regulate databases for medical devices in a regulation in accordance with Paragraph 7.
p.(None): (4) Healthcare facilities that operate or use medical devices or for
p.(None): Have operation or ready for use, which are specified in a regulation in accordance with paragraph 7
...
p.(None): Commission of the European Union and the other contracting parties to the Agreement on the
p.(None): Inform European Economic Area.
p.(None): (2a) Medical devices can also be covered by measures in accordance with Paragraph 1, their release
p.(None): has been suspended by the customs authorities in accordance with Article 27 (3) of Regulation (EC) № 765/2008. The
p.(None): In this case, the products concerned are in temporary storage in accordance with Article 50 of the Regulation
p.(None): (EEC) № 2913/92 of the Council of 12 October 1992 establishing the Community Customs Code, OJ.
p.(None): No.L 302 of October 19, 1992 (Customs Code).
p.(None): (3) Without prejudice to paragraph 1, the Federal Minister of Health has more detailed provisions on
p.(None): Preventing harmful effects of types or groups of medical devices or for protection
p.(None): the patient, user or third party by ordinance if this is for reasons of
p.(None): Health protection, medical device safety or in the interest of public health
p.(None): is necessary, and through this the Commission and the other parties to the European Union
p.(None): To inform the economic area accordingly. The Federal Minister of Health also went through
p.(None): Accompanying regulations required, in particular to determine
p.(None): Enforcement powers, with regard to relevant regulations of the European Union.
p.(None): Section 6
p.(None): Safety officer for medical devices; Medical device consultant
p.(None): Safety officer for medical devices
p.(None): § 78. (1) Who is responsible for the first placing on the market of medical devices in the
p.(None): Scope of the European Economic Area is and its seat in the scope of this
p.(None): Federal law, has a person with the expertise and knowledge necessary to carry out their duties
p.(None): Order reliability as a safety officer for medical devices.
p.(None): (2) The safety officer for medical devices has made known reports about risks
p.(None): Collect and evaluate medical devices and coordinate the necessary measures in accordance with Section 72.
p.(None): He is responsible for the fulfillment of the reporting obligations insofar as they concern medical device risks, and for cooperation
p.(None): responsible under the European Medical Device Monitoring System.
p.(None): (3) The Federal Minister of Health and Consumer Protection, insofar as this is possible with regard to the
p.(None): Ensuring medical device safety and warding off risks appears necessary through
p.(None): Ordinance specifies the requirements for safety officers for medical devices
p.(None): establish.
p.(None): Medical device consultant
p.(None): Section 79. (1) Anyone who places medical devices on the market for commercial or professional purposes may only use such persons
p.(None): commissioned to visit specialist groups within the scope of the professional exercise to inform them about the respective
p.(None): To provide medical devices with technical information and to handle the medical devices properly
p.(None): to instruct those who have the necessary medical and medical technology expertise
p.(None): (Medical device consultant).
p.(None): (2) The manufacturer or a person or body commissioned by him has the medical device consultants
p.(None): to train regularly. The manufacturer has submitted to the Federal Office for Safety in Health Care
p.(None): Request to prove the expertise of his medical device consultants.
p.(None): (3) A job as a medical device consultant may only be carried out by those who are listed in paragraph 1 and in a
p.(None): Ordinance pursuant to Paragraph 5 fulfilled.
p.(None): (4) The medical device consultant has messages from members of the specialist circles about side effects,
p.(None): mutual influences, malfunctions, technical defects, contraindications, falsifications or
p.(None): other risks for medical devices must be recorded in writing and sent to the person who
p.(None): has commissioned, or to transmit its safety officer for medical devices in writing.
p.(None): (5) The Federal Minister of Health and Consumer Protection, insofar as this is possible with regard to the
p.(None): correct information for users or their instruction in proper handling is required
p.(None): appears, taking into account the requirements of certain medical device areas or certain
p.(None): Levels of trade by regulation more detailed requirements for the expertise of medical device consultants
p.(None): establish.
p.(None): V. MAIN PIECE
p.(None): Section 1
p.(None): Regulations for the erection, operation, use and maintenance of medical devices in and
p.(None): outside healthcare facilities
p.(None): General requirements
p.(None): Section 80. (1) Healthcare facilities must ensure that
p.(None): 1. Medical devices only according to their intended purpose, according to the regulations of this
p.(None): Federal law or the regulations issued on the basis thereof, the generally recognized
p.(None): Established, operated rules of technology as well as occupational safety and accident prevention regulations,
p.(None): applied and maintained,
p.(None): 2. Medical devices for common use with other medical devices, with accessories, with
p.(None): Software or with other objects only if this connection in the
p.(None): Is harmless with regard to medical safety and functionality,
p.(None): 3. Medical devices are only used by people who, due to their training, their
p.(None): other knowledge or based on their practical experience and, if necessary, one
p.(None): product- or product group-specific instruction the guarantee for a proper
p.(None): Provide handling; the instructions for use and the other enclosed
p.(None): to observe safety-related information of the products involved,
p.(None): 4. before each use of a medical device, the users check the functionality,
...
p.(None): 11. Medical devices within the meaning of Section 33 (1) or Section 34 contrary to Section 35 (1) with an additional one
p.(None): CE marking or the declarations according to §§ 33 and 34 not according to § 35 paragraph 2
p.(None): holds,
p.(None): 12. leads a notified body without fulfilling the minimum criteria of section 37,
p.(None): 13. in the clinical evaluation or performance evaluation or in the clinical examination of a
p.(None): Medical device contravenes sections 38 to 65 or a regulation in accordance with section 66,
p.(None): 13a. in the performance evaluation test of an in vitro diagnostic medical device according to § 65a or a regulation
p.(None): violates § 66,
p.(None): 14. does not meet the reporting requirements of Section 67,
p.(None): 15. measures to monitor his obligation to tolerate or to support it
p.(None): Measures in accordance with section 22 subsection 2 or section 68 subsection 8 or section 69 subsection 3 do not comply,
p.(None): 16. does not comply with the reporting obligation pursuant to Section 70 or the obligation pursuant to Section 72,
p.(None): 17. the provisions and measures in the sense of a regulation according to § 73 not or not accordingly
p.(None): § 73 or an ordinance pursuant to § 73,
p.(None): 18. does not provide data in the sense of a regulation pursuant to Section 74,
p.(None): 19. does not comply with an order pursuant to sections 75 and 77,
p.(None): 19a. contravenes an ordinance pursuant to Section 77 (3),
p.(None): 19b. Commission Regulation (EU) № 722/2012 of 8 August 2012 on special
p.(None): Requirements concern those laid down in Council Directive 90/385 / EEC or 93/42 / EEC
p.(None): Requirements for active manufactured using tissue of animal origin
p.(None): contravenes implantable medical devices and medical devices,
p.(None): 20. Contrary to Section 78, does not appoint a security officer or a security officer who
p.(None): does not comply with Section 78 or a regulation pursuant to Section 78 (3),
p.(None): 21. as a security officer does not meet his obligations under Section 78,
p.(None): 22. Persons instructed to perform activities in accordance with Section 79 (1) without the requirement
p.(None): fulfill,
p.(None): 23. the activity of a medical device consultant contrary to Section 79 or a regulation pursuant to Section 79 (5)
p.(None): exerts
p.(None): 24. does not comply with the general requirements of section 80 or a regulation pursuant to section 80 (2),
p.(None): 25. the requirements of section 81 or a regulation pursuant to section 81 (1) for commissioning are not met
p.(None): Fulfills,
p.(None): 26. Does not instruct or have personnel instructed in accordance with Section 83 and does not instruct them in accordance with
p.(None): Section 83 (3) documents,
p.(None): 27. Contrary to Section 84, does not keep an inventory or does not keep the inventory accordingly
p.(None): § 84 leads,
p.(None): 28. does not meet its maintenance obligations in accordance with Section 85,
p.(None): 29. does not carry out the tests in accordance with sections 86 to 88 or a regulation in accordance with section 92 or for this
p.(None): Draws in people who do not comply with Section 90 (1),
p.(None): 30. does not meet his documentation obligation in accordance with Section 89,
p.(None): 31. does not take the measures required under § 91,
p.(None): 32. does not meet the requirements of a regulation pursuant to Section 92,
p.(None): 33. cleans, disinfects or disinfects a medical device contrary to § 93 or a regulation according to § 94
p.(None): sterilized,
p.(None): 34. the precautions and measures for quality management in accordance with an ordinance pursuant to Section 95
p.(None): Paragraph 1 does not apply
p.(None): 35. uses a medical device contrary to an ordinance according to § 96,
p.(None): 36. as the operator of a health care facility, the minimum equipment according to a
p.(None): Regulation according to § 97 is not available,
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p.(None): Gravity-generated energy, and is designed to be wholly or partially by one
p.(None): surgical or other medical intervention in the human body or through a
p.(None): medical intervention to be introduced into a natural opening of the body and is intended after the
p.(None): Intervention to stay there.
p.(None): (5) "Medical device for in-vitro diagnosis" or "in-vitro diagnostic device" is any medical device that
p.(None): 1. individually or in combination as specified by the manufacturer
p.(None): a) reagent,
p.(None): b) reagent product,
p.(None): c) calibration material,
p.(None): d) control material,
p.(None): e) kit,
p.(None): f) instrument,
p.(None): g) apparatus, device or
p.(None): h) system
p.(None): for the in vitro analysis of samples from the human body, including
p.(None): Blood and tissue donation is used, and
p.(None): 2. serves solely or predominantly to
p.(None): a) Information about physiological or pathological conditions or congenital anomalies
p.(None): give or
p.(None): (b) check the safety and tolerability of the potential recipients, or
p.(None): c) monitor a therapeutic measure.
p.(None): Sample containers, evacuated or non-evacuated, by the manufacturer are also considered to be in vitro diagnostics
p.(None): especially for the in vitro analysis of samples from the human body as
p.(None): Primary container are intended for storage. Products for general laboratory needs do not apply
p.(None): as in vitro diagnostics, unless they are based on their characteristics according to the manufacturer
p.(None): to use the intended purpose for in vitro investigations within the meaning of Z 2.
p.(None): (5a) "In-vitro diagnostic for self-use" is any in-vitro diagnostic that is based on the
p.(None): Manufacturer specified purpose of laypersons can be applied in the home environment.
p.(None): (5b) “Calibration and control material” are substances, materials and objects that are manufactured by your
p.(None): Manufacturer to compare measurement data or to test the performance characteristics of an in vitro
p.(None): Diagnostic agents are intended for the application for which it is intended.
p.(None): (5c) "Medical device with a derivative from human blood" is a medical device according to the
p.(None): Directive 90/385 / EEC or Directive 93/42 / EEC, which contains a substance as a component, which - separately
p.(None): used - as a drug component or drug from human blood or blood plasma in the sense
p.(None): of Art. 1 Point 10 of Directive 2001/83 / EC and in addition to the medical device
p.(None): can have an effect on the human body. The aforementioned shock is referred to below as “derivative
p.(None): from human blood ”.
p.(None): (6) "Custom-made products" are all medical devices, with the exception of in vitro diagnostic medical devices, which according to
p.(None): written prescription from a doctor or another legally based on their professional qualifications
p.(None): authorized person, under their responsibility, specially made according to speci fi c design criteria
p.(None): and are intended for exclusive use in a named patient.
p.(None): Standard medical devices that have to be adapted to the speci fi c
p.(None): To meet the requirements of the doctor or any other licensed user authorized to do so,
p.(None): are not considered to be custom-made.
p.(None): (7) "Manufacturer" is any natural or legal person responsible for the design, manufacture, packaging
p.(None): and labeling a medical device with a view to placing it on the market for the first time
...
p.(None): Section 84. (1) Health care facilities have medical devices that are listed in a regulation
p.(None): are designated in accordance with section 92 to keep an inventory.
p.(None): (2) The inventory in the sense of paragraph 1 is to be drawn up in such a way that it is determined immediately
p.(None): can, if and where, medical devices, which are affected by measures according to § 77, in this
p.(None): Healthcare facility operated.
p.(None): Maintenance of medical devices
p.(None): § 85. (1) Medical devices are subject to the manufacturer's instructions through inspection, maintenance
p.(None): and maintenance to be comprehensible and properly maintained in such a way that the
p.(None): Functionality and safety for patients, users and third parties is guaranteed.
p.(None): (2) Inspection, maintenance and repair as well as all associated tests may only
p.(None): People or positions are transferred due to their professional training and through
p.(None): practical experience gained and their knowledge, especially with regard to
p.(None): Relevant legislation and standards are able to take the necessary measures
p.(None): to set and assess as well as to recognize the possible effects and dangers and their activity
p.(None): to be carried out professionally. You have to carry out and evaluate the exams in their
p.(None): professional assessment be free of instructions.
p.(None): (3) Health care facilities have all the necessary precautions for the
p.(None): to ensure proper maintenance of medical devices.
p.(None): (4) Provided the corresponding types, groups or classes of medical devices in a regulation
p.(None): are listed in accordance with Section 92
p.(None): 1. the institution of social insurance and medical and / or accident care for medical devices, the
p.(None): the insured / cared for by the above-mentioned carriers for treatment in a home
p.(None): Environment or for your own use or as part of the
p.(None): Insurance / pension benefits are at least partially reimbursed in costs, and
p.(None): 2. Institutions that have life-saving or other important medical devices in their health
p.(None): or have it ready for use in a public area,
p.(None): to take the necessary precautions for their proper maintenance. The Federal Minister
p.(None): for health and women in determining these medical devices in a regulation pursuant to Section 92
p.(None): significant risks to patient health and safety and deterioration
p.(None): the performance of these medical devices that can be expected in the absence of proper maintenance
p.(None): would be to take care. In the regulation according to § 92 can also special requirements
p.(None): with regard to the correct preparation and use of these medical devices and with regard to
p.(None): required training measures.
p.(None): § 86. After the repair of medical devices, they must be safe and functional
p.(None): essential structural and functional characteristics are checked, insofar as they are due to the repair
p.(None): can be influenced.
p.(None): Recurring safety-related tests of medical devices
p.(None): Section 87. Health care facilities must ensure that medical devices that are used in a medical device
p.(None): Ordinance according to § 92 are regularly listed by a person or position that is suitable for this purpose
p.(None): be checked.
p.(None): Section 88. (1) The examinations in accordance with Section 87 must take into account the type of examination
p.(None): Medical device and the information provided by the manufacturer to a sufficient extent to the
p.(None): to be able to assess the safety and functional condition of the medical device. Accessories or
p.(None): Product combinations that can affect the medical device to a significant degree are too
...
Social / Soldier
Searching for indicator armed forces:
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p.(None): Health led by rules of procedure.
p.(None): (9) The activity in the delimitation and classification advisory board is voluntary, without prejudice to paragraph 10.
p.(None): Any travel expenses are the members of the delimitation and classification advisory board, their deputies
p.(None): and consulted experts according to the highest fee level of the travel fee regulation 1955, BGBl.
p.(None): No. 133 to replace on request.
p.(None): (10) The members of the delimitation and classification advisory board, which are appointed by the Federal Office for
p.(None): Health care was entrusted with the preparation of relevant expert reports
p.(None): adequate compensation in terms of effort and time, which the
p.(None): Applicant has to bear.
p.(None): II. MAIN PIECE
p.(None): Section 1
p.(None): Medical device requirements
p.(None): Requirements for placing on the market and commissioning
p.(None): § 6. It is forbidden to place medical devices on the market, to set them up, to install them, to put them into operation
p.(None): take or apply if
p.(None): 1. there is reasonable suspicion that they meet the basic requirements within the meaning of sections 8 and 9
p.(None): and a regulation according to § 10 or, if applicable, does not meet the requirements of § 11 or
p.(None): 2. their expiry date has passed.
p.(None): Section 7. (1) Medical devices may only be placed on the market and in facilities in accordance with Section 112
p.(None): of the healthcare system can be put into operation if the for the first placing on the market
p.(None): Responsible for its seat in a party to the Agreement on the European Economic Area
p.(None): Has.
p.(None): (2) The provisions of section 6 (2) and (1) do not apply to the armed forces when deployed in accordance with section 2
p.(None): Paragraph 1 lit. a of the Wehrgesetzes 2001, BGBl. I № 146, as well as in the immediate preparation of this
p.(None): Insert.
p.(None): basic requirements
p.(None): § 8. (1) Medical devices must be designed and manufactured in such a way that their use does not comply with the
p.(None): clinical condition or patient safety still endangers the safety of users or third parties,
p.(None): if they are used under the intended conditions and for the intended purposes.
p.(None): Any risks and side effects that may result from proper installation, implantation or
p.(None): Application may need to be considered taking into account the effectiveness of the medical devices
p.(None): be defensible to the state of the medical sciences and technology and the protection of health
p.(None): and security must be guaranteed.
p.(None): (2) Medical devices must be designed, manufactured and packaged in such a way that they are suitable for use by
p.(None): Manufacturer to provide specified medical services in accordance with § 2 paragraph 1 or 5 if they
p.(None): Are exposed to loads under normal conditions of use and under those of the manufacturer
p.(None): provided transportation and storage conditions may occur.
p.(None): (3) The design and construction of medical devices must take into account the
p.(None): generally recognized state of science and technology according to the principles of integrated
p.(None): Straighten security. When choosing the most appropriate solutions for design and construction are in the
p.(None): apply the following principles in the order specified:
p.(None): 1. Elimination or minimization of risks by integrating the security concept into the
p.(None): Development and construction of the medical device,
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Searching for indicator army:
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p.(None): Economic area of the European Commission and the other contracting parties for the
p.(None): Execution of tasks in the context of conformity assessment procedures for medical devices
p.(None): notified body.
p.(None): (17) “Side effects” are those when the medical device is used as intended
p.(None): occurring and related undesirable side effects.
p.(None): (18) "Mutual influence" means those that occur when used as intended
p.(None): Effects of
p.(None): 1. Medical devices on top of each other or
p.(None): 2. Medical devices and other objects, substances or preparations made of substances on top of each other.
p.(None): (19) "Maintenance" of a medical device is the entirety of the measures for preservation and
p.(None): Restoration of the desired target state and for the determination and assessment of the
p.(None): Current state of a medical device. The term "maintenance" includes inspection, maintenance and
p.(None): Repair.
p.(None): (20) "Inspection" of a medical device is the entirety of all measures to determine and
p.(None): Assessment of the current status.
p.(None): (21) "Maintenance" of a medical device is the entirety of all measures for the preservation of the
p.(None): desired target state, the flawless safety and functionality of the medical device
p.(None): guaranteed.
p.(None): (22) "Repair" of a medical device are the measures to restore the
p.(None): specified target state, the flawless safety and functionality of the medical device
p.(None): guaranteed.
p.(None): (23) 'Healthcare institution' means any institution, post or institution in which
p.(None): Medical devices used by healthcare professionals or authorized professionals
p.(None): operated or applied, including those of the Federal Army that the
p.(None): Serve medical supplies.
p.(None): Definitions for clinical evaluation and testing of medical devices as well as for
p.(None): Performance assessment testing of in vitro diagnostic medical devices
p.(None): § 3. (1) "Clinical evaluation" is the medical evaluation of a medical device in the sense of
p.(None): Annex 7 № 1.1 of Council Directive 90/385 / EEC of June 20, 1990 on the approximation of the
p.(None): Member States legislation on active implantable medical devices, OJ. EG № L 189
p.(None): of July 20, 1990, and Annex X № 1.1 of Council Directive 93/42 / EEC of June 14, 1993 on
p.(None): Medical devices, OJ EG No.L 169 of July 12, 1993.
p.(None): (2) "Clinical Trial" is a systematic examination of a medical device, with the exception of in-
p.(None): in vitro diagnostics, on test subjects, with the aim of
p.(None): 1. to determine the performance data of the medical device or to check whether the performance of the
p.(None): Medical device under normal conditions of use by the manufacturer or other sponsor
p.(None): correspond to the specified performance data,
p.(None): 2. any side effects that occur under normal conditions of use according to type, severity and
p.(None): Frequency in order to determine whether this taking into account the given
p.(None): Services represent acceptable risks or
p.(None): 3. Determine mechanisms of action and suitable clinical areas of application of the medical device,
p.(None): to investigate the safety and effectiveness of the medical device.
p.(None): (2a) "Performance evaluation test" is a systematic examination of an in vitro diagnostic medical device in
p.(None): medical laboratories or other suitable facilities on samples from test participants,
p.(None): including blood and tissue donations, with the aim of
p.(None): 1. to determine the performance data of the in vitro diagnostic medical device or to check whether the performance of the
...
p.(None): indicates that these medical devices are only placed on the market and put into operation for the first time
p.(None): if their compliance with this federal law is established. At demonstrations they are
p.(None): take necessary precautions to protect people.
p.(None): (2) When issuing in vitro diagnostics, it must also be ensured that these products
p.(None): not on samples originating from participants or otherwise taken during the exhibition
p.(None): be used.
p.(None): Exemptions in the interest of health protection
p.(None): Section 32. (1) Notwithstanding Sections 15 and 27, the Federal Office for Safety in Health Care
p.(None): on request the placing on the market and the commissioning of individual medical devices for which the
p.(None): Conformity assessment procedures according to a regulation according to § 28 were not carried out, only in
p.(None): Allow Austria if their use is necessary in the interest of health protection.
p.(None): (2) The Federal Minister of Health and Consumer Protection has through the regulation in accordance with § 28
p.(None): considering an adequate supply of safe and efficient medical devices
p.(None): and the availability of equivalent medical devices, for which the procedures according to §§ 15 and 27
p.(None): have already been carried out to determine the more specific conditions under which the
p.(None): Exemption according to paragraph 1 can be granted, including the type and content of the applications and the
p.(None): the documents to be attached in accordance with paragraph 1.
p.(None): (3) When deploying the Federal Army in accordance with Section 2 (1) lit. a of the Wehrgesetzes 2001 and at
p.(None): Immediate preparation of this deployment is for placing on the market and commissioning individual
p.(None): in this case of medical devices required an exemption according to paragraph 1 is not required.
p.(None): (4) An exemption within the meaning of paragraph 1 is not required if a in Austria for
p.(None): Self-employed professional authorized doctor confirms that a medical device is for a specific
p.(None): Patients to avert a life threatening or a serious health impairment
p.(None): is necessary and the success of treatment with a medical device, in which the procedure according to §§ 15
p.(None): and 27 have already been carried out, are unlikely to be achieved.
p.(None): Systems and treatment centers; Sterilization for placing on the market
p.(None): Section 33. (1) Any natural or legal person, each with a CE marking
p.(None): Medical devices of the directive 93/42 / EEC according to their purpose and within the
p.(None): Application restrictions provided by the manufacturer are put together in the form of a system or
p.(None): Placing a treatment unit on the market for the first time must provide an explanation of the content
p.(None): have ready that
p.(None): 1. the mutual compatibility of medical devices according to the instructions of the manufacturers
p.(None): checked and carried out the work steps according to the instructions,
p.(None): 2. it packs the system or the treatment center and pertinent user instructions,
p.(None): including the relevant instructions from the manufacturer, and
p.(None): 3. the entire activity has been suitably monitored and controlled internally.
p.(None): (2) Are systems or treatment units with medical devices of Directive 93/42 / EEC, the
...
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p.(None): Declarations of conformity to be issued and the conditions for affixing the CE
p.(None): Labelling,
p.(None): 2. the assignment of the conformity assessment procedures to the individual classes of medical devices,
p.(None): 3. Which conformity assessment procedures by a notified body and which by the manufacturer
p.(None): are to be carried out
p.(None): 4. those conformity assessment procedures which may be initiated by the authorized representative
p.(None): can be
p.(None): 5. the storage and availability of documents related to
p.(None): Conformity assessment procedures,
p.(None): 6. the more detailed conditions under which an exemption according to § 32 is granted
p.(None): can, as well as Art. Content, implementation and handling of the relevant applications,
p.(None): 7. Art. Content and requirements of the declarations to be issued for custom-made products and Art
p.(None): and content of the documentation to be made available for the responsible authorities,
p.(None): 8. Art. Content, availability and transmission of records of custom-made products that are in
p.(None): Placed on the market or put into operation,
p.(None): 9. Which conformity assessment procedures may have to be carried out if medical devices
p.(None): are manufactured or put into operation in healthcare facilities.
p.(None): (3) The Federal Minister of Health and Consumer Protection may, in an ordinance pursuant to para. 1,
p.(None): as far as it is in the interest of a uniform and proper implementation of the conformity assessment
p.(None): and the procedure for placing systems, treatment centers and the on the market
p.(None): Sterilizing CE-marked medical devices according to the relevant guidelines of the
p.(None): The European Union also serves to stipulate:
p.(None): 1. the procedure for different interpretations of the provisions of this federal law
p.(None): concerns the conformity assessment of medical devices within the scope of
p.(None): Conformity assessment procedures,
p.(None): 2. More detailed regulations on the recognition of intermediate examinations within the framework of
p.(None): Conformity assessment procedures,
p.(None): 3. the procedure for the conformity assessment of medical devices according to § 5 paragraphs 3 and 4,
p.(None): 4. the procedure for submitting applications to extend decisions of
p.(None): notified bodies within the framework of conformity assessment procedures and
p.(None): 5. the procedure for systems and treatment units as well as for the sterilization of
p.(None): Medical devices according to §§ 33 to 35 including the explanations required for this.
p.(None): (4) The Federal Minister of Health and Consumer Protection can, provided this is with regard to the
p.(None): Protection of the health and safety of patients, users and third parties or the defense of significant
p.(None): Risks is required through regulation conformity assessment procedures for medical devices for the
p.(None): Prescribe vitro diagnosis as a prerequisite for placing on the market and commissioning and their
p.(None): Specify the content and implementation in more detail.
p.(None): Section 29. (1) Sets the conformity assessment procedure in accordance with an ordinance pursuant to Section 28 (1) or
p.(None): the procedure according to §§ 33 to 35 the participation of a notified body in advance, the
p.(None): Manufacturer or his authorized representative to a body of his choice designated for the fulfillment of these tasks
p.(None): turn. The simultaneous referral of several notified bodies within one
...
p.(None): a medical device or its labeling or instructions for use.
p.(None): Section 77. (1) The Federal Office for Safety in Health Care determines that medical devices
p.(None): 1. Can endanger the health or safety of patients, users or third parties, too
p.(None): if they are properly installed, commissioned, maintained and their intended purpose
p.(None): be used accordingly, or
p.(None): 2. the basic requirements within the meaning of §§ 8, 9, a regulation according to § 10 or
p.(None): if applicable, do not meet the requirements of Section 11, or
p.(None): 2a. the fulfillment of the requirements according to Z 2 is insufficiently demonstrated, or
p.(None): 3. otherwise or with regard to their manufacture, show defects that endanger patients,
p.(None): Can lead users or third parties
p.(None): it has to take all appropriate measures to withdraw these products from the market
p.(None): to ensure that they are placed on the market for the first time as well as further, their commissioning and their operation,
p.(None): Prohibit, restrict, or comply with certain requirements
p.(None): addictive or to users, patients and third parties on dangers or appropriate
p.(None): To take precautions. As far as it is to prevent imminent dangers for
p.(None): the Federal Office for Safety in Health Care can do this
p.(None): Take measures without previous procedure or before issuing a decision. About here
p.(None): however, a written notification must be issued within four weeks.
p.(None): (2) Relate to measures in accordance with paragraph 1 of medical devices with a CE marking in accordance with this
p.(None): Federal law, the Federal Minister of Health and Consumer Protection has the
p.(None): Commission of the European Union and the other contracting parties to the Agreement on the
p.(None): Inform European Economic Area.
p.(None): (2a) Medical devices can also be covered by measures in accordance with Paragraph 1, their release
p.(None): has been suspended by the customs authorities in accordance with Article 27 (3) of Regulation (EC) № 765/2008. The
p.(None): In this case, the products concerned are in temporary storage in accordance with Article 50 of the Regulation
p.(None): (EEC) № 2913/92 of the Council of 12 October 1992 establishing the Community Customs Code, OJ.
p.(None): No.L 302 of October 19, 1992 (Customs Code).
p.(None): (3) Without prejudice to paragraph 1, the Federal Minister of Health has more detailed provisions on
p.(None): Preventing harmful effects of types or groups of medical devices or for protection
p.(None): the patient, user or third party by ordinance if this is for reasons of
p.(None): Health protection, medical device safety or in the interest of public health
p.(None): is necessary, and through this the Commission and the other parties to the European Union
p.(None): To inform the economic area accordingly. The Federal Minister of Health also went through
p.(None): Accompanying regulations required, in particular to determine
p.(None): Enforcement powers, with regard to relevant regulations of the European Union.
p.(None): Section 6
p.(None): Safety officer for medical devices; Medical device consultant
p.(None): Safety officer for medical devices
p.(None): § 78. (1) Who is responsible for the first placing on the market of medical devices in the
p.(None): Scope of the European Economic Area is and its seat in the scope of this
p.(None): Federal law, has a person with the expertise and knowledge necessary to carry out their duties
p.(None): Order reliability as a safety officer for medical devices.
p.(None): (2) The safety officer for medical devices has made known reports about risks
p.(None): Collect and evaluate medical devices and coordinate the necessary measures in accordance with Section 72.
p.(None): He is responsible for the fulfillment of the reporting obligations insofar as they concern medical device risks, and for cooperation
p.(None): responsible under the European Medical Device Monitoring System.
p.(None): (3) The Federal Minister of Health and Consumer Protection, insofar as this is possible with regard to the
p.(None): Ensuring medical device safety and warding off risks appears necessary through
p.(None): Ordinance specifies the requirements for safety officers for medical devices
p.(None): establish.
p.(None): Medical device consultant
p.(None): Section 79. (1) Anyone who places medical devices on the market for commercial or professional purposes may only use such persons
p.(None): commissioned to visit specialist groups within the scope of the professional exercise to inform them about the respective
p.(None): To provide medical devices with technical information and to handle the medical devices properly
...
p.(None): correspond,
p.(None): 38. runs a business without the required approval in accordance with an ordinance pursuant to Section 98 (3),
p.(None): 39. dispenses a medical device contrary to a regulation in accordance with sections 99 or 100,
p.(None): 40. People for the purpose of collecting orders for medical devices within the meaning of Section 101
p.(None): visits or places the order,
p.(None): 41. Markings or presentations used, information or announcements that make sense
p.(None): of Section 102 are misleading or suitable to raise false expectations,
p.(None): 42. advertises medical devices contrary to sections 104 to 107, section 108 or section 109,
p.(None): 43. grants, offers or promises a premium, financial or material advantages contrary to Section 108,
p.(None): 44. in breach of Section 108, requests a premium, fi nancial or material benefits, promises himself or
p.(None): assumes
p.(None): 45. contrary to § 112 places medical devices on the market, puts them into operation or in institutions of the
p.(None): Operates or applies health care,
p.(None): is guilty of an administrative offense if the act is not threatened with judicial punishment and
p.(None): is to be punished with a fine of up to € 25,000, in the event of repetition up to € 50,000.
p.(None): Section 111a. The applies to all personal names used in this federal law
p.(None): chosen form for both genders.
p.(None): Section 3
p.(None): costs
p.(None): Section 111b. (1) The Federal Minister of Health and Women, in agreement with the
p.(None): Federal Minister of Finance Fees for those to be carried out under this Federal Act
p.(None): Official acts and activities of federal agencies, the necessity of which derives from this
p.(None): Federal law and the regulations or relevant legal acts of the
p.(None): European Union results, set in one tariff. Fees for reports can also be included in the tariff
p.(None): Section 67 and for reports in connection with implant registers in accordance with an ordinance pursuant to Section 73
p.(None): be determined.
p.(None): (2) When determining the chargeable facts, on the one hand, experience has shown that in the
p.(None): Average costs incurred, on the other hand on the importance or the benefit for the
p.(None): To take due account of fee debtors. The tariff and its changes are in the “Official Journal
p.(None): to the Wiener Zeitung ”.
p.(None): (3) Is the result of this federal law, the regulations issued on the basis thereof
p.(None): or legal acts of the European Union the need for official acts or activities of
p.(None): Federal agencies for which a tariff has not been set are the actual costs incurred
p.(None): prescribe.
p.(None): (4) For cash expenses, the party, regardless of the fees set in the tariff in accordance with § 76 of the
p.(None): General Administrative Procedure Act 1991, Federal Law Gazette No. 51.
p.(None): Section 4
p.(None): Final and transitional provisions
p.(None): § 112. (1) Medical devices within the meaning of Directive 93/42 / EEC, which are physically available as individual
p.(None): Products conforming to the regulations in force on December 31, 1994 before June 15
p.(None): Were placed on the market in Austria in 1998, and
p.(None): 1. which are safe and efficient,
p.(None): 2. whose expiry date has not passed and
p.(None): 3. which do not have to be installed or assembled by the end user,
p.(None): may still be put into operation during a transition period until June 30, 2001, unless
p.(None): the requirements according to § 8 are not fulfilled or measures according to § 77 are taken.
p.(None): (2) Medical devices for in vitro diagnosis, which are valid in Austria on December 7, 1998
p.(None): existing regulations, may continue until December 6, 2003 in Austria
p.(None): To be placed on the market. In vitro diagnostic medical devices placed on the market in this way may be used until the end of the
p.(None): Placed on the market or put into service in Austria on 6 December 2005, unless
p.(None): the requirements according to §§ 8, 9 and 11 are not met or measures according to § 77 are taken.
p.(None): There are changes to these regulations for the purpose of protecting human beings from one
p.(None): apply direct or indirect health hazards.
...
Social / Women
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p.(None): Instructions for use are for class I and class IIa medical devices within the meaning of the directive
p.(None): 93/42 / EEC or for in vitro diagnostics within the meaning of Directive 98/79 / EC in duly justified cases
p.(None): then dispensable if the proper and safe use of the medical device without
p.(None): Instructions for use is guaranteed.
p.(None): (4) The labeling of medical devices and, according to paragraph 3, their instructions for use
p.(None): must have the manufacturer's name or company name and address.
p.(None): (5) If medical devices fall within the scope of the Agreement on the European
p.(None): The economic area must be introduced in order to be placed on the market there for the first time
p.(None): Labeling, if necessary the outer packaging or the instructions for use, further
p.(None): the name or company name and the address of the person responsible for placing the product on the market for
p.(None): in vitro diagnostics from the authorized representative, provided that this is not identical to the manufacturer.
p.(None): (6) Medical devices may only be given to the user or consumer if they are for him
p.(None): or certain information is written to the patient in German. The Federal Minister for
p.(None): Health and consumer protection can be ensured by taking into account a sufficient regulation
p.(None): Information for patients and users and taking into account the guarantee of the
p.(None): Medical device safety Allow exceptions to the requirement of the German language or regulations
p.(None): about the admissibility of suitable measures other than the package leaflet for informing the
p.(None): Provide users or patients.
p.(None): § 10. The Federal Minister of Health and Women has with regard to ensuring the
p.(None): medical services of medical devices according to § 2 and with regard to the protection of health
p.(None): and safety of patients, users and, if applicable, third parties and the prevention of risks
p.(None): Ordinance to define the basic requirements for medical devices.
p.(None): Requirements for medical devices for in vitro diagnosis
p.(None): Section 11. (1) Medical devices for in-vitro diagnosis may be without prejudice to Sections 6 to 9 and one
p.(None): Ordinance pursuant to Section 10 only placed on the market, set up, put into operation and applied,
p.(None): if, in addition, the requirements according to paragraph 2 and a regulation according to paragraph 3 are met.
p.(None): (2) Medical devices for in vitro diagnosis must be designed and manufactured so that they can be used under
p.(None): Consideration of the generally recognized state of the art for the one specified by the manufacturer
p.(None): Purpose according to § 2 paragraph 5 are suitable. You need the performance parameters, especially in
p.(None): With regard to the sensitivity, specificity, precision, accuracy, reproducibility specified by the manufacturer
p.(None): and detection limits. The traceability of the calibration substances or devices
p.(None): Values attributed to or control materials must be available through available parent
p.(None): Reference measurement methods and reference materials can be guaranteed.
p.(None): (3) The Federal Minister of Health and Consumer Protection may use medical devices for in vitro
p.(None): Diagnosis, insofar as this is in view of ensuring the medical performance of such
p.(None): Medical devices according to § 2 paragraph 5 and with regard to the protection of health and safety of
...
p.(None): Dignity comes from the production, application and use of in vitro diagnostic medical devices
p.(None): and to protect human integrity and privacy. With regard to corresponding
p.(None): Diagnostic measures is the confidentiality of personal data Art. 4 Z 1 of the Regulation (EU)
p.(None): 2016/679 for the protection of natural persons when processing personal data, for free
p.(None): Traffic and repealing Directive 95/46 / EC (General Data Protection Regulation), OJ No. L 119 dated
p.(None): May 4, 2016 p. 1 through appropriate precautions and discrimination on the ground
p.(None): genetic systems not allowed.
p.(None): statutory authorizations
p.(None): § 12. Regulations in accordance with § 10 and § 11 paragraph 3 are, as far as it concerns the electrical safety and the
p.(None): of the measurement and calibration law, Federal Law Gazette № 152/1950, covers measuring functions of medical devices, in
p.(None): To be agreed with the Federal Minister for Economic Affairs.
p.(None): Section 2
p.(None): Harmonized standards
p.(None): § 13. (1) To the extent that harmonized standards within the meaning of this Federal Act are observed, this is
p.(None): assume that the respective provisions of this federal law will be complied with, unless it
p.(None): the cases of section 14 or section 77 apply.
p.(None): (1a) The manufacturers must comply with the Common Technical Speci fi cations. Come in
p.(None): duly substantiated cases do not follow these speci fi cations, they must choose solutions that meet the requirements
p.(None): Level of specifications are at least equivalent.
p.(None): (2) The Federal Minister of Health and Women has the sites of the relevant national
p.(None): harmonized standards, the relevant monographs of the European Pharmacopoeia and the
p.(None): Announce relevant Common Technical Specifications in the Federal Law Gazette.
p.(None): § 14. The Federal Minister of Labor, Health and Social Affairs has, if the reasonable suspicion
p.(None): exists that the harmonized standards and the relevant relevant to them in accordance with § 2 Paragraph 15
p.(None): Monographs of the European Pharmacopoeia and Common Technical Speci fi cations, the
p.(None): do not meet the basic requirements in the sense of sections 8 and 9 and a regulation in accordance with section 10,
p.(None): in addition to any necessary measures in accordance with sections 68, 75 or 77, those in accordance with the guidelines
p.(None): 90/385 / EEC, 93/42 / EEC and 98/79 / EC procedures therefor provided for at Community level
p.(None): initiate.
p.(None): Section 3
p.(None): CE marking
p.(None): § 15. (1) Medical devices with the exception of custom-made products, medical devices according to § 32, for
p.(None): clinical testing of certain medical devices as well as in vitro diagnostics for
p.(None): Performance evaluation purposes may only be placed on the market and put into operation if
p.(None): they with the CE marking in accordance with this federal law or on the basis of the guidelines
p.(None): 90/385 / EEC, 93/42 / EEC and 98/79 / EC issued national regulations of other contracting parties of the
p.(None): Agreement on the European Economic Area.
p.(None): (2) Medical devices may only be provided with the CE marking if they can be proven
p.(None): 1. meet the basic requirements within the meaning of sections 8 and 9 and a regulation under section 10,
p.(None): 2. meet any other regulations applicable to medical devices in accordance with § 16 which refer to them
p.(None): Taking into account their intended purpose, and
...
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 49 and
p.(None): 50 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Enlightenment including express consent under data protection law is given. Another
p.(None): Processing of the data processed up to that point requires the express data protection law
p.(None): Approval.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 51.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 53. The clinical trial of a medical device may be carried out on a pregnant or breastfeeding woman
p.(None): Mother can only be done when
p.(None): 1. the medical device to be tested in order to achieve a purpose in accordance with Section 2 (1)
p.(None): breastfeeding mothers, pregnant women or unborn children
p.(None): 2. the use of the medical device according to the knowledge of the medical sciences
p.(None): is indicated to the breastfeeding mother or pregnant woman taking the clinical trial
p.(None): is carried out, or in the case of her unborn child a purpose in accordance with Section 2 (1)
p.(None): to reach,
p.(None): 3. according to the knowledge of the medical sciences, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn or breastfed child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): or breastfeeding mothers can expect adequate test results.
p.(None): § 54. The clinical trial of a medical device may be carried out on persons who have a presence or
p.(None): Provide training or community service, not be carried out.
p.(None): Dealing with data
p.(None): Section 55. (1) During the entire course of the clinical trial, everyone involved is
p.(None): treat patient-related data with strict confidentiality. All patient-related data must be against
p.(None): unauthorized access is protected and pseudonymized as far as possible, whereby it must be ensured that
p.(None): that the additional information with which the personal data of an affected person
p.(None): can be assigned to be kept separately.
p.(None): (2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and
p.(None): set confidential handling of all data resulting from a clinical trial.
p.(None): (3) The study plan, the final report as well as all created in connection with the clinical study
p.(None): Data and documents are for specific periods after the completion or termination of the clinical trial
p.(None): to be kept by the Federal Minister of Health and Consumer Protection in a regulation pursuant to
p.(None): Section 66 are to be laid down. This regulation also specifies who is to be kept for certain
p.(None): Data or documents hits.
p.(None): (3a) For the period of the retention periods, the right under Art. 17 data protection
p.(None): Basic regulation excluded.
p.(None): (4) All data and documents relevant to the clinical trial must be submitted to the
...
p.(None): Examiners perform the tasks of the sponsor within the meaning of Section 3 (5).
p.(None): ethics committees
p.(None): Section 57. (1) The clinical trial of a medical device may only be carried out if the
p.(None): Assessment has been obtained from the responsible ethics committee.
p.(None): (2) In the context of a multicentre examination, a responsible ethics committee can issue the opinion
p.(None): to another ethics committee responsible for this clinical trial as sufficient. In this
p.(None): Case, the assessing ethics committee must also announce all of the auditors involved and all of them
p.(None): Documents are made available that provide an assessment with regard to their professional quali fi cation
p.(None): and experience, as well as the existing facilities and staff.
p.(None): Section 58. (1) The governor has with regard to clinical trials outside of hospitals
p.(None): Ensure that independent ethics committees are responsible in the area of his state
p.(None): A sufficient number of tasks are performed in accordance with Section 60.
p.(None): (2) For clinical trials at hospitals, the responsible ethics committee in accordance with § 8c
p.(None): Hospital Act, Federal Law Gazette No. 1/1957.
p.(None): (3) The appointment of ethics committees in accordance with paragraph 1 is the Federal Ministry of Health and
p.(None): Women and the Federal Office for Safety in Health Care display.
p.(None): (4) The ethics committee must at least consist of:
p.(None): 1. a doctor who is authorized to practice his profession independently in Germany,
p.(None): 2. a specialist in whose specialty is the clinical examination of the medical device,
p.(None): 3. a representative of the nursing service,
p.(None): 4. a lawyer,
p.(None): 5. a pharmacist,
p.(None): 6. a technical safety officer of a hospital,
p.(None): 7. a patient representative,
p.(None): 8. a representative of a representative organization for the disabled and
p.(None): 9. Another person who does not fall under Z 1 to 8 and who is concerned with pastoral care
p.(None): Is entrusted with matters or otherwise has the required ethical competence. additional
p.(None): Experts are to be involved as far as the assessment of a clinical trial requires. The
p.(None): Ethics Committee has to be made up of women and men. Doing so if possible
p.(None): to pay attention to a balanced relationship. A representative must be appointed for each member. The in Z 1
p.(None): and 2 listed members of the ethics committee are not allowed to have clinical examiners in the frame
p.(None): the clinical trial to be assessed.
p.(None): Section 59. (1) The members of the Ethics Committee and their deputies must perform this function
p.(None): be free of instructions. You have any relationships with manufacturers or distributors of medical devices
p.(None): completely open to the governor. They have become active in the
p.(None): Ethics Committee - without prejudice to any other reasons for bias - in all matters
p.(None): contain, in which such a relationship is likely to question its full impartiality.
p.(None): (1a) Internal quality assurance measures shall be provided within the framework of the organization
p.(None): Ensure in particular the regularity of the processes and procedures.
p.(None): (2) The implementation of the agendas of the ethics committee and the proper establishment
p.(None): Its decisions and statements must be set out in writing in the rules of procedure, which of the
p.(None): Approval by the responsible governor is required.
p.(None): (3) The sponsor or clinical investigator has all the necessary documents for the ethics committee
p.(None): Assessment of the clinical trial in accordance with § 43, in particular also evidence of qualifications, the trial plan,
p.(None): the evidence of the technical safety of the medical device, the preclinical documents, the
...
p.(None): Specify the form and procedure of the reports in accordance with paragraphs 1 to 5. With active implantable
p.(None): Medical devices, for medical devices of classes IIa, IIb and III of directive 93/42 / EEC and for in vitro
p.(None): Diagnostics in Appendix II and in-vitro diagnostics for self-application of Directive 98/79 / EC can be obtained from
p.(None): Federal Minister of Health communicating all information that identifies the medical device
p.(None): enable as well as the labeling and instructions for use if these medical devices
p.(None): be put into operation within the scope of this federal law. The Federal Minister for
p.(None): Health can also regulate the reporting obligations, modalities and access authorizations in this regulation
p.(None): With regard to the European database as defined by Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC
p.(None): establish.
p.(None): Section 2
p.(None): monitoring
p.(None): Section 68. (1) Companies, facilities or persons who work professionally or commercially with medical devices
p.(None): bypass, in particular manufacture, test, store, transport, pack, exhibit, in
p.(None): Bring traffic or put it together within the meaning of Section 33 (1), the medical devices professionally or
p.(None): professionally maintain, convert, assemble, adapt or process the medical devices professionally
p.(None): or professionally clean, disinfect or sterilize or medical devices in facilities of the
p.(None): With regard to these activities, the application or operation of health care is subject to
p.(None): Monitoring.
p.(None): (2) Monitoring within the meaning of paragraph 1 is carried out by the organs of the Federal Office for Security in the
p.(None): Healthcare, the Federal Minister of Health and Women or by commissioned by them
p.(None): Expert. The activity of relevant accredited bodies, from
p.(None): Federal Minister of Health and Women recognized organizer of proficiency tests, by operators of
p.(None): Medical device registries or other organizers from the Federal Minister of Health and Women
p.(None): recognized cross-regional comparative tests and assessments related to
p.(None): Medical devices.
p.(None): (3) Insofar as within the scope of conformity assessment procedures according to a regulation according to § 28
p.(None): Monitoring is provided, it is carried out by the for the respective conformity assessment procedure
p.(None): competent notified body. Monitoring by notified bodies is carried out in accordance with a regulation
p.(None): according to § 28.
p.(None): (4) The monitoring pursuant to Paragraph 1 can relate to all aspects that affect security,
p.(None): Functionality and quality of medical devices as well as the protection of health and safety
p.(None): Can influence patients, users or third parties.
p.(None): (5) The surveillance of health care facilities can take into account the
p.(None): The respective hazard potential is carried out systematically, on a sample basis or in the event of an incident, especially in the
p.(None): With regard to possible threats to the life or health of patients, users or third parties
p.(None): in connection with medical devices or with a view to ensuring a quality-assured
p.(None): Provision, application and maintenance of medical devices in the interest of health. Lies a
p.(None): Violation of provisions of this federal law or on the basis of decrees issued
p.(None): before, the institution must be instructed to remedy the defects within a reasonable period of time. comes
p.(None): when surveillance reveals that a violation of the provisions of this federal law or
p.(None): on the basis of enacted regulations the life and health of patients, users
p.(None): or third parties is endangered, the necessary measures to protect life and the
p.(None): Health of these people.
p.(None): (6) The monitoring of facilities and establishments by establishments, facilities or persons
p.(None): have been commissioned with the storage and transport of medical devices within the meaning of paragraph 1
p.(None): only permitted if circumstances exist which justify the assumption that medical devices are stored or
p.(None): the means of transport are misused as storage facilities via which to process the
p.(None): Transport agendas may be used beyond the time required.
p.(None): (7) The organs of the Federal Office for Safety in Health Care, the Federal Ministry for
p.(None): Health and women and the experts commissioned in accordance with paragraph 2 are authorized to
p.(None): 1. to enter and view real estate, business premises, business premises, means of transport, in
p.(None): or on which an activity according to paragraph 1 is carried out,
p.(None): 2. Visiting and checking medical devices, especially putting them into operation and
p.(None): Taking samples
p.(None): 3. to inspect and check any necessary measuring and testing equipment,
p.(None): 4. those based on this federal law or the ordinances issued under this federal law
p.(None): documents to be kept available
p.(None): a) Development, manufacturing, testing, clinical testing and evaluation, performance evaluation test
p.(None): and performance evaluation of in vitro diagnostics, acquisition, storage, packaging, in-circulation
p.(None): Bringing and other whereabouts of medical devices,
p.(None): b) the erection, operation, application, preparation and maintenance of medical devices,
p.(None): c) Precautions and measures for quality management when handling medical devices,
p.(None): d) measures to ensure the safety of medical devices and to avert risks,
p.(None): in particular also according to § 72,
p.(None): e) the information and advertising material on the market,
p.(None): f) the performance of testing, monitoring and certi fi cation activities in accordance with this
p.(None): Federal law,
p.(None): g) the conformity assessment,
p.(None): h) the fulfillment of the basic requirements within the meaning of sections 8 and 9 and a regulation
p.(None): according to § 10 and other relevant information for medical device safety
p.(None): to request, inspect and, in justified cases, make copies or copies thereof and
p.(None): 5. to request all necessary information, in particular about the operations mentioned in item 4.
p.(None): (8) Companies, facilities and people in accordance with paragraph 1 must tolerate measures in accordance with paragraphs 5 to 7
p.(None): and the bodies responsible for monitoring the Federal Office for Safety in Health Care, the
p.(None): Federal Ministry of Health and Women and the experts commissioned in accordance with paragraph 2
p.(None): to support the fulfillment of their tasks. You are committed to these premises
p.(None): Medical devices and records to make the prescribed or regulatory
p.(None): to allow the ordered test, to provide the necessary staff and resources and the
p.(None): To provide information and to submit the documents necessary for the fulfillment of the tasks of the monitoring
p.(None): entrusted bodies or the experts commissioned in accordance with paragraph 2 are required.
p.(None): (9) The official acts in accordance with paragraphs 5 to 8 are, except in the event of imminent danger or if the
p.(None): there is reasonable reason to believe that the effectiveness of the official act will be impaired during the
p.(None): Carry out operating times and announce them in advance. The organs and the experts according to paragraph 2
p.(None): in their surveillance activities must take care that each is not absolutely necessary
p.(None): Disruption or hindrance to the activities of companies, facilities or persons in accordance with paragraph 1
p.(None): is avoided.
p.(None): (10) The Federal Minister of Health and Women has an appropriate perspective
p.(None): and effective control for the following calendar year a directive on the implementation of the
p.(None): To issue inspections (inspection plan). The Federal Office for Safety in Health Care has under
p.(None): Compliance with this guideline and the Federal Ministry of Health and Women by
p.(None): Report on the execution on March 31 of the following calendar year.
p.(None): (11) Market surveillance authority within the meaning of Regulation (EC) № 765/2008 of the European
p.(None): Parliament and of the Council of 9 July 2008 on the rules for accreditation and
p.(None): Market surveillance in connection with the marketing of products and the lifting of
p.(None): Regulation (EEC) № 339/93 for products within the meaning of this federal law is the Federal Office for
p.(None): Healthcare security.
p.(None): (12) The Federal Office for Safety in Health Care has in accordance with the requirements of
p.(None): Federal Ministry of Health to create market surveillance programs for medical devices and
p.(None): to update and carry out regularly. These are for the Federal Minister of Health
p.(None): To submit approval. The Federal Office for Safety in Health Care has these programs
p.(None): to other Member States and the European Commission and to the public by means of
p.(None): to provide electronic means of communication and, if necessary, by other means.
p.(None): (13) The Federal Ministry of Health has the functioning of the market surveillance activity of the
p.(None): Federal Office for Safety in Health Care regularly, but at least every four years
p.(None): review and evaluate. The results of these reviews are the other Member States and the
p.(None): To be communicated to the European Commission and by means of electronic means of communication and, if necessary
p.(None): to make other means available to the public.
p.(None): Monitoring of testing, monitoring and certification bodies;
p.(None): Monitoring the notified bodies
p.(None): Section 69. (1) Surveillance in accordance with Section 68 is also subject to those bodies, institutions or persons who
...
p.(None): § 85. (1) Medical devices are subject to the manufacturer's instructions through inspection, maintenance
p.(None): and maintenance to be comprehensible and properly maintained in such a way that the
p.(None): Functionality and safety for patients, users and third parties is guaranteed.
p.(None): (2) Inspection, maintenance and repair as well as all associated tests may only
p.(None): People or positions are transferred due to their professional training and through
p.(None): practical experience gained and their knowledge, especially with regard to
p.(None): Relevant legislation and standards are able to take the necessary measures
p.(None): to set and assess as well as to recognize the possible effects and dangers and their activity
p.(None): to be carried out professionally. You have to carry out and evaluate the exams in their
p.(None): professional assessment be free of instructions.
p.(None): (3) Health care facilities have all the necessary precautions for the
p.(None): to ensure proper maintenance of medical devices.
p.(None): (4) Provided the corresponding types, groups or classes of medical devices in a regulation
p.(None): are listed in accordance with Section 92
p.(None): 1. the institution of social insurance and medical and / or accident care for medical devices, the
p.(None): the insured / cared for by the above-mentioned carriers for treatment in a home
p.(None): Environment or for your own use or as part of the
p.(None): Insurance / pension benefits are at least partially reimbursed in costs, and
p.(None): 2. Institutions that have life-saving or other important medical devices in their health
p.(None): or have it ready for use in a public area,
p.(None): to take the necessary precautions for their proper maintenance. The Federal Minister
p.(None): for health and women in determining these medical devices in a regulation pursuant to Section 92
p.(None): significant risks to patient health and safety and deterioration
p.(None): the performance of these medical devices that can be expected in the absence of proper maintenance
p.(None): would be to take care. In the regulation according to § 92 can also special requirements
p.(None): with regard to the correct preparation and use of these medical devices and with regard to
p.(None): required training measures.
p.(None): § 86. After the repair of medical devices, they must be safe and functional
p.(None): essential structural and functional characteristics are checked, insofar as they are due to the repair
p.(None): can be influenced.
p.(None): Recurring safety-related tests of medical devices
p.(None): Section 87. Health care facilities must ensure that medical devices that are used in a medical device
p.(None): Ordinance according to § 92 are regularly listed by a person or position that is suitable for this purpose
p.(None): be checked.
p.(None): Section 88. (1) The examinations in accordance with Section 87 must take into account the type of examination
p.(None): Medical device and the information provided by the manufacturer to a sufficient extent to the
p.(None): to be able to assess the safety and functional condition of the medical device. Accessories or
p.(None): Product combinations that can affect the medical device to a significant degree are too
p.(None): consider.
p.(None): (2) The Federal Minister of Health and Consumer Protection has in the regulation pursuant to § 92 in
p.(None): With regard to the safety of patients, users and third parties and the proper condition of
p.(None): Medical devices denote those types, groups or classes of medical devices that are regular
...
p.(None): Testing, monitoring and certi fi cation of quality management systems with regard to the establishment,
p.(None): Application, operation, maintenance, disinfection and sterilization of medical devices or
p.(None): certain types or groups of medical devices in healthcare facilities and for
p.(None): Ensuring the fulfillment of the requirements according to a regulation according to paragraph 2 requirements and
p.(None): Specify requirements for those bodies that check quality management systems in accordance with paragraphs 1 and 2,
p.(None): monitor or certi fi cate. He has any relevant national and international standards
p.(None): consider.
p.(None): § 96. The Federal Minister of Health and Consumer Protection has, if this with regard to
p.(None): serious public health interests or averting serious risks are required,
p.(None): by regulation the application or operation of certain types or groups of medical devices
p.(None): to restrict healthcare facilities whose quality management systems
p.(None): in this regard demonstrably meet the requirements of an ordinance pursuant to Section 95 (1) or which are stated in
p.(None): Are certified in accordance with an ordinance pursuant to Section 95 (2).
p.(None): minimum standards
p.(None): § 97. The Federal Minister of Health and Consumer Protection has, if this with regard to
p.(None): serious public health interests or averting serious risks are required,
p.(None): regarding certain medical services by regulation minimum standards for the provision
p.(None): of these services required medical devices.
p.(None): VI. KEY PIECE
p.(None): Section 1
p.(None): Special regulations for the operation
p.(None): Section 98. (1) The Federal Minister of Health and Women, in agreement with the Federal Minister
p.(None): for business and work, provided that this is in keeping with proper operation and the
p.(None): required quality, safety and performance of medical devices as well as the protection of safety and
p.(None): Health of the patient, the user or third parties is required by special regulation
p.(None): Provisions for companies or institutions that use medical devices within the scope of this
p.(None): Establish, put on the market, process or store federal law.
p.(None): (2) In a regulation in accordance with paragraph 1 with regard to the safety and performance of
p.(None): Medical devices and the protection of patients, users or third parties, in particular regulations
p.(None): about
p.(None): 1. production, storage, acquisition and distribution,
p.(None): 2. Precautions for information and advice as well as instruction in the company and in the
p.(None): Application of medical devices,
p.(None): 3. Personnel requirements,
p.(None): 4. definition of the respective areas of responsibility of the personnel,
p.(None): 5. Condition, size and equipment of the premises,
p.(None): 6. Hygiene requirements,
p.(None): 7. operational precautions and processes in the context of medical device monitoring and defense
p.(None): of risks,
p.(None): 8. Maintenance of medical devices in healthcare facilities and others
p.(None): Operators or users,
p.(None): 9. Quality management measures in manufacturing and other handling
p.(None): Medical devices,
p.(None): 10. other operational arrangements for good sales and service practice and
p.(None): 11. the keeping and storage of evidence of those relevant to medical devices
p.(None): Operations.
p.(None): (3) In a regulation pursuant to paragraph 1, provision must also be made for certain establishments to manufacture and
...
p.(None): who are assigned tasks in connection with the implementation of this federal law, for
p.(None): Confidentiality about all facts that became known to them exclusively from this activity
p.(None): Committed.
p.(None): Section 110a. (1) To ensure the safety of medical devices and to ensure protection
p.(None): of people's lives and health may be required for the implementation of this federal law
p.(None): Data (Art. 4 Z 1 General Data Protection Regulation) about the manufacture, the placing on the market, the
p.(None): Be ready, building, using, testing, clinical evaluation and testing
p.(None): Performance evaluation and performance evaluation test, preparation, commissioning, the
p.(None): Quality management, maintenance, market surveillance and vigilance of medical devices
p.(None): be processed with automation support.
p.(None): (2) To ensure the safety of medical devices and to ensure the protection of
p.(None): Life and health of people are allowed for the enforcement of this federal law with regard to
p.(None): Medical device monitoring requires personal data from patients
p.(None): as well as subjects in connection with the use of medical devices
p.(None): be processed with automation support. The processing of this data by the Federal Office for
p.(None): Healthcare security must be pseudonymized as long as the data is for purposes
p.(None): medical device monitoring in this form are required.
p.(None): (3) The Federal Office for Safety in Health Care is authorized to provide data within the meaning of paragraphs 1 and 2
p.(None): automation supported
p.(None): 1. the Federal Ministry of Health and Women and subordinate authorities for the purposes of
p.(None): Paragraph 1
p.(None): 2. the Austrian Agency for Health and Food Security, the Advisory Board in accordance with Section 117 (2)
p.(None): as well as experts, insofar as they are assigned tasks in the execution of this federal law
p.(None): which correspond to the intended use of paragraphs 1 and 2,
p.(None): 3. the Austrian Federal Institute for Health Care, university institutes and other the
p.(None): Institutions serving research, insofar as they are in the interest of public health, for tasks
p.(None): in the sense of the intended use of paragraphs 1 and 2,
p.(None): 4. the Austrian Chamber of Pharmacists, the Austrian Chamber of Physicians and the Medical Chambers in
p.(None): the federal states, the Austrian Chamber of Dentists, the umbrella organization of the upscale
p.(None): medical-technical services, the midwifery committee, the social security institutions and the
p.(None): Umbrella association of social security institutions, insofar as this data is an essential prerequisite for
p.(None): form the tasks assigned to them by law,
p.(None): 5. the health care facilities insofar as they place medical devices on the market or
p.(None): apply and the safe use or protection of life or health of
p.(None): People require it
p.(None): 6. the World Health Organization within the meaning of the purpose stated in paragraphs 1 and 2, and
p.(None): 7. the competent authorities and notified bodies of the Contracting States to the Agreement on the
p.(None): European Economic Area and the European Commission for tasks in the sense of
p.(None): Purpose of paragraphs 1 and 2
p.(None): to transmit.
p.(None): (4) The Federal Office for Safety in Health Care and the Federal Ministry of Health and
p.(None): Women or a body designated by the latter are also authorized to collect data within the meaning of Art. 14a of the
p.(None): Directive 93/42 / EEC on medical devices and Art. 12 of Directive 98/79 / EC on in vitro diagnostic medical devices
p.(None): in the European database provided there and the necessary information to the responsible
p.(None): Authorities and notified bodies of the contracting parties to the Agreement on the European
p.(None): Economic area and the European Commission to ensure uniform application of the
p.(None): Implementation of directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC.
p.(None): Section 2
p.(None): Penalties
p.(None): Section 111. Who
p.(None): 1. places a medical device on the market contrary to § 6, erects, installs, puts into operation or
p.(None): applies or places on the market or starts up in contravention of Section 7 (1),
p.(None): 2. a medical device without information corresponding to § 9 for users, consumers or
p.(None): Patient donates
p.(None): 2a. contravenes Section 11 or a regulation pursuant to Section 11 (3),
p.(None): 3. places a medical device on the market or puts it into operation which, contrary to § 15, does not comply with the CE
p.(None): Marking is provided,
p.(None): 4. provides a medical device with a CE marking contrary to Sections 15 to 21,
p.(None): 5. does not meet the conditions of section 23 (1) or does not follow measures in accordance with section 23 (2),
p.(None): 6. places a medical device on the market or puts it into operation for which a conformity assessment does not
p.(None): or was not made in accordance with Section 27 or a regulation in accordance with Section 28,
p.(None): 7. as a manufacturer of a custom-made product or as his authorized representative, according to his obligations
p.(None): § 30 does not comply,
p.(None): 8. Issues a medical device for demonstration purposes, without its obligations according to § 31
...
p.(None): 36. as the operator of a health care facility, the minimum equipment according to a
p.(None): Regulation according to § 97 is not available,
p.(None): 37. an operation contrary to the special regulations for the operation according to a regulation
p.(None): Section 98 (1) conducts or carries out activities within the meaning of Section 98 (5) without Section 98 (5)
p.(None): correspond,
p.(None): 38. runs a business without the required approval in accordance with an ordinance pursuant to Section 98 (3),
p.(None): 39. dispenses a medical device contrary to a regulation in accordance with sections 99 or 100,
p.(None): 40. People for the purpose of collecting orders for medical devices within the meaning of Section 101
p.(None): visits or places the order,
p.(None): 41. Markings or presentations used, information or announcements that make sense
p.(None): of Section 102 are misleading or suitable to raise false expectations,
p.(None): 42. advertises medical devices contrary to sections 104 to 107, section 108 or section 109,
p.(None): 43. grants, offers or promises a premium, financial or material advantages contrary to Section 108,
p.(None): 44. in breach of Section 108, requests a premium, fi nancial or material benefits, promises himself or
p.(None): assumes
p.(None): 45. contrary to § 112 places medical devices on the market, puts them into operation or in institutions of the
p.(None): Operates or applies health care,
p.(None): is guilty of an administrative offense if the act is not threatened with judicial punishment and
p.(None): is to be punished with a fine of up to € 25,000, in the event of repetition up to € 50,000.
p.(None): Section 111a. The applies to all personal names used in this federal law
p.(None): chosen form for both genders.
p.(None): Section 3
p.(None): costs
p.(None): Section 111b. (1) The Federal Minister of Health and Women, in agreement with the
p.(None): Federal Minister of Finance Fees for those to be carried out under this Federal Act
p.(None): Official acts and activities of federal agencies, the necessity of which derives from this
p.(None): Federal law and the regulations or relevant legal acts of the
p.(None): European Union results, set in one tariff. Fees for reports can also be included in the tariff
p.(None): Section 67 and for reports in connection with implant registers in accordance with an ordinance pursuant to Section 73
p.(None): be determined.
p.(None): (2) When determining the chargeable facts, on the one hand, experience has shown that in the
p.(None): Average costs incurred, on the other hand on the importance or the benefit for the
p.(None): To take due account of fee debtors. The tariff and its changes are in the “Official Journal
p.(None): to the Wiener Zeitung ”.
p.(None): (3) Is the result of this federal law, the regulations issued on the basis thereof
p.(None): or legal acts of the European Union the need for official acts or activities of
p.(None): Federal agencies for which a tariff has not been set are the actual costs incurred
p.(None): prescribe.
p.(None): (4) For cash expenses, the party, regardless of the fees set in the tariff in accordance with § 76 of the
p.(None): General Administrative Procedure Act 1991, Federal Law Gazette No. 51.
p.(None): Section 4
p.(None): Final and transitional provisions
p.(None): § 112. (1) Medical devices within the meaning of Directive 93/42 / EEC, which are physically available as individual
p.(None): Products conforming to the regulations in force on December 31, 1994 before June 15
...
p.(None): June 7, 2000 in force.
p.(None): (4) Section 2 (2), Section 2 (13), Section 4 (1) 3 to 5, Section 5 (3), Section 12, Section 14, Section 18 (1), Section 23 (2), Section 24, § 67
p.(None): Paragraphs 1 to 3, Section 76 Paragraph 2, Section 77 Paragraph 3, Section 111 Z 19a, Section 112 Paragraphs 1 and 2, Section 113, Section 116a, Section 117 Paragraph 1 Section 2
p.(None): this federal law in the version of the federal law BGBl. I № 117/1999 come into force on December 7th
p.(None): 1999 in force.
p.(None): (5) § 104 and § 111a in the version of the Federal Law BGBl. I № 33/2002 follow one month
p.(None): the first of the month following the announcement of the Federal Law BGBl. I No. 33/2002.
p.(None): (6) Section 5 (3) and Section 29 in the version of the Federal Law BGBl. I № 119/2003 come into force with
p.(None): Entry into force of an ordinance pursuant to Section 28 (1).
p.(None): (7) Section 3 (14) and (14a), Section 5 (2), Section 22 (2), Section 23 (1), Section 26, Section 30 (3), Section 35 (2) and Section 40
p.(None): Paragraphs 1 and 2, Section 41 Paragraph 5, Section 44, Section 55 Paragraph 4, Section 56 Paragraph 3, Section 58 Paragraph 3, Section 67 Paragraph 1, 3 and 4, Section 68 Paragraph 2, 7 , 8th
p.(None): and 10, section 70 subsection 1, 3 and 4, section 71, section 75, section 76 subsection 2, section 77 subsection 1, section 79 subsection 2, section 98 subsection 3 and 4 and section 110a
p.(None): Paragraphs 3 and 4 in the version of Federal Law BGBl. I No. 107/2005 come into force on January 1, 2006.
p.(None): (8) At the end of December 31, 2005, pending proceedings according to those listed in paragraph 7
p.(None): Provisions are to be continued by the Federal Office for Safety in Health Care. The
p.(None): Administrative files are immediately from the Federal Ministry of Health and Women to the Federal Office
p.(None): for security in healthcare.
p.(None): (9) The introductory words of Section 2, Paragraph 1, Section 2, Paragraphs 1a to 1c, Section 2, Paragraph 5c, Section 2, Paragraphs 7, 8 and 8a, Section 3, Paragraph 2,
p.(None): 2a, 2b, 4, 5, 8, 9 and 15, § 4 Abs. 1 Z 1, 4 and 6, § 4a, §§ 5a and 5b including headings, § 8 Abs. 4 and 5, the
p.(None): Introductory words of section 15 subsection 2, section 22 subsections 2 and 3, section 23, sections 26a and 26b including the heading, section 28 subsection 2 no.4,
p.(None): Section 29 (1), the introductory words of Section 33 (1), Section 34, Section 36 (2), Section 37 (9) and (12), the heading of
p.(None): Section 1 of III. Main piece, § 38, § 40, §§ 40a and 40b including headings, § 41 paragraph 1, 2, 4 and 6,
p.(None): Section 42 (8), Section 43, Section 44, Section 47 (1), (2) and (3), Section 49, Section 50 (1), 2 and 4, Section 51, Section 52a (3), Section 56 (3) to 7,
p.(None): Section 59 (1), 1a and 3, Section 60 (1) to (3), Section 61, Section 63 (4) to (6), Section 64 (1), 4 and 7, Section 65, Section 65a (1) and
p.(None): 2, section 66, section 67 (7), section 70 (1), (3), (4), (6) and (7), section 77 (1) lines 2a and 3, section 77 (2a), section 111 (5), 13 and 15,
p.(None): § 113, § 116 paragraphs 2 and 3, § 116a No. 7, in the version of the Federal Law BGBl. I № 143/2009 come into play
p.(None): March 21, 2010 in force. Section 68 (11) to (13) in the version of the Federal Law Gazette I No. 143/2009 also comes into effect
p.(None): Effective January 1, 2010.
p.(None): (10) Data protection consent in connection with clinical trials that were carried out before
p.(None): May 25, 2018, do not need to be renewed.
p.(None): (11) Sections 11 (4), 49 (4), 5 and 6, 50 (1), 52a (3) and 5, 55 (1), 59 (3), 64
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): Signature of the test participant. If the test participant is not in the
p.(None): Is the consent must be given before a witness who has the consent of his
p.(None): Has to confirm signature.
p.(None): (2) Unless otherwise stipulated in Section 51, consent is only legally effective if the
p.(None): Examiner is able to determine the nature, importance, scope, benefits, risks and burdens of the
p.(None): to inspect the clinical trial and then determine his will.
p.(None): (3) Consent to participate in the clinical trial may be withdrawn at any time. Are for
p.(None): participation in the clinical trial requires multiple consents, so the clinical trial may take place
p.(None): this person will not be continued if even one of these consents is withdrawn.
p.(None): (4) The test participants and, if applicable, legal representatives (§ 1034 ABGB) must write to
p.(None): the insurance cover according to § 47 will be informed.
p.(None): Protection of certain groups of people
p.(None): Section 51. (1) The clinical trial of a medical device may only be carried out on minors if
p.(None): if
p.(None): 1. The medical device that is being tested helps to achieve a purpose in accordance with Section 2 (1)
p.(None): Minors is intended and clinical trial for the validation of data used in clinical
p.(None): Examinations on adults or other research methods are essential
p.(None): is required,
p.(None): 2. the application of the medical device that is being tested according to the knowledge of the medical device
p.(None): Science is indicated to be given to the minor on whom the clinical trial is being conducted
p.(None): will achieve a purpose according to § 2 paragraph 1 and the inclusion in the
p.(None): clinical trial related benefits for the trial subject outweigh the risk
p.(None): 3. the consent of the legal guardian can be proven after appropriate clarification and
p.(None): was given in writing,
p.(None): 4. The minor before the start of the clinical trial by someone dealing with minors
p.(None): Experienced clinical investigators should have an understanding appropriate to their ability to understand this
p.(None): had received,
p.(None): 5. the consent of the minor who is able to understand the essence, the meaning, the
p.(None): To see the scope and risks of the clinical trial and to determine his will accordingly,
p.(None): has been demonstrably granted, and it is ensured that the expressly by a minor
p.(None): expressed desire not to take the clinical trial or take it at any time
p.(None): to be considered by the clinical investigator
p.(None): 6. The consent can be withdrawn at any time without the minor being affected
p.(None): Disadvantage arises
p.(None): 7. with the participation in the clinical trial, no incentives or financial benefits
p.(None): Exception to an expense allowance,
p.(None): 8. the clinical trial is planned so that it takes into account the disease and the
p.(None): Developmental stage of the minor with as little pain, discomfort, fear and
p.(None): other predictable risks, including the risk threshold as well as the
p.(None): Degree of exposure specifically defined and constantly checked,
p.(None): 9. The test plan by an ethics committee that has knowledge in the field of children and
p.(None): Juvenile medicine or who deals with clinical, ethical and psychosocial issues on the
p.(None): Had been advised in the area of pediatrics and adolescent medicine, and was approved
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of
p.(None): Science stand.
p.(None): (2) Deviating from Paragraph 1 No. 2, a clinical trial on minors is also permitted if
p.(None): 1. The clinical trial is an essential extension of the scientific understanding of the
p.(None): Condition, illness or disorder of the minor and thereby either
p.(None): Can benefit patients or the patient group to which the minor belongs, and
p.(None): 2. The clinical trial for the minor with only a minimal risk and minimal burden
p.(None): brings oneself; a clinical trial has minimal risk and minimal burden if
p.(None): it is to be expected that at most it will be a minor and merely temporary
p.(None): Impairment and any symptoms or inconveniences can be very minor
p.(None): and will only appear temporarily.
p.(None): § 52. The clinical trial may be carried out on a person who is the result of a mental illness or a
p.(None): comparable impairment of their ability to make decisions has a legal representative or on
p.(None): judicial or official order stopped or according to the Housing Act, BGBl.
p.(None): No. 155/1990, is not carried out.
p.(None): Section 52a. (1) A clinical trial, by its nature, can only be used in emergency situations in which appropriate
p.(None): Time no consent of the legal representative can be obtained, can be carried out at
p.(None): a person who is unable to consent to have a clinical trial performed if:
p.(None): 1. There are no indications that either the patient refused the clinical trial
p.(None): or would reject or the requirements of Section 52 exist,
p.(None): 2. Such research for the validation of data used in clinical trials for consent
p.(None): have been obtained by persons capable of providing information or using other research methods, and
p.(None): absolutely necessary for the clinical evaluation of the safety and effectiveness of the medical device
p.(None): are and can only be carried out in emergency situations,
p.(None): 3. the medical device that is being tested to fulfill a purpose as defined in Section 2 (1)
p.(None): Z 1 to 3 is determined in an emergency situation,
p.(None): 4. the use of the medical device that is being tested according to the knowledge of the medical
...
Searching for indicator youth:
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p.(None): 4. for the purpose of statistics as a basis for planning, quality assurance and quality reporting
p.(None): in Austrian healthcare and
p.(None): 5. for scientific purposes
p.(None): Implant register for active implantable medical devices, soft tissue implants, cardiovascular,
p.(None): to carry neurological and orthopedic implants.
p.(None): (2) The following data categories can be processed in the registers:
p.(None): 1. patient identification (year of birth, gender, area-specific personal identifier),
p.(None): 2. Data about the implanting healthcare facility, in particular for its identification,
p.(None): 3. relevant clinical data on medical history, current state of health and indication,
p.(None): 4. technical, clinical, organizational and temporal data on the care process,
p.(None): 5. Data for the measurement of results (outcome),
p.(None): 6. Technical data on the implant, speci fi c implant parameters, data on the individual
p.(None): Implant setting, and
p.(None): 7. Technical, clinical, organizational, temporal and event-related data for aftercare.
p.(None): (3) The implanting / treating institutions of the healthcare system are, if this is the
p.(None): Protection of the health and safety of patients is required, the obligations mentioned in paragraph 2 and
p.(None): Personal Austria data required for the purposes of keeping the register
p.(None): to be submitted online. The granting of access to health care facilities is
p.(None): clearly documented by Gesundheit Österreich GmbH.
p.(None): (4) The Federal Minister for Health, Family and Youth has set up implant registers
p.(None): and to specify the speci fi c data sets for the individual registers by ordinance. In this
p.(None): Regulation are also the specific processing purposes and the respective processing purpose
p.(None): to set appropriate access rights.
p.(None): (5) Personal data must be pseudonymized immediately. When processing data according to
p.(None): Paragraphs 1 and 2 are for patient identification only the use of the area-speci fi c
p.(None): Personal identifier GH and AS (Section 10 Paragraph 2 E-Government Act, Federal Law Gazette I № 10/2004) permitted. The
p.(None): Area-specific personal identifiers AS may only be used and saved in encrypted form
p.(None): become. The direct personal reference must be irreversibly deleted immediately after conversion.
p.(None): (6) The area-specific personal identifiers are to be deleted as soon as they are used for the purposes
p.(None): Paragraph 1 are no longer required. The Federal Statistics Austria has health Austria
p.(None): GmbH - at their request - personal data on the time of death and the cause of death of
p.(None): To transmit persons whose data are stored in an implant register in accordance with paragraph 1.
p.(None): (Note: Paragraph 7 repealed by Art. 47 Z 29, Federal Law Gazette I No. 37/2018)
p.(None): (8) The managing director of Gesundheit Österreich GmbH has to ensure that the clear
p.(None): Identity and role of those authorized to access the state of the art for each access
p.(None): be proven and recorded. He must ensure that the appropriate state of the art
p.(None): Technically appropriate precautions are taken in order to destroy or change the data
p.(None): prevent program errors (viruses) and to destroy, change or query the
...
p.(None): assign the individual users of Gesundheit Österreich GmbH individually. The authorized users of the
p.(None): Gesundheit Österreich GmbH are aware of the provisions of the General Data Protection Regulation and that
p.(None): To teach data security concept. These access rights are deprived of their access rights,
p.(None): if they no longer need them for the further fulfillment of the tasks assigned to them or they
p.(None): Do not process data in accordance with its intended purpose.
p.(None): (13) The managing director of Gesundheit Österreich GmbH has through organizational and technical
p.(None): Precautions to ensure that access to rooms in which the database server is located
p.(None): In principle, only those with access to access from Health Austria GmbH are possible.
p.(None): (14) If the database server is removed from the area of Gesundheit Österreich GmbH, the
p.(None): Managing Director of Gesundheit Österreich GmbH ensure that unauthorized use
p.(None): is excluded.
p.(None): (15) The marketers of implants that are kept in registers according to paragraph 1 are
p.(None): undertakes to provide the technical data of your health implants required for the purposes of the register
p.(None): Österreich GmbH in electronic form.
p.(None): Traceability of medical devices
p.(None): Section 73b. The Federal Minister of Health, Family and Youth, insofar as this is in view of the
p.(None): Protect the health and safety of patients, users or third parties and avert risks
p.(None): is required considering types, groups or classes of medical devices with increased
p.(None): Risk potential through regulation for those responsible for placing medical devices on the market and
p.(None): Health care institutions for appropriate preventive measures and measures with regard to the
p.(None): Commit to traceability of medical devices while making determinations about
p.(None): 1. The types, groups or classes of medical devices that depend on the requirements of the
p.(None): Traceability are captured
p.(None): 2. the product- or product group-specific requirements regarding traceability as well
p.(None): with regard to the type, content, specificity and availability of the necessary records,
p.(None): and
p.(None): 3. the way of setting up suitable implant registers in facilities of the
p.(None): Healthcare and the necessary records.
p.(None): observational
p.(None): Section 74. The Federal Minister of Health and Consumer Protection may consider
p.(None): serious interests of public health and with a view to gaining improved
p.(None): Knowledge about the benefit / risk assessment of certain types or groups of medical devices,
p.(None): in particular also about the long-term effects of implantable medical devices that can only be
p.(None): systematic data collection and evaluation can be obtained, prescribe by regulation,
p.(None): that relevant data that has been collected in connection with the use of these medical devices and
p.(None): for the acquisition of these findings are necessary for a central evaluation
...
p.(None): Provisions are concerned, and with regard to § 99 paragraph 1, as far as commercial law concerns
p.(None): are concerned, the Federal Minister of Health and Consumer Protection in agreement with the
p.(None): Federal Minister for Economic Affairs and
p.(None): 4. with regard to Section 98 (1) of the Federal Minister of Health and Consumer Protection in
p.(None): Agreement with the Federal Minister for Economic Affairs
p.(None): entrusted.
p.(None): (2) Before enacting ordinances in accordance with this federal law, those responsible pursuant to para
p.(None): Federal Minister to hear an advisory council, which, in addition to experts in the field of regulation
p.(None): In any case, a representative of the Federal Ministry of Economics and Labor, the
p.(None): Federal Ministry of Social Affairs and Consumer Protection, the Austrian Medical Association, the
p.(None): Austrian Chamber of Dentists, the Federal Chamber of Labor, the Austrian Chamber of Commerce, the
p.(None): Austrian Chamber of Pharmacists, the main association of Austrian social security institutions, the
p.(None): Austrian Agency for Health and Nutritional Security GmbH, business unit PharmMed, and
p.(None): belong to the Austrian Seniors' Council. Furthermore, they are according to the state law
p.(None): Implementing provisions for § 11e of the Federal Act on Hospitals and Health Centers (KAKuG)
p.(None): existing patient representative bodies are entitled to send a representative.
p.(None): (3) The advisory board according to paragraph 2 is chaired by an employee of the Federal Ministry of Health,
p.(None): Family and youth, the work of the Advisory Board is carried out by the Federal Minister of Health, Family
p.(None): and youth led to rules of procedure to be adopted. In any case, it should be provided in this case
p.(None): the advisory board may be referred to in a circular manner with particular urgency or less importance.
...
Social / education
Searching for indicator education:
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p.(None): performance-related properties and the effects on the patient are examined.
p.(None): (5) The for the collection of security-related features, benefits and side effects of a
p.(None): Medical device criteria and test variables must be used with suitable observation and
p.(None): Measuring methods are determined and with regard to the assessment of the benefit / risk ratio
p.(None): be meaningful.
p.(None): (6) The procedure for carrying out a clinical trial must depend on the candidate
p.(None): Medical device to be adapted.
p.(None): (7) Clinical trials must be carried out under the intended conditions of use of the medical device
p.(None): be performed.
p.(None): (8) All serious adverse events must be fully registered by the sponsor and
p.(None): immediately to the Federal Office for Safety in Health Care and the competent authorities of the
p.(None): other relevant EEA Contracting Parties in which the clinical trial is being conducted.
p.(None): Documentation, documents
p.(None): § 43. For each clinical trial are those for the objective, the medical, scientific and
p.(None): technical basics, planning, organization, implementation and evaluation of the clinical trial
p.(None): and beyond for the protection of health, safety, integrity and rights of the
p.(None): Test takers relevant points of view and arrangements in appropriate documentation and
p.(None): To record documents.
p.(None): § 44. In particular, the following documentation and documents must be provided for every clinical trial
p.(None): and submit it to the Federal Office for Safety in Health Care:
p.(None): 1. the test plan,
p.(None): 2. the clinical investigator's manual,
p.(None): 3. those for the education of the test participants and, if applicable, their legal representatives in accordance with
p.(None): Section 51 information to be used and the declaration of consent,
p.(None): 4. the provisions for insurance protection within the meaning of sections 47 and 48,
p.(None): 5. The agreements between the sponsor, monitor and clinical investigator, the
p.(None): Define responsibilities,
p.(None): 6. The opinions of all ethics committees to be dealt with and the points of view that matter
p.(None): of these comments were, and
p.(None): 7. the final report.
p.(None): test plan
p.(None): § 45. (1) A written agreement between the sponsor and
p.(None): clinical investigator.
p.(None): (2) The test plan has the scientifically sound structure and sequence of the clinical test
p.(None): and their scientific significance with regard to their objectives and questions
p.(None): sure.
p.(None): final report
p.(None): § 46. (1) For each clinical trial, a written final report is to be prepared, which is available to everyone on the
p.(None): Clinical investigators involved must be signed.
p.(None): (2) The final report has received a critical evaluation of all those obtained during the clinical trial
p.(None): contain scientifically relevant data.
p.(None): insurance
p.(None): Section 47. (1) The sponsor has personal injury insurance taking into account paragraph 2
p.(None): complete that covers all damage to life or health of the subject by the
p.(None): clinical trial measures carried out on him and for which the
p.(None): clinical investigators would be liable if they were at fault (§ 1295 ABGB), with the exception of damage
p.(None): due to changes in genetic material in human germline cells.
p.(None): (2) Personal injury insurance in accordance with paragraph 1 is based on the following principles
p.(None): complete:
p.(None): 1. The sponsor has policyholders, the test participant has independent entitlement
p.(None): To be insured.
p.(None): 2. Austrian law must apply to the insurance contract.
p.(None): 3. The insurance claims must be enforceable in Austria.
p.(None): 4. The enforceability of an Austrian execution title abroad must, if necessary
p.(None): be secured.
p.(None): 5. The scope of insurance must be proportionate to that with the clinical
p.(None): Testing related risks; the minimum sum insured is regulated by the
p.(None): Federal Minister of Health and Consumer Protection.
p.(None): (3) The test participant and, in the cases of § 51, his legal representative are before the start of the
p.(None): to inform the clinical trial about the insurance protection in accordance with paragraphs 1 and 2.
p.(None): Section 48. In the event that the sponsor is not the clinical investigator at the same time, the sponsor must clarify:
p.(None): if necessary, whether the clinical investigator has sufficient liability and legal protection insurance
p.(None): the clinical investigator from the increased risk associated with the clinical trial
p.(None): Appropriate reimbursement of additional costs for own insurance or suitable ones for your own account
p.(None): Take out insurance for the benefit of the clinical investigator.
p.(None): Education and consent
p.(None): Section 49. (1) The clinical trial of a medical device may only be carried out if the
p.(None): Exam participants by a doctor or dentist about purpose, meaning, scope, benefits, risks and
p.(None): Of the clinical trial has been cleared and his consent to participate in the
p.(None): clinical trial.
p.(None): (2) The information must be sufficiently clear and easily understandable for the test participant, so that
p.(None): the decision to consent to participation in the clinical trial with full knowledge of the
p.(None): relevant facts.
p.(None): (3) The information must be given both verbally and in writing. She has to make it clear
p.(None): that a refusal to participate in the clinical trial or withdrawal from the clinical trial
p.(None): Examination at any time without adverse consequences, especially for further medical
p.(None): Care of the test subject remains. If necessary, the information must also include which ones
p.(None): medical consequences of withdrawing from the clinical trial at certain times.
p.(None): (4) The test participants are aware of the purpose and scope of the collection and use
p.(None): to inform personal data. The test participants are particularly keen on this
p.(None): point out that data
p.(None): 1. checked by the monitor, during an audit and during an inspection by the authority
p.(None): can be, and
p.(None): 2. passed on to the sponsor in pseudonymized form.
p.(None): (5) With the consent to take part in the clinical trial according to § 50 para
...
p.(None): and 2 listed members of the ethics committee are not allowed to have clinical examiners in the frame
p.(None): the clinical trial to be assessed.
p.(None): Section 59. (1) The members of the Ethics Committee and their deputies must perform this function
p.(None): be free of instructions. You have any relationships with manufacturers or distributors of medical devices
p.(None): completely open to the governor. They have become active in the
p.(None): Ethics Committee - without prejudice to any other reasons for bias - in all matters
p.(None): contain, in which such a relationship is likely to question its full impartiality.
p.(None): (1a) Internal quality assurance measures shall be provided within the framework of the organization
p.(None): Ensure in particular the regularity of the processes and procedures.
p.(None): (2) The implementation of the agendas of the ethics committee and the proper establishment
p.(None): Its decisions and statements must be set out in writing in the rules of procedure, which of the
p.(None): Approval by the responsible governor is required.
p.(None): (3) The sponsor or clinical investigator has all the necessary documents for the ethics committee
p.(None): Assessment of the clinical trial in accordance with § 43, in particular also evidence of qualifications, the trial plan,
p.(None): the evidence of the technical safety of the medical device, the preclinical documents, the
p.(None): Results of the benefit / risk analysis, the materials for the education of the test participants and for the
p.(None): Obtaining your consent and documents about the insurance in accordance with §§ 47 and 48 and about the
p.(None): Submit compensation for the participation of the test participants.
p.(None): § 60. (1) The responsible ethics committee has in particular based on the submitted documents
p.(None): judge:
p.(None): 1. the suitability of clinical investigators with regard to their professional qualifications and experience,
p.(None): 2. existing facilities as well as staffing and qualifications,
p.(None): 3. the test plan with regard to the objective of the test, the medical technology and medical
p.(None): Justification of the examination and with regard to its scientific significance and the
p.(None): Assessment of the benefit / risk ratio,
p.(None): 4. Selection and recruitment of the test participants as well as clarification and obtaining consent
p.(None): to participate and
p.(None): 5. the precautions for the occurrence of a claim, particularly with regard to
p.(None): Insurance taken out in accordance with sections 47 and 48 in connection with the clinical trial
p.(None): were.
p.(None): (2) The ethics committee has its opinions with reference to the submitted documents
p.(None): to be recorded in written form. The opinion on a clinical trial is within
p.(None): 60 days to submit an opinion on a change to the test plan within 35 days and
p.(None): to be transmitted to the Federal Office for Safety in Health Care at the same time.
...
Social / employees
Searching for indicator employees:
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p.(None): (2) The Federal Office for Safety in Health Care may also make determinations in accordance with para
p.(None): carry out for office. The delimitation and classification advisory board can also provide an expert opinion
p.(None): obtain according to § 5b.
p.(None): (3) The costs for expert opinions are to be borne by the applicant.
p.(None): Delimitation and classification advisory board
p.(None): § 5b. (1) To advise the Federal Minister of Health and the Federal Office for Safety in the
p.(None): Health care in questions of the delimitation of medical devices from other products as well as
p.(None): Preparation of expert reports on whether a product fulfills one of the definitions according to § 2 Paragraphs 1 to 6 and
p.(None): if necessary via the classification of the medical device, is in the Federal Ministry of Health
p.(None): Advisory Board (delimitation and classification advisory board).
p.(None): (2) In order to clarify delimitation questions from medical devices to medicinal products, the Advisory Board must
p.(None): Paragraph 1 in a joint meeting with the Commission (delimitation advisory board) in accordance with Section 49a AMG.
p.(None): (3) The Federal Minister of Health has technically suitable persons as permanent members for the
p.(None): To be ordered for a period of five years. When it comes to the composition, care should be taken that a
p.(None): balanced composition with regard to those that can be delimited and classified
p.(None): Products or product groups is guaranteed.
p.(None): (4) The deliberations of the delimitation and classification advisory board can, depending on the type of
p.(None): subject to be treated in individual cases as non-permanent members
p.(None): People are involved.
p.(None): (5) The Federal Minister of Health has one of his employees for the period specified in paragraph 3
p.(None): Ministry to chair the delimitation and classification advisory board.
p.(None): (6) A deputy must be appointed for each member and the chairman.
p.(None): (7) All members as well as the chairman and their deputies have a casting vote.
p.(None): Representatives have such a right to vote only if the persons they represent are prevented.
p.(None): (8) The work of the delimitation and classification advisory board is carried out by the Federal Minister for
p.(None): Health led by rules of procedure.
p.(None): (9) The activity in the delimitation and classification advisory board is voluntary, without prejudice to paragraph 10.
p.(None): Any travel expenses are the members of the delimitation and classification advisory board, their deputies
p.(None): and consulted experts according to the highest fee level of the travel fee regulation 1955, BGBl.
p.(None): No. 133 to replace on request.
p.(None): (10) The members of the delimitation and classification advisory board, which are appointed by the Federal Office for
p.(None): Health care was entrusted with the preparation of relevant expert reports
p.(None): adequate compensation in terms of effort and time, which the
p.(None): Applicant has to bear.
p.(None): II. MAIN PIECE
p.(None): Section 1
p.(None): Medical device requirements
p.(None): Requirements for placing on the market and commissioning
p.(None): § 6. It is forbidden to place medical devices on the market, to set them up, to install them, to put them into operation
p.(None): take or apply if
p.(None): 1. there is reasonable suspicion that they meet the basic requirements within the meaning of sections 8 and 9
p.(None): and a regulation according to § 10 or, if applicable, does not meet the requirements of § 11 or
p.(None): 2. their expiry date has passed.
...
p.(None): Persons, especially the sponsor, clinical investigator and monitor, must be specified in writing and by
p.(None): to confirm their signatures.
p.(None): (2) The clinical investigator and the monitor assume the role of sponsor
p.(None): The sponsor is permitted if this is documented and the respective responsibilities and
p.(None): Tasks are fully taken over.
p.(None): Tasks and areas of responsibility of the sponsor
p.(None): Section 63. (1) The sponsor has the clinical investigator, taking into account his professional quali fi cation,
p.(None): its availability over the entire period of the study and taking into account suitability and
p.(None): Availability of local, medical, and clinical trials available to clinical investigators
p.(None): organizational circumstances and options.
p.(None): (2) If necessary, the sponsor is responsible for appropriate monitoring of the clinical trial
p.(None): to care. For this purpose, he has one or more suitably trained and qualified people with the function
p.(None): to entrust a monitor in accordance with Section 65 or their areas of responsibility and responsibilities themselves
p.(None): perceive. Furthermore, he has to ensure that, if necessary, internal audits of the study are carried out
p.(None): can be.
p.(None): (3) The sponsor has the clinical investigator all for the safe use of the investigated
p.(None): Medical device and the proper execution of the clinical trial required documents,
p.(None): including the relevant information that will only become available during the ongoing study on
p.(None): To provide administrative support, supportive support if necessary
p.(None): Provide research staff and, if necessary, appropriate training for the clinical investigator
p.(None): and its employees in the intended and safe installation, preparation and application of the
p.(None): Medical device and its necessary accessories.
p.(None): (4) The sponsor must ensure that neither the test participant nor the
p.(None): Austrian social security institutions or third parties from providing the clinical trial
p.(None): certain medical device costs, unless
p.(None): 1. the use of which is associated with a primary individual benefit insofar as it serves to ward off one
p.(None): damage to health or to remedy physical suffering is urgently needed
p.(None): and compared to available medical devices that are already permitted on the market
p.(None): seriously increases the chances of success,
p.(None): 2. the social security institution or third parties information about the medical device used and
p.(None): the clinical trial has been made available and
p.(None): 3. Social insurance institutions or third parties based on these documents after assessing the existence
p.(None): have agreed to the requirements of sections 1 and 2 of an application for cost coverage.
p.(None): (5) The sponsor must assess the test plan and confirm it with his signature.
p.(None): (6) The sponsor may carry out its duties or obligations in whole or in part
p.(None): delegate to external scientific institutions.
p.(None): Tasks and responsibilities of the clinical investigator
p.(None): § 64. (1) Clinical investigator may only be a suitably qualified, for independent practice of
p.(None): medical or dental profession in Austria may be a qualified doctor or dentist who
p.(None): 1. is trained and experienced in the area of application of the medical device to be tested and
p.(None): 2. is familiar with the background and requirements of the clinical trial and at least one
p.(None): can demonstrate two years of experience in clinical trials.
p.(None): (2) Before the start of the clinical trial, the clinical investigator must have all relevant data and
p.(None): Documents, in particular with regard to the test plan, the relevant scientific literature, the
p.(None): preclinical data, the results of previous clinical trials with the medical device, the evidence
p.(None): about technical security, the documents about structure, composition, functionality,
p.(None): Properties and performance of the medical device and the instructions for its intended use
p.(None): Familiarize application thoroughly. The sponsor has access to all of the clinical investigator
p.(None): to ensure relevant data.
p.(None): (3) The clinical investigator must ensure that he and his employees also with regard to the
p.(None): Human resources and the available facilities and medical facilities in
p.(None): are able to conduct the clinical trial in accordance with this federal law and the trial plan and
p.(None): complete. This also includes arrangements for emergency measures.
p.(None): (4) The clinical investigator is responsible for the clarification and information required by this Federal Act
p.(None): the test participant and, if applicable, their legal representatives and obtaining the necessary
p.(None): Responsible consent.
p.(None): (4a) The clinical investigator has for the sponsor the obligations under Art. 13, 15, 16 and 18 of the data protection
p.(None): To comply with the basic regulation and in the event of violations of the protection of personal data
p.(None): Notify test takers in accordance with Art. 34 of the General Data Protection Regulation and the sponsor
p.(None): to inform about it.
p.(None): (5) The clinical investigator has the sponsor about all medical device side effects and all
p.(None): to report serious adverse events as part of the clinical trial.
p.(None): (6) The clinical investigator must sign the test plan and in writing and with his signature
p.(None): confirm that he is conducting the clinical trial in accordance with the study plan and the provisions of this
p.(None): Federal law will implement.
p.(None): (7) The clinical investigator has all employees who are involved in the conduct of the clinical trial or in the
p.(None): Care of the test participants are involved, all relevant information is available to them
p.(None): put.
p.(None): Tasks and areas of responsibility of the monitor
p.(None): Section 65. (1) The monitor has
p.(None): 1. Establish communication between sponsor and clinical investigator and on behalf of the
p.(None): To provide sponsors with appropriate monitoring of the clinical trial,
p.(None): 2. Work according to the Standard Working Instructions (SOP) before the clinical investigator
p.(None): and visit after completing the clinical trial to ensure adherence to the trial plan
p.(None): check and ensure that all data is correctly and completely recorded and recorded
p.(None): be, and
p.(None): 3. Compare the entries in the test sheets with the original findings and the clinical investigator
p.(None): to inform about errors and omissions.
p.(None): (2) The monitor must have the quali fi cations that enable it to provide expert clinical support
p.(None): Enable testing.
p.(None): Section 65a. (1) The provisions of sections 39, 40 subsection 1, 3, 4, 5 and 7, 40a and 40b, 41 to 44, 45 subsection 2, 46 bis
p.(None): 64 also apply to performance appraisal examinations, unless paragraph 2 specifies otherwise.
p.(None): (2) Unless an after-performance test of an in vitro diagnostic medical device
p.(None): Type or amount of special sampling from subjects or additional medical
p.(None): Examinations or treatments are provided or as part of the performance evaluation test
p.(None): performed in vitro diagnostic or therapeutic consequences for the
p.(None): Exam participants may have, §§ 47 to 54 do not apply to the performance assessment examination of in-
p.(None): vitro diagnostics.
p.(None): statutory authorization
p.(None): § 66. The Federal Minister of Labor, Health and Social Affairs has, provided this with regard to the
...
p.(None): to refer to specific people, their clear identity and scope of health justification
p.(None): Österreich GmbH must be proven.
p.(None): (6) When processing data in accordance with paragraphs 1 and 2, the patient must be used to identify the patient
p.(None): Name and area-speci fi c personal identifier GH and AS (§ 10 para. 2 E Government
p.(None): Law, Federal Law Gazette I № 10/2004) is permitted. The area-speci fi c personal identifier AS may only be in
p.(None): encrypted form can be used and saved. The direct personal reference is from
p.(None): Delete the responsible person immediately, irreversibly, as soon as he does not do so for the purposes of paragraph 1 nos. 1 and 3
p.(None): more is needed.
p.(None): (7) Gesundheit Österreich GmbH is entitled to the Federal Statistical Office Austria
p.(None): Request information on the time of death and the cause of death of persons whose data are in the
p.(None): Registers are processed.
p.(None): (8) The managing director of Gesundheit Österreich GmbH has to ensure that identity and role
p.(None): the person authorized to access with each access is proven according to the state of the art and
p.(None): be logged. He must ensure that the appropriate state-of-the-art technology is used
p.(None): Precautions are taken to prevent the data from being destroyed or changed
p.(None): Prevent program errors (viruses) in order to destroy, change or query the data of the
p.(None): Prevent registers by unauthorized users or systems. Furthermore, he must ensure that everyone
p.(None): processing operations carried out, such as in particular entries, changes, queries and
p.(None): Submissions that are traceable. He has to create a data security concept for the employees
p.(None): Health Austria GmbH is binding.
p.(None): (Note: Paragraphs 9 and 10 repealed by Art. 47 Z 18, Federal Law Gazette I No. 37/2018)
p.(None): (11) Gesundheit Österreich GmbH may apply to those processed or to be processed in the register
p.(None): Data
p.(None): 1. basically only in pseudonymized form,
p.(None): 2. to exercise the rights of the persons concerned in accordance with Chapter 3
p.(None): Basic regulation but also in a directly personal form
p.(None): access. For scientific purposes, Gesundheit Österreich GmbH may only use a pseudonym
p.(None): Access form.
p.(None): (12) The health care institutions participating in the registers may
p.(None): 1. For the purposes of paragraph 1 no. 3, all data relating to this person in the register also in
p.(None): access personal form if this is part of a specific treatment situation of the
p.(None): each person is required
p.(None): a) with the express consent of the data subject, or
p.(None): b) if it is impossible to obtain consent, in the vital interest of those concerned
p.(None): Person, and
p.(None): 2. for scientific purposes (para. 1 no. 6) in pseudonymized form to those processed in the register
p.(None): Access data.
p.(None): (13) The Federal Office for Safety in Health Care is for the purposes of medical device vigilance
p.(None): authorized to access the data processed in the register in personal form, provided that this is in the
...
Social / gender
Searching for indicator gender:
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p.(None): Survivors with regard to the importance of the medical device for enforcement
p.(None): Preserve liability claims.
p.(None): (2) Agreements through which healthcare facilities perform their obligations
p.(None): hindered in accordance with paragraph 1 are void.
p.(None): Section 4
p.(None): Implant register, traceability of medical devices;
p.(None): observational
p.(None): Pacemaker, ICD, loop recorder registers
p.(None): § 73. (1) Gesundheit Österreich GmbH is entitled to
p.(None): 1. for the purpose of protecting the health and safety of patients, users or third parties and
p.(None): to ward off risks associated with pacemaker implants,
p.(None): implantable defibrillators and loop recorders,
p.(None): 2. for the purpose of medical device vigilance and market surveillance related
p.(None): Pacemakers, implantable defibrillators and loop recorders,
p.(None): 3. for the purpose of quality-assured treatment in connection with the corresponding
p.(None): implantations
p.(None): 4. for the purpose of quality assurance of pacemakers, implantable defibrillators and loop devices
p.(None): recorders,
p.(None): 5. for the purpose of statistics as a basis for planning, quality assurance and quality reporting
p.(None): in Austrian healthcare and
p.(None): 6. for scientific purposes
p.(None): maintain a register for pacemakers, implantable defibrillators and loop recorders. The
p.(None): Gesundheit Österreich GmbH is responsible for the register.
p.(None): (2) The following data categories are processed in the register:
p.(None): 1. Data on the implanting / treating healthcare facility (name of the
p.(None): implanting / treating institution or name of the treating doctor,
p.(None): Hospital number, contact details),
p.(None): 2. Data on patient identification (name, gender, date of birth, social security number,
p.(None): Contact details, area-specific personal identifier),
p.(None): 3. if applicable, death data (date, cause of death, autopsy status),
p.(None): 4. relevant clinical data on medical history, current state of health and indication
p.(None): (Pre-intervention, symptoms, etiology, preoperative cardiac rhythm),
p.(None): 5. Technical, clinical, organizational and temporal data on the care process (surgeon,
p.(None): Implantation data of the medical devices and the associated probes, date of implantation,
p.(None): Localization of medical devices, access, secondary prophylaxis),
p.(None): 6. Technical data on the implant, speci fi c implant parameters, data on the individual
p.(None): Implant setting (model, manufacturer and serial number of the medical devices and the
p.(None): associated probes, implant parameters), and
p.(None): 7. Technical, clinical, organizational, time and event-related data for aftercare
p.(None): (technical and clinical control data of the implanted medical devices and the associated
p.(None): Probes, functional status, date and indication of the control, complications, explant date,
p.(None): Explantationsgrund).
p.(None): (3) The implanting / treating health facilities are in accordance with paragraph 4
p.(None): obligates the personal data types of Gesundheit Österreich GmbH mentioned in paragraph 2 online
p.(None): to transmit.
p.(None): (4) The transmission according to paragraph 3 is only permitted if the data subjects
p.(None): 1. About processing for the purposes of the pacemaker, ICD, or loop recorder register
p.(None): have been informed and
p.(None): 2. have expressly consented to this processing.
p.(None): If the consent is withdrawn during a follow-up contact, the person concerned must be informed that
...
p.(None): Precautions to ensure that access to rooms in which the database server is located
p.(None): In principle, only those with access to access from Health Austria GmbH are possible.
p.(None): (16) If the database server is removed from the area of Gesundheit Österreich GmbH, the
p.(None): Managing Director of Gesundheit Österreich GmbH ensure that unauthorized use
p.(None): is excluded.
p.(None): (17) The marketers of medical devices that are used in pacemaker, ICD, loop recorder
p.(None): Registers are kept, the technical data required for the purposes of the register are required
p.(None): to provide their implants to Gesundheit Österreich GmbH in electronic form.
p.(None): (Note: Paragraph 18 repealed by Art. 47 Z 24, Federal Law Gazette I No. 37/2018)
p.(None): implant register
p.(None): Section 73a. (1) Gesundheit Österreich GmbH is entitled to
p.(None): 1. for the purpose of protecting the health and safety of patients, users or third parties and
p.(None): to ward off risks from implantable medical devices,
p.(None): 2. for the purpose of medical device vigilance and market surveillance of implantable
p.(None): Medical devices,
p.(None): 3. for the purpose of quality assurance of implantable medical devices,
p.(None): 4. for the purpose of statistics as a basis for planning, quality assurance and quality reporting
p.(None): in Austrian healthcare and
p.(None): 5. for scientific purposes
p.(None): Implant register for active implantable medical devices, soft tissue implants, cardiovascular,
p.(None): to carry neurological and orthopedic implants.
p.(None): (2) The following data categories can be processed in the registers:
p.(None): 1. patient identification (year of birth, gender, area-specific personal identifier),
p.(None): 2. Data about the implanting healthcare facility, in particular for its identification,
p.(None): 3. relevant clinical data on medical history, current state of health and indication,
p.(None): 4. technical, clinical, organizational and temporal data on the care process,
p.(None): 5. Data for the measurement of results (outcome),
p.(None): 6. Technical data on the implant, speci fi c implant parameters, data on the individual
p.(None): Implant setting, and
p.(None): 7. Technical, clinical, organizational, temporal and event-related data for aftercare.
p.(None): (3) The implanting / treating institutions of the healthcare system are, if this is the
p.(None): Protection of the health and safety of patients is required, the obligations mentioned in paragraph 2 and
p.(None): Personal Austria data required for the purposes of keeping the register
p.(None): to be submitted online. The granting of access to health care facilities is
p.(None): clearly documented by Gesundheit Österreich GmbH.
p.(None): (4) The Federal Minister for Health, Family and Youth has set up implant registers
p.(None): and to specify the speci fi c data sets for the individual registers by ordinance. In this
p.(None): Regulation are also the specific processing purposes and the respective processing purpose
p.(None): to set appropriate access rights.
p.(None): (5) Personal data must be pseudonymized immediately. When processing data according to
p.(None): Paragraphs 1 and 2 are for patient identification only the use of the area-speci fi c
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): main intended effect is based on the abusive composition of the drug and that
p.(None): is intended for use in this connection only and is not reusable
p.(None): this product the drug law. The Federal Office for Safety in Health Care has at
p.(None): Assessment of the medical device part the basic requirements according to the II
p.(None): Federal law to apply, insofar as safety and performance-related medical device functions
p.(None): are affected.
p.(None): (3) Contains a medical device - with the exception of in vitro diagnostic medical devices - as an integrated component
p.(None): Sto ff, which - used separately - as a medicinal product within the meaning of the Medicinal Products Act and in addition to
p.(None): the medical device can have an effect on the human body, it is a
p.(None): Medical device in the sense of this federal law.
p.(None): (4) If a medical device contains a derivative of human blood as part of Section 2
p.(None): Paragraph 5c, this medical device is also subject to this federal law.
p.(None): Approval procedure
p.(None): § 5a. (1) The Federal Office for Safety in Health Care has at the request of a manufacturer or
p.(None): its authorized representative in the event that a product is intended to be placed on the market for the first time
p.(None): to determine whether this product fulfills one of the definitions according to § 2 Paragraphs 1 to 6 and, if necessary, via
p.(None): to decide on the classification and classi fi cation of the medical device. The manufacturer or
p.(None): whose authorized representative is domiciled in Germany. As part of this procedure, there may be an opinion
p.(None): Obtain the delimitation and classification advisory board in accordance with § 5b.
p.(None): (2) The Federal Office for Safety in Health Care may also make determinations in accordance with para
p.(None): carry out for office. The delimitation and classification advisory board can also provide an expert opinion
p.(None): obtain according to § 5b.
p.(None): (3) The costs for expert opinions are to be borne by the applicant.
p.(None): Delimitation and classification advisory board
p.(None): § 5b. (1) To advise the Federal Minister of Health and the Federal Office for Safety in the
p.(None): Health care in questions of the delimitation of medical devices from other products as well as
p.(None): Preparation of expert reports on whether a product fulfills one of the definitions according to § 2 Paragraphs 1 to 6 and
p.(None): if necessary via the classification of the medical device, is in the Federal Ministry of Health
p.(None): Advisory Board (delimitation and classification advisory board).
p.(None): (2) In order to clarify delimitation questions from medical devices to medicinal products, the Advisory Board must
p.(None): Paragraph 1 in a joint meeting with the Commission (delimitation advisory board) in accordance with Section 49a AMG.
p.(None): (3) The Federal Minister of Health has technically suitable persons as permanent members for the
p.(None): To be ordered for a period of five years. When it comes to the composition, care should be taken that a
p.(None): balanced composition with regard to those that can be delimited and classified
p.(None): Products or product groups is guaranteed.
p.(None): (4) The deliberations of the delimitation and classification advisory board can, depending on the type of
p.(None): subject to be treated in individual cases as non-permanent members
p.(None): People are involved.
p.(None): (5) The Federal Minister of Health has one of his employees for the period specified in paragraph 3
p.(None): Ministry to chair the delimitation and classification advisory board.
p.(None): (6) A deputy must be appointed for each member and the chairman.
p.(None): (7) All members as well as the chairman and their deputies have a casting vote.
...
p.(None): 2. Meaningful results of the required non-clinical tests are available, which accordingly
p.(None): the current state of science.
p.(None): method
p.(None): Section 40. (1) The sponsor has the clinical investigations of medical devices in Appendix 6 of the
p.(None): Directive 90/385 / EEC, in Annex VIII of Directive 93/42 / EEC, for the performance assessment of in-
p.(None): in vitro diagnostic medical devices apply the procedure listed in Annex VIII to Directive 98/79 / EC.
p.(None): (2) With the clinical trial of active implantable medical devices in accordance with the directive
p.(None): 90/385 / EEC as well as class III medical devices or implantable or long-term
p.(None): Use of certain invasive medical devices of classes IIa or IIb according to directive 93/42 / EEC
p.(None): can be approved by the responsible ethics committee and reimbursed
p.(None): proper reporting to the Federal Office for Safety in Health Care is started,
p.(None): provided that the Federal Office for Safety in Health Care is not within a period of 60 days after
p.(None): proper reporting of the clinical trial, the clinical trial to protect subjects,
p.(None): public health or due to other non-existence of the requirements of section 41 (4)
p.(None): prohibited or approved the conduct of the clinical trial before this period.
p.(None): (3) With the clinical testing of medical devices in accordance with Directive 93/42 / EEC, which is not covered in paragraph 2 and
p.(None): 5, and the performance assessment tests of in vitro diagnostic medical devices according to Directive 98/79 / EC,
p.(None): that are not mentioned in paragraph 5 can, after a favorable opinion by the responsible
p.(None): Ethics Committee and reporting a proper report to the Federal Office for Security in the
p.(None): Healthcare will be started.
p.(None): (4) The notification to the Federal Office for Safety in Health Care has included in the
p.(None): to make the declaration mentioned in Paragraph 1. The documentation listed there is on
p.(None): To provide the request immediately.
p.(None): (5) With the clinical testing of medical devices in accordance with Directive 93/42 / EEC, which according to § 15 the
p.(None): If the clinical trial does not indicate a different purpose of the
p.(None): Medical device as the object of the conformity assessment and the clinical
p.(None): Testing does not require additional diagnostic or therapeutic measures - after
p.(None): approval by the responsible ethics committee. With the
p.(None): Performance assessment testing of in vitro diagnostic medical devices according to the directive 98/79 / EG, which according to § 15 the CE
p.(None): If the performance assessment test does not indicate any other purpose of the
p.(None): In-vitro diagnostics as the object of the conformity assessment - after
p.(None): approval by the responsible ethics committee. Section 47 does not apply.
p.(None): (6) The sponsor has the Federal Office for Safety in Health Care and the responsible
p.(None): Authorities of other affected EEA parties to the completion of the clinical trial, in the event of a
p.(None): early termination with a corresponding reason. This message also sent to the
p.(None): competent authorities of all other EEA contracting parties and the European Commission
p.(None): take place if the premature termination occurs for security reasons. The final report according to
p.(None): Annex 7 section 2.3.7 of Directive 90/385 / EEC or Annex X section 2.3.7 of Directive 93/42 / EEC
p.(None): is for the Federal Office for Safety in Health Care and the competent authorities of the others
p.(None): to keep the relevant EEA contracting parties available.
p.(None): (7) Reports in accordance with paragraphs 1, 2, 3 and 6, § 40b and § 42 paragraph 8 must be in accordance with a
p.(None): Regulation according to § 67 in the way of the European database for medical devices.
p.(None): Modification of the test plan
p.(None): Section 40a. (1) After the clinical trial begins, the sponsor may change the trial schedule. If the
p.(None): Change is significant and affects in particular the safety of the test participants or the
p.(None): The sponsor of clinical trials can influence the scientific significance of the clinical trial
p.(None): Examinations according to § 40 Paragraphs 2 and 3 of the Federal Office for Safety in Health Care and the
p.(None): report the content of the change and all reasons for it to the responsible ethics committee. In clinical
p.(None): The sponsor of the responsible ethics committee has the content of the change and
p.(None): to report all reasons for this.
p.(None): (2) In the case of a clinical trial pursuant to Section 40 (2), the change can be made after a positive opinion
p.(None): the responsible ethics committee for a report in accordance with paragraph 1, provided that
p.(None): Federal Office for Safety in Health Care not within a period of 35 days after
p.(None): Proper notification of the change to the clinical trial to protect the trial subject
p.(None): public health or due to other non-existence of the requirements of section 41 (4)
p.(None): prohibited or approved the implementation of the change before this period.
p.(None): (3) In the case of a clinical trial pursuant to Section 40 (3), the change can be made after a positive opinion
p.(None): the responsible ethics committee on a report in accordance with paragraph 1 and reimbursement of the report in accordance with paragraph 1
p.(None): to the Federal Office for Safety in Health Care.
p.(None): (4) In the case of a clinical trial in accordance with Section 40 (5), the change can be made after a positive opinion
p.(None): the responsible ethics committee for a report in accordance with paragraph 1.
p.(None): (5) Without prejudice to paragraphs 1 to 4, the sponsor and the clinical investigator have each new
p.(None): Circumstance regarding the course of the examination or the development of the medical device in clinical examination,
p.(None): which can impair the safety of the test participants or users, the urgently required
p.(None): Take security measures to protect test takers or users from immediate danger
p.(None): protect. In the case of clinical trials in accordance with section 40 (2) and (3), you have the Federal Office for
p.(None): Healthcare security and the responsible ethics committee on these new circumstances and the
p.(None): measures taken to inform. In the case of clinical trials in accordance with section 40 (5), they must immediately
p.(None): to inform the responsible ethics committee about these new circumstances and the measures taken.
p.(None): The notification requirements according to § 70 remain unaffected.
p.(None): Suspension or prohibition of the clinical trial
p.(None): Section 40b. (1) Provided the Federal Office for Safety in Health Care has objective reasons for acceptance
p.(None): has that the requirements of the notification according to § 40 paragraphs 2 and 3 are no longer met, or about
p.(None): Information that is relevant to the safety or the scientific basis of a
p.(None): If the clinical trial raises concerns, it must suspend or prohibit the clinical trial.
p.(None): Before the decision, except in the event of imminent danger (§ 57 AVG), the sponsor and the
p.(None): to inform clinical investigators. The sponsor must give his opinion within one week.
p.(None): (2) The Federal Office for Safety in Health Care, provided that it carries out a clinical
p.(None): Suspends or prohibits review, the other EEA Contracting Parties, the relevant ethics committee,
p.(None): and the European Commission stating the reasons for its decision to conduct the clinical trial
p.(None): suspend or prohibit, inform. Has the Federal Office for Safety in Health Care
p.(None): ordered a significant change in a clinical trial, it has the other contracting parties
p.(None): of the EEA in whose territory the clinical trial is being conducted, as well as the responsible
p.(None): To inform the ethics committee about its measures and their reasons.
p.(None): (3) Does the Federal Office for Safety in Health Care have reasons to believe that the sponsor
p.(None): or the clinical investigator or any other party involved in the clinical trial does not meet its obligations
p.(None): more fulfilled, it must inform the concerned person immediately and give him the opportunity to comment
p.(None): and then inform him of an action plan that he must implement to remedy the situation. This
p.(None): applies even if the clinical trial has already ended. Obligation to notify according to paragraph 2 remains
p.(None): unaffected.
p.(None): general requirements
p.(None): § 41. (1) When planning, setting up and carrying out clinical trials, the health
p.(None): To keep risks and burdens for the test participant as low as possible.
p.(None): (2) The clinical trial of medical devices may only be carried out if the risks associated with
p.(None): you are connected to the test participants, measured by the expected meaning of the result of the
...
p.(None): this federal law in accordance with the state of the art.
p.(None): (5) Ethics committees are obligated, the Federal Office for Safety in Health Care all
p.(None): To provide information and to send documents that this to perform its duties under this
p.(None): Section needed.
p.(None): (6) If an inspection determines that a clinical trial is contrary to the provisions of this
p.(None): Federal law is carried out, or arise concerns regarding the safety or the
p.(None): scientific basis of clinical testing and thereby the life or health of
p.(None): Exam participants or users are at risk, the Federal Office for Security in
p.(None): Healthcare measures within the meaning of Section 40b (1), even without a previous procedure or before
p.(None): Issuing a decision; however, written notification of this is to be given within two weeks
p.(None): otherwise the measure is deemed to have been lifted.
p.(None): (7) Developed by the Federal Office for Safety in Health Care on the occasion of an inspection
p.(None): clinical trial cash expenses are to be charged to the sponsor, unless the clinical
p.(None): Examiners perform the tasks of the sponsor within the meaning of Section 3 (5).
p.(None): ethics committees
p.(None): Section 57. (1) The clinical trial of a medical device may only be carried out if the
p.(None): Assessment has been obtained from the responsible ethics committee.
p.(None): (2) In the context of a multicentre examination, a responsible ethics committee can issue the opinion
p.(None): to another ethics committee responsible for this clinical trial as sufficient. In this
p.(None): Case, the assessing ethics committee must also announce all of the auditors involved and all of them
p.(None): Documents are made available that provide an assessment with regard to their professional quali fi cation
p.(None): and experience, as well as the existing facilities and staff.
p.(None): Section 58. (1) The governor has with regard to clinical trials outside of hospitals
p.(None): Ensure that independent ethics committees are responsible in the area of his state
p.(None): A sufficient number of tasks are performed in accordance with Section 60.
p.(None): (2) For clinical trials at hospitals, the responsible ethics committee in accordance with § 8c
p.(None): Hospital Act, Federal Law Gazette No. 1/1957.
p.(None): (3) The appointment of ethics committees in accordance with paragraph 1 is the Federal Ministry of Health and
p.(None): Women and the Federal Office for Safety in Health Care display.
p.(None): (4) The ethics committee must at least consist of:
p.(None): 1. a doctor who is authorized to practice his profession independently in Germany,
p.(None): 2. a specialist in whose specialty is the clinical examination of the medical device,
p.(None): 3. a representative of the nursing service,
p.(None): 4. a lawyer,
p.(None): 5. a pharmacist,
p.(None): 6. a technical safety officer of a hospital,
p.(None): 7. a patient representative,
...
p.(None): the evidence of the technical safety of the medical device, the preclinical documents, the
p.(None): Results of the benefit / risk analysis, the materials for the education of the test participants and for the
p.(None): Obtaining your consent and documents about the insurance in accordance with §§ 47 and 48 and about the
p.(None): Submit compensation for the participation of the test participants.
p.(None): § 60. (1) The responsible ethics committee has in particular based on the submitted documents
p.(None): judge:
p.(None): 1. the suitability of clinical investigators with regard to their professional qualifications and experience,
p.(None): 2. existing facilities as well as staffing and qualifications,
p.(None): 3. the test plan with regard to the objective of the test, the medical technology and medical
p.(None): Justification of the examination and with regard to its scientific significance and the
p.(None): Assessment of the benefit / risk ratio,
p.(None): 4. Selection and recruitment of the test participants as well as clarification and obtaining consent
p.(None): to participate and
p.(None): 5. the precautions for the occurrence of a claim, particularly with regard to
p.(None): Insurance taken out in accordance with sections 47 and 48 in connection with the clinical trial
p.(None): were.
p.(None): (2) The ethics committee has its opinions with reference to the submitted documents
p.(None): to be recorded in written form. The opinion on a clinical trial is within
p.(None): 60 days to submit an opinion on a change to the test plan within 35 days and
p.(None): to be transmitted to the Federal Office for Safety in Health Care at the same time.
p.(None): (3) The Ethics Committee may review the proper conduct of the clinical trial
p.(None): protecting the health and safety of test takers and maintaining their integrity and
p.(None): Check rights through an inspection at the sponsor or at the testing center.
p.(None): § 61. The clinical investigator has the ethics committee immediately on all serious
p.(None): Inform side effects in the clinical trial. The reporting obligations of Section 70 remain
p.(None): unaffected.
p.(None): Tasks and areas of responsibility of the people involved in the clinical trial
p.(None): Section 62. (1) The responsibilities and areas of responsibility of those involved in the clinical trial
p.(None): Persons, especially the sponsor, clinical investigator and monitor, must be specified in writing and by
p.(None): to confirm their signatures.
p.(None): (2) The clinical investigator and the monitor assume the role of sponsor
p.(None): The sponsor is permitted if this is documented and the respective responsibilities and
p.(None): Tasks are fully taken over.
p.(None): Tasks and areas of responsibility of the sponsor
p.(None): Section 63. (1) The sponsor has the clinical investigator, taking into account his professional quali fi cation,
p.(None): its availability over the entire period of the study and taking into account suitability and
p.(None): Availability of local, medical, and clinical trials available to clinical investigators
p.(None): organizational circumstances and options.
p.(None): (2) If necessary, the sponsor is responsible for appropriate monitoring of the clinical trial
...
General/Other / Dependent
Searching for indicator dependent:
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p.(None): Areas to be used or equipped with the same technologies.
p.(None): (1b) "Generic product group" is a group of medical devices with the same or similar
p.(None): Terms of use or with technological similarities so that they are general without
p.(None): Taking into account specific characteristics that can be classified.
p.(None): (1c) "Disposable product" is a medical device that is for single use on a single person
p.(None): is determined.
p.(None): (2) "Accessories" for a medical device are objects, materials, preparations from materials and
p.(None): Software that is not itself a medical device according to paragraph 1, according to the manufacturer's express
p.(None): specified purpose but are intended
p.(None): 1. To be used together with a medical device, so that it complies with the requirements of
p.(None): Manufacturer of the medical device specified purpose of the medical device applied
p.(None): can be, or
p.(None): 2. to support the intended purpose for the medical device.
p.(None): Accessories are considered medical devices. Accessories for active implantable medical devices are themselves considered active
p.(None): implantable medical device. Accessories for an in-vitro diagnostic device are themselves considered in-vitro diagnostic devices,
p.(None): unless the products are invasive and are intended for taking samples,
p.(None): that come into direct contact with the human body for the purpose of sampling. This
p.(None): are considered medical devices within the meaning of Directive 93/42 / EEC.
p.(None): (3) "Active medical device" is any medical device that is operated by an electrical device
p.(None): Energy source or another energy source is dependent on that directly by the human
p.(None): Body or gravity generated energy. A medical device that is used to transfer energy,
p.(None): Bumps or parameters between an active medical device and the patient is used without
p.(None): the fact that there is a significant change in energy, impact or parameters does not count as active
p.(None): Medical product.
p.(None): (4) "Active implantable medical device" is any medical device that operates on an electrical device
p.(None): Energy source or any energy source other than that directly through the human body or the
p.(None): Gravity-generated energy, and is designed to be wholly or partially by one
p.(None): surgical or other medical intervention in the human body or through a
p.(None): medical intervention to be introduced into a natural opening of the body and is intended after the
p.(None): Intervention to stay there.
p.(None): (5) "Medical device for in-vitro diagnosis" or "in-vitro diagnostic device" is any medical device that
p.(None): 1. individually or in combination as specified by the manufacturer
p.(None): a) reagent,
p.(None): b) reagent product,
p.(None): c) calibration material,
p.(None): d) control material,
p.(None): e) kit,
p.(None): f) instrument,
p.(None): g) apparatus, device or
p.(None): h) system
p.(None): for the in vitro analysis of samples from the human body, including
p.(None): Blood and tissue donation is used, and
p.(None): 2. serves solely or predominantly to
p.(None): a) Information about physiological or pathological conditions or congenital anomalies
p.(None): give or
p.(None): (b) check the safety and tolerability of the potential recipients, or
p.(None): c) monitor a therapeutic measure.
p.(None): Sample containers, evacuated or non-evacuated, by the manufacturer are also considered to be in vitro diagnostics
p.(None): especially for the in vitro analysis of samples from the human body as
...
General/Other / Natural Hazards
Searching for indicator hazard:
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p.(None): or professionally clean, disinfect or sterilize or medical devices in facilities of the
p.(None): With regard to these activities, the application or operation of health care is subject to
p.(None): Monitoring.
p.(None): (2) Monitoring within the meaning of paragraph 1 is carried out by the organs of the Federal Office for Security in the
p.(None): Healthcare, the Federal Minister of Health and Women or by commissioned by them
p.(None): Expert. The activity of relevant accredited bodies, from
p.(None): Federal Minister of Health and Women recognized organizer of proficiency tests, by operators of
p.(None): Medical device registries or other organizers from the Federal Minister of Health and Women
p.(None): recognized cross-regional comparative tests and assessments related to
p.(None): Medical devices.
p.(None): (3) Insofar as within the scope of conformity assessment procedures according to a regulation according to § 28
p.(None): Monitoring is provided, it is carried out by the for the respective conformity assessment procedure
p.(None): competent notified body. Monitoring by notified bodies is carried out in accordance with a regulation
p.(None): according to § 28.
p.(None): (4) The monitoring pursuant to Paragraph 1 can relate to all aspects that affect security,
p.(None): Functionality and quality of medical devices as well as the protection of health and safety
p.(None): Can influence patients, users or third parties.
p.(None): (5) The surveillance of health care facilities can take into account the
p.(None): The respective hazard potential is carried out systematically, on a sample basis or in the event of an incident, especially in the
p.(None): With regard to possible threats to the life or health of patients, users or third parties
p.(None): in connection with medical devices or with a view to ensuring a quality-assured
p.(None): Provision, application and maintenance of medical devices in the interest of health. Lies a
p.(None): Violation of provisions of this federal law or on the basis of decrees issued
p.(None): before, the institution must be instructed to remedy the defects within a reasonable period of time. comes
p.(None): when surveillance reveals that a violation of the provisions of this federal law or
p.(None): on the basis of enacted regulations the life and health of patients, users
p.(None): or third parties is endangered, the necessary measures to protect life and the
p.(None): Health of these people.
p.(None): (6) The monitoring of facilities and establishments by establishments, facilities or persons
p.(None): have been commissioned with the storage and transport of medical devices within the meaning of paragraph 1
p.(None): only permitted if circumstances exist which justify the assumption that medical devices are stored or
p.(None): the means of transport are misused as storage facilities via which to process the
p.(None): Transport agendas may be used beyond the time required.
p.(None): (7) The organs of the Federal Office for Safety in Health Care, the Federal Ministry for
p.(None): Health and women and the experts commissioned in accordance with paragraph 2 are authorized to
p.(None): 1. to enter and view real estate, business premises, business premises, means of transport, in
p.(None): or on which an activity according to paragraph 1 is carried out,
...
p.(None): Operators or users,
p.(None): 9. Quality management measures in manufacturing and other handling
p.(None): Medical devices,
p.(None): 10. other operational arrangements for good sales and service practice and
p.(None): 11. the keeping and storage of evidence of those relevant to medical devices
p.(None): Operations.
p.(None): (3) In a regulation pursuant to paragraph 1, provision must also be made for certain establishments to manufacture and
p.(None): Storage of and trading in medical devices may only commence after obtaining a permit
p.(None): through the Federal Office for Safety in Health Care. It can be provided
p.(None): that the permit is only for the trade or wholesale of certain species or groups of
p.(None): Medical devices is required. In a regulation according to paragraph 1, the requirements for the
p.(None): Approval insofar as this affects the safety, quality and functionality of the medical devices and the
p.(None): Safety and health of patients, users or third parties. It is on the
p.(None): Expertise, reliability and on organizational requirements to guarantee the
p.(None): To take medical device safety very seriously.
p.(None): (4) If the Federal Office for Safety in Health Care determines that in companies within the meaning of paragraph 1
p.(None): the requirements laid down in a regulation in accordance with paragraph 2 are not complied with and from them
p.(None): a not inconsiderable risk to the health and safety of patients, users or third parties
p.(None): grows up, the Federal Office for Safety in Health Care can close the business, if not through
p.(None): other measures that can be found. Performs the violation of a regulation
p.(None): in accordance with paragraph 2 of the requirements for an immediate health hazard
p.(None): these measures can also be taken without a previous procedure. However, this is within
p.(None): to issue a reasoned decision of four weeks.
p.(None): (5) The regulations in paragraphs 1 to 4 also apply to persons who meet the requirements in paragraph 1
p.(None): perform the listed activities professionally.
p.(None): Section 2
p.(None): Sales, distribution, prescription of medical devices
p.(None): Section 99. (1) The Federal Minister of Health and Consumer Protection has considered the
p.(None): Protection of the safety and health of patients, users or third parties, on ensuring the
p.(None): required quality of medical devices and taking into account the requirements for delivery,
p.(None): especially with regard to information, instruction, installation or functional testing as well as with regard to
p.(None): appropriate precautions to avert risks in agreement with the Federal Minister for Economic Affairs
p.(None): Matters through regulation stipulate that certain types of medical devices only through
p.(None): certain businesses or pharmacies may be sold or that for the delivery of the
p.(None): Medical device must be available to a person whose training and practical experience
p.(None): this regulation is established. The delivery of these medical devices and advice on this is this
p.(None): Reserved person. In this regulation, the Federal Minister of Health and Consumer Protection
p.(None): also determine that certain types of medical devices are not self-service, through vending machines
p.(None): or may be delivered by mail order.
p.(None): (2) The Federal Minister of Health and Consumer Protection has for medical devices, their
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): Science stand.
p.(None): (2) Deviating from Paragraph 1 No. 2, a clinical trial on minors is also permitted if
p.(None): 1. The clinical trial is an essential extension of the scientific understanding of the
p.(None): Condition, illness or disorder of the minor and thereby either
p.(None): Can benefit patients or the patient group to which the minor belongs, and
p.(None): 2. The clinical trial for the minor with only a minimal risk and minimal burden
p.(None): brings oneself; a clinical trial has minimal risk and minimal burden if
p.(None): it is to be expected that at most it will be a minor and merely temporary
p.(None): Impairment and any symptoms or inconveniences can be very minor
p.(None): and will only appear temporarily.
p.(None): § 52. The clinical trial may be carried out on a person who is the result of a mental illness or a
p.(None): comparable impairment of their ability to make decisions has a legal representative or on
p.(None): judicial or official order stopped or according to the Housing Act, BGBl.
p.(None): No. 155/1990, is not carried out.
p.(None): Section 52a. (1) A clinical trial, by its nature, can only be used in emergency situations in which appropriate
p.(None): Time no consent of the legal representative can be obtained, can be carried out at
p.(None): a person who is unable to consent to have a clinical trial performed if:
p.(None): 1. There are no indications that either the patient refused the clinical trial
p.(None): or would reject or the requirements of Section 52 exist,
p.(None): 2. Such research for the validation of data used in clinical trials for consent
p.(None): have been obtained by persons capable of providing information or using other research methods, and
p.(None): absolutely necessary for the clinical evaluation of the safety and effectiveness of the medical device
p.(None): are and can only be carried out in emergency situations,
p.(None): 3. the medical device that is being tested to fulfill a purpose as defined in Section 2 (1)
p.(None): Z 1 to 3 is determined in an emergency situation,
p.(None): 4. the use of the medical device that is being tested according to the knowledge of the medical
p.(None): Science is indicated to help the emergency patient
p.(None): a) to recognize, prevent, monitor, treat or alleviate an illness,
p.(None): b) identify, monitor, treat, alleviate, or alleviate an injury or disability
p.(None): compensate, or
p.(None): c) to examine, change or adapt the anatomical structure or physiological processes
p.(None): replace,
p.(None): and the patient benefit associated with inclusion in the clinical trial, the risk
p.(None): predominates
p.(None): 5. the conduct of the test and the test plan by an ethics committee that has knowledge of the
p.(None): Area of the disease concerned, in relation to the emergency situation and the affected
p.(None): Patient group or who deal with clinical and ethical issues in the field of
p.(None): related illness, in relation to the emergency situation and the affected patient group
p.(None): , expressly for the conduct of clinical trials in emergency situations on persons who
p.(None): are unable to give personal consent, have been approved, and
p.(None): 6. In case of doubt, the interests of the patient always outweigh the public interests and the interests of the patient
p.(None): Science stand.
p.(None): (2) At the test center where a clinical trial in emergency situations is performed on people who are not in
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 49 and
p.(None): 50 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Enlightenment including express consent under data protection law is given. Another
p.(None): Processing of the data processed up to that point requires the express data protection law
p.(None): Approval.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 51.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 53. The clinical trial of a medical device may be carried out on a pregnant or breastfeeding woman
p.(None): Mother can only be done when
p.(None): 1. the medical device to be tested in order to achieve a purpose in accordance with Section 2 (1)
...
p.(None): (5) The sponsor must assess the test plan and confirm it with his signature.
p.(None): (6) The sponsor may carry out its duties or obligations in whole or in part
p.(None): delegate to external scientific institutions.
p.(None): Tasks and responsibilities of the clinical investigator
p.(None): § 64. (1) Clinical investigator may only be a suitably qualified, for independent practice of
p.(None): medical or dental profession in Austria may be a qualified doctor or dentist who
p.(None): 1. is trained and experienced in the area of application of the medical device to be tested and
p.(None): 2. is familiar with the background and requirements of the clinical trial and at least one
p.(None): can demonstrate two years of experience in clinical trials.
p.(None): (2) Before the start of the clinical trial, the clinical investigator must have all relevant data and
p.(None): Documents, in particular with regard to the test plan, the relevant scientific literature, the
p.(None): preclinical data, the results of previous clinical trials with the medical device, the evidence
p.(None): about technical security, the documents about structure, composition, functionality,
p.(None): Properties and performance of the medical device and the instructions for its intended use
p.(None): Familiarize application thoroughly. The sponsor has access to all of the clinical investigator
p.(None): to ensure relevant data.
p.(None): (3) The clinical investigator must ensure that he and his employees also with regard to the
p.(None): Human resources and the available facilities and medical facilities in
p.(None): are able to conduct the clinical trial in accordance with this federal law and the trial plan and
p.(None): complete. This also includes arrangements for emergency measures.
p.(None): (4) The clinical investigator is responsible for the clarification and information required by this Federal Act
p.(None): the test participant and, if applicable, their legal representatives and obtaining the necessary
p.(None): Responsible consent.
p.(None): (4a) The clinical investigator has for the sponsor the obligations under Art. 13, 15, 16 and 18 of the data protection
p.(None): To comply with the basic regulation and in the event of violations of the protection of personal data
p.(None): Notify test takers in accordance with Art. 34 of the General Data Protection Regulation and the sponsor
p.(None): to inform about it.
p.(None): (5) The clinical investigator has the sponsor about all medical device side effects and all
p.(None): to report serious adverse events as part of the clinical trial.
p.(None): (6) The clinical investigator must sign the test plan and in writing and with his signature
p.(None): confirm that he is conducting the clinical trial in accordance with the study plan and the provisions of this
p.(None): Federal law will implement.
p.(None): (7) The clinical investigator has all employees who are involved in the conduct of the clinical trial or in the
p.(None): Care of the test participants are involved, all relevant information is available to them
p.(None): put.
p.(None): Tasks and areas of responsibility of the monitor
p.(None): Section 65. (1) The monitor has
p.(None): 1. Establish communication between sponsor and clinical investigator and on behalf of the
p.(None): To provide sponsors with appropriate monitoring of the clinical trial,
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): (9) “Ethics Committee” is an independent body composed according to Section 58 (4)
p.(None): medical experts and other members whose job it is to assess whether a
p.(None): there is a scientifically adequately substantiated clinical trial and whether the safety of that
p.(None): Wellbeing, the rights and integrity of test takers are protected.
p.(None): (10) "Clinical Trial Final Report" or "Final Report" is a complete description and
p.(None): Evaluation of the clinical trial after its completion.
p.(None): (11) “Multicentre trial” is a clinical trial that corresponds to a single clinical trial
p.(None): Test plan, but is carried out at several examination sites.
p.(None): (12) "Case report scheme" or "test sheet" is a set of documents designed in such a way that all
p.(None): relevant patient and medical device related data required by the clinical trial plan
p.(None): are fully documented.
p.(None): (13) “Audit” is the comparison of the raw data and the corresponding records with the intermediate
p.(None): or final report to determine whether the raw data have been correctly reported and evaluated and the
p.(None): clinical trial was conducted in accordance with the study plan. An audit must go through either
p.(None): an internal sponsor unit that operates independently of the clinical unit
p.(None): Research is responsible, or be carried out by an external scientific institution.
p.(None): (14) "Inspection of a clinical trial" is one by the responsible ethics committee, the Federal Office
p.(None): for safety in healthcare, by an expert commissioned by this or by a
p.(None): foreign health authority carried out check at the test center or at the sponsor who the
p.(None): Compliance with the provisions of this federal law or other regulations on the clinical investigation of
p.(None): Medical devices checked.
p.(None): (14a) "Inspection of a performance evaluation test" is one by the Federal Office for Security in the
p.(None): Health care, an expert commissioned by this or by a foreign
p.(None): Health agency conducted review of a performance assessment review that required adherence to
p.(None): Provisions of this federal law or other provisions on the performance evaluation of in vitro
p.(None): Diagnostics checked.
p.(None): (15) “Adverse event” is any adverse clinical event in a clinical event
p.(None): Exam participants included, regardless of whether it is related to the exam
p.(None): or performance-rated medical device stands or not.
p.(None): (16) An event or a side effect within the meaning of Section 2 (17) is to be classified as serious if
p.(None): that is fatal or life threatening, causes permanent damage, or requires inpatient treatment or
p.(None): Extension of the inpatient stay is necessary. Any undesirable event or any
p.(None): Medical device side effect, the damage to a fetus, its death or a congenital
p.(None): Malformation or the appearance of a malignant tumor are in any case considered to be serious
p.(None): classified.
p.(None): Section 3
p.(None): Differentiation from other regulations
p.(None): Exceptions to the scope
p.(None): § 4. (1) This Federal Act does not apply to
p.(None): 1. Medicinal products within the meaning of the Medicinal Products Act (AMG), Federal Law Gazette № 185/1983, in accordance with Section 5
p.(None): the decision as to whether a product falls under the AMG or this federal law is made
p.(None): especially due to the main mode of action of the product,
...
p.(None): Appropriate reimbursement of additional costs for own insurance or suitable ones for your own account
p.(None): Take out insurance for the benefit of the clinical investigator.
p.(None): Education and consent
p.(None): Section 49. (1) The clinical trial of a medical device may only be carried out if the
p.(None): Exam participants by a doctor or dentist about purpose, meaning, scope, benefits, risks and
p.(None): Of the clinical trial has been cleared and his consent to participate in the
p.(None): clinical trial.
p.(None): (2) The information must be sufficiently clear and easily understandable for the test participant, so that
p.(None): the decision to consent to participation in the clinical trial with full knowledge of the
p.(None): relevant facts.
p.(None): (3) The information must be given both verbally and in writing. She has to make it clear
p.(None): that a refusal to participate in the clinical trial or withdrawal from the clinical trial
p.(None): Examination at any time without adverse consequences, especially for further medical
p.(None): Care of the test subject remains. If necessary, the information must also include which ones
p.(None): medical consequences of withdrawing from the clinical trial at certain times.
p.(None): (4) The test participants are aware of the purpose and scope of the collection and use
p.(None): to inform personal data. The test participants are particularly keen on this
p.(None): point out that data
p.(None): 1. checked by the monitor, during an audit and during an inspection by the authority
p.(None): can be, and
p.(None): 2. passed on to the sponsor in pseudonymized form.
p.(None): (5) With the consent to take part in the clinical trial according to § 50 para
p.(None): obtain explicit data protection consent. The revocation of consent has none
p.(None): Effects on activities based on informed consent prior to their
p.(None): Revocation, or on the use of the data collected on this basis. The
p.(None): Law under Article 17 of the General Data Protection Regulation is excluded. This is in the course of the collection
p.(None): of consent.
p.(None): (6) For further processing in accordance with Art. 9 Para. 2 lit. j of the General Data Protection Regulation, Section 2d applies
p.(None): Paragraph 3 of the Research Organization Act, Federal Law Gazette I No. 131/2015.
p.(None): § 50. (1) If a test participant agrees to participate after extensive information, must
p.(None): his consent must be recorded in writing. The consent must be dated and with the
p.(None): Signature of the test participant. If the test participant is not in the
p.(None): Is the consent must be given before a witness who has the consent of his
p.(None): Has to confirm signature.
...
p.(None): (3) The study plan, the final report as well as all created in connection with the clinical study
p.(None): Data and documents are for specific periods after the completion or termination of the clinical trial
p.(None): to be kept by the Federal Minister of Health and Consumer Protection in a regulation pursuant to
p.(None): Section 66 are to be laid down. This regulation also specifies who is to be kept for certain
p.(None): Data or documents hits.
p.(None): (3a) For the period of the retention periods, the right under Art. 17 data protection
p.(None): Basic regulation excluded.
p.(None): (4) All data and documents relevant to the clinical trial must be submitted to the
p.(None): Federal Office for Safety in Health Care to check compliance with the provisions of this
p.(None): Federal Act on Clinical Trials will be made available.
p.(None): Quality control and quality management
p.(None): § 56. (1) The sponsor and the clinical investigator have with regard to planning, implementation and
p.(None): Evaluation of a clinical trial to apply an adequate quality management system that the
p.(None): complete traceability of all observations and findings, correct collection and processing
p.(None): data and the correct derivation of conclusions.
p.(None): (2) An audit initiated by the sponsor must be carried out by bodies or organizational units that
p.(None): are independent of those responsible for the clinical trial.
p.(None): (3) Test centers, facilities including laboratories and any kind of data are for one
p.(None): Review by the responsible ethics committee and for an inspection by the Federal Office for
p.(None): Healthcare security or by a foreign health authority upon notice
p.(None): to make it accessible.
p.(None): (4) The aim of an inspection is to determine, by means of objective, independent verification, whether the in
p.(None): this federal law prescribed standard with regard to planning, implementation and evaluation
p.(None): clinical trials are complied with. An ethics committee inspection may also aim to:
p.(None): by means of an objective, independent review to determine whether the ethics committee is performing its tasks
p.(None): this federal law in accordance with the state of the art.
p.(None): (5) Ethics committees are obligated, the Federal Office for Safety in Health Care all
p.(None): To provide information and to send documents that this to perform its duties under this
p.(None): Section needed.
p.(None): (6) If an inspection determines that a clinical trial is contrary to the provisions of this
p.(None): Federal law is carried out, or arise concerns regarding the safety or the
p.(None): scientific basis of clinical testing and thereby the life or health of
p.(None): Exam participants or users are at risk, the Federal Office for Security in
p.(None): Healthcare measures within the meaning of Section 40b (1), even without a previous procedure or before
p.(None): Issuing a decision; however, written notification of this is to be given within two weeks
p.(None): otherwise the measure is deemed to have been lifted.
p.(None): (7) Developed by the Federal Office for Safety in Health Care on the occasion of an inspection
p.(None): clinical trial cash expenses are to be charged to the sponsor, unless the clinical
p.(None): Examiners perform the tasks of the sponsor within the meaning of Section 3 (5).
...
p.(None): to support the fulfillment of their tasks. You are committed to these premises
p.(None): Medical devices and records to make the prescribed or regulatory
p.(None): to allow the ordered test, to provide the necessary staff and resources and the
p.(None): To provide information and to submit the documents necessary for the fulfillment of the tasks of the monitoring
p.(None): entrusted bodies or the experts commissioned in accordance with paragraph 2 are required.
p.(None): (9) The official acts in accordance with paragraphs 5 to 8 are, except in the event of imminent danger or if the
p.(None): there is reasonable reason to believe that the effectiveness of the official act will be impaired during the
p.(None): Carry out operating times and announce them in advance. The organs and the experts according to paragraph 2
p.(None): in their surveillance activities must take care that each is not absolutely necessary
p.(None): Disruption or hindrance to the activities of companies, facilities or persons in accordance with paragraph 1
p.(None): is avoided.
p.(None): (10) The Federal Minister of Health and Women has an appropriate perspective
p.(None): and effective control for the following calendar year a directive on the implementation of the
p.(None): To issue inspections (inspection plan). The Federal Office for Safety in Health Care has under
p.(None): Compliance with this guideline and the Federal Ministry of Health and Women by
p.(None): Report on the execution on March 31 of the following calendar year.
p.(None): (11) Market surveillance authority within the meaning of Regulation (EC) № 765/2008 of the European
p.(None): Parliament and of the Council of 9 July 2008 on the rules for accreditation and
p.(None): Market surveillance in connection with the marketing of products and the lifting of
p.(None): Regulation (EEC) № 339/93 for products within the meaning of this federal law is the Federal Office for
p.(None): Healthcare security.
p.(None): (12) The Federal Office for Safety in Health Care has in accordance with the requirements of
p.(None): Federal Ministry of Health to create market surveillance programs for medical devices and
p.(None): to update and carry out regularly. These are for the Federal Minister of Health
p.(None): To submit approval. The Federal Office for Safety in Health Care has these programs
p.(None): to other Member States and the European Commission and to the public by means of
p.(None): to provide electronic means of communication and, if necessary, by other means.
p.(None): (13) The Federal Ministry of Health has the functioning of the market surveillance activity of the
p.(None): Federal Office for Safety in Health Care regularly, but at least every four years
p.(None): review and evaluate. The results of these reviews are the other Member States and the
p.(None): To be communicated to the European Commission and by means of electronic means of communication and, if necessary
p.(None): to make other means available to the public.
p.(None): Monitoring of testing, monitoring and certification bodies;
p.(None): Monitoring the notified bodies
p.(None): Section 69. (1) Surveillance in accordance with Section 68 is also subject to those bodies, institutions or persons who
p.(None): Carry out testing, monitoring and certification activities in accordance with this federal law.
p.(None): (2) Insofar as the bodies or institutions in accordance with paragraph 1 are accredited bodies within the meaning of
...
Orphaned Trigger Words
p.(None): StF: BGBl. No. 657/1996 (NR: GP XX RV 313 AB 389 p. 43. BR: AB 5286 p. 618.)
p.(None): [CELEX No .: 390L0385, 393L0068, 393L0042]
p.(None): modification
p.(None): BGBl. I No. 30/1998 (NR: GP XX RV 915 AB 1037 p. 104. BR: AB 5611 p. 634.)
p.(None): BGBl. I No. 117/1999 (NR: GP XX RV 1778 AB 1983 p. 174. BR: AB 5984 p. 656.)
p.(None): [CELEX No .: 398L0079]
p.(None): BGBl. I No. 98/2001 (NR: GP XXI RV 621 AB 704 p. 75. BR: 6398 AB 6424 p. 679.)
p.(None): BGBl. I No. 33/2002 (NR: GP XXI RV 777 AB 934 p. 89. BR: 6541 AB 6566 p. 683.)
p.(None): [CELEX No .: 398L0027]
p.(None): BGBl. I No. 119/2003 (NR: GP XXII RV 236 AB 289 p. 37. BR: 6888 AB 6904 p. 703.)
p.(None): [CELEX-No .: 32000L0070, 32001L0104]
p.(None): BGBl. I No. 107/2005 (NR: GP XXII RV 675 AB 720 p. 90. BR: AB 7180 p. 717.)
p.(None): BGBl. I No. 153/2005 (NR: GP XXII RV 1092 AB 1142 p. 125.)
p.(None): [CELEX-No .: 32004L0024, 32004L0027, 32004L0028]
p.(None): BGBl. I No. 77/2008 (NR: GP XXIII RV 504 AB 531 p. 59. BR: AB 7943 p. 756.)
p.(None): BGBl. I No. 143/2009 (NR: GP XXIV RV 466 AB 549 p. 49. BR: AB 8236 p. 780.)
p.(None): [CELEX-No .: 32007L0047, 32009L0120]
p.(None): BGBl. I No. 32/2014 (NR: GP XXV RV 33 AB 77 S. 17. BR: AB 9151 S. 828.)
p.(None): [CELEX-No: 31989L0105, 32009L0050, 32011L0024, 32011L0051, 32011L0095, 32011L0098, 32012L0052,
p.(None): 32013L0025]
p.(None): BGBl. I No. 37/2018 (NR: GP XXVI RV 108 AB 139 P. 23. BR: 9967 AB 9970 P. 880.)
p.(None): [CELEX-No .: 32017L2399, 32017L1572]
p.(None): BGBl. I No. 59/2018 (NR: GP XXVI RV 191 AB 231 S. 36. BR: 10001 AB 10017 S. 883.)
p.(None): BGBl. I No. 100/2018 (NR: GP XXVI RV 329 AB 413 p. 57. BR: 10079 AB 10082 p. 888.)
p.(None): text
p.(None): Article II
p.(None): (Note: amendment of the Measurement and Verification Act, Federal Law Gazette No. 152/1950)
p.(None): Article III
p.(None): (Note: Amendment to the Radiation Protection Act, Federal Law Gazette No. 227/1969)
p.(None): Article IV
p.(None): (Note: Amendment of the Medicinal Products Act, Federal Law Gazette No. 185/1983)
p.(None): I. MAIN PIECE
p.(None): Section 1
p.(None): scope of application
p.(None): § 1. This federal law regulates the functionality, performance, safety and quality
p.(None): Manufacturing, placing on the market, distribution, construction, commissioning, maintenance, the
p.(None): Operation, application, clinical evaluation and testing, monitoring and sterilization,
p.(None): Disinfection and cleaning of medical devices and their accessories as well as defense against risks and that
p.(None): Quality management when handling medical devices and their accessories.
p.(None): Section 2
p.(None): definitions
p.(None): General definitions
p.(None): § 2. (1) Medical Devices “are all instruments used individually or in combination,
p.(None): Apparatus, devices, software, materials or other objects, including those from the manufacturer
p.(None): Specifically designed for use in diagnostic or therapeutic purposes and for a flawless
p.(None): Function of the medical device software used by the manufacturer for application to people
p.(None): are intended for the following purposes:
p.(None): 1. detection, prevention, monitoring, treatment or relief of diseases,
p.(None): 2. Detect, monitor, treat, alleviate or compensate for injury or
p.(None): disabilities,
p.(None): 3. Examination, change or to replace the anatomical structure or physiological
p.(None): Operations or
p.(None): 4. Conception regulation
p.(None): and their intended main effect in or on the human body neither through
p.(None): pharmacological or immunological agents are still metabolically achieved, but their mode of action
p.(None): can be supported by such means. The new one is a reprocessed medical device
p.(None): equal.
...
p.(None): if they are used under the intended conditions and for the intended purposes.
p.(None): Any risks and side effects that may result from proper installation, implantation or
p.(None): Application may need to be considered taking into account the effectiveness of the medical devices
p.(None): be defensible to the state of the medical sciences and technology and the protection of health
p.(None): and security must be guaranteed.
p.(None): (2) Medical devices must be designed, manufactured and packaged in such a way that they are suitable for use by
p.(None): Manufacturer to provide specified medical services in accordance with § 2 paragraph 1 or 5 if they
p.(None): Are exposed to loads under normal conditions of use and under those of the manufacturer
p.(None): provided transportation and storage conditions may occur.
p.(None): (3) The design and construction of medical devices must take into account the
p.(None): generally recognized state of science and technology according to the principles of integrated
p.(None): Straighten security. When choosing the most appropriate solutions for design and construction are in the
p.(None): apply the following principles in the order specified:
p.(None): 1. Elimination or minimization of risks by integrating the security concept into the
p.(None): Development and construction of the medical device,
p.(None): 2. If necessary, taking appropriate protective and alarm devices against constructively not
p.(None): eliminating risks,
p.(None): 3. Educate users about the residual risks for which there are no adequate safeguards
p.(None): can be hit.
p.(None): (4) Medical devices in accordance with Section 4a (1) must also include the relevant basic health
p.(None): and meet the safety requirements of Directive 89/686 / EEC.
p.(None): (5) If there is a relevant risk in the case of medical devices within the meaning of Section 4a (2),
p.(None): these also meet the basic health and safety requirements in accordance with Annex I of the Directive
p.(None): 2006/42 / EG, provided these meet basic health and safety requirements
p.(None): are more speci fi c than the basic requirements according to the respective Annex I of the guidelines
p.(None): 90/385 / EEC or 93/42 / EEC.
p.(None): § 9. (1) Every medical device must be provided with information that takes into account the
p.(None): Training and knowledge of the intended user group for the safe use of the
p.(None): Medical device are required. This information must include information in the labeling and
p.(None): in accordance with paragraph 3 exist in the instructions for use.
p.(None): (2) The information required for safe use must be on the medical device itself,
p.(None): be indicated on the unit pack and, if applicable, on the retail pack. If one
p.(None): Individual packaging is not possible, the information must appear on accompanying information. The
p.(None): Federal Minister of Labor, Health and Social Affairs can in accordance with § 10 in accordance with the regulation
p.(None): Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC with regard to the practicability and adequacy of the
p.(None): Attach or provide this information and to ensure safe use
p.(None): provide exceptions for medical devices.
p.(None): (3) Each medical device must be accompanied by instructions for use in its packaging. A
p.(None): Instructions for use are for class I and class IIa medical devices within the meaning of the directive
p.(None): 93/42 / EEC or for in vitro diagnostics within the meaning of Directive 98/79 / EC in duly justified cases
p.(None): then dispensable if the proper and safe use of the medical device without
p.(None): Instructions for use is guaranteed.
...
p.(None): monitoring, testing or other measures in accordance with paragraph 2 if the CE
p.(None): Labeling was wrongly applied or is missing in violation of this federal law.
p.(None): § 23. (1) The Federal Office for Safety in Healthcare determines that the CE marking
p.(None): was improperly attached or is missing in violation of this federal law or evidence in accordance with
p.(None): 15 para. 2 have not been taught within a reasonable period of time, so is the manufacturer or his
p.(None): Authorized representative, without prejudice to Section 77, is obliged to commit the further violation under the conditions of the Federal Office for
p.(None): Preventing healthcare safety from conditions stipulated.
p.(None): (2) If the conditions in accordance with paragraph 1 are not met, the Federal Office for Security in
p.(None): Healthcare in accordance with the procedure of Section 77 to take all appropriate measures to
p.(None): Restrict, prohibit or ensure that the product concerned is placed on the market,
p.(None): that it will be taken off the market. The manufacturer or his authorized representative have these measures
p.(None): to follow immediately.
p.(None): § 24. Is a medical device that does not comply with this federal law or is another
p.(None): Unlawfully provided the product with the CE marking in accordance with this federal law
p.(None): Federal Minister of Labor, Health and Social Affairs vis-à-vis those who have the CE marking
p.(None): has applied, without prejudice to Section 77, the measures required to produce the correct
p.(None): Condition and to take into account the provisions of Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC
p.(None): Initiate proceedings.
p.(None): Section 4
p.(None): Classification and conformity assessment
p.(None): Classification of medical devices
p.(None): § 25. The Federal Minister of Health and Consumer Protection has ordinance with regard to
p.(None): the intended purpose, the technology used and the location, type and duration of the
p.(None): Medical devices taking into account the relevant legal acts of the European Communities
p.(None): 1. Specify those classes that medical devices in particular with regard to
p.(None): Conformity assessment can be assigned, and
p.(None): 2. to define the criteria and rules according to which medical devices are to be assigned to the classes according to Z 1
p.(None): are.
p.(None): § 26. Exists between a manufacturer and a notified body within its scope
p.(None): Federal law as part of a conformity assessment procedure with regard to the classification of a
p.(None): Medical device based on the classification rules according to a regulation according to § 25 none
p.(None): Agreement, so the notified body has the decision of the Federal Office for Security in the
p.(None): To apply for healthcare.
p.(None): European delimitation, classification and derogation clause
p.(None): Section 26a. If the Federal Minister of Health has referred to the Advisory Board in accordance with Section 5b of the Statement,
p.(None): that in accordance with technical progress and the information available on the basis of § 70
p.(None): Adjustment of the classification rules in accordance with Annex IX of Directive 93/42 / EEC is required, he can
p.(None): Submit a sufficiently reasoned application to the European Commission and request that the
p.(None): to take necessary measures to adapt the classification rules.
p.(None): § 26b. The Federal Minister of Health has given the European Commission sufficient
p.(None): submit a reasoned request and ask them to take the necessary action if it is after
p.(None): Referral to the Advisory Board in accordance with Section 5b believes that
p.(None): 1. the application of the classification rules in accordance with Annex IX to Directive 93/42 / EEC
p.(None): Decision on the classification of a specific medical device or a specific one
p.(None): Medical device category required, or
p.(None): 2. a specific medical device or a specific series deviating from the provisions in
p.(None): Annex IX to Directive 93/42 / EEC is to be classified in another class, or
p.(None): 3. the conformity of a medical device or a series deviating from Article 11 of the
p.(None): Directive 93/42 / EEC or in derogation from Article 9 of Directive 90/385 / EEC in exclusive
p.(None): Application of a specific procedure to be determined, which results from the Article 11 of the
p.(None): Directive 93/42 / EEC or from the procedures provided for in Article 9 of Directive 90/385 / EEC
p.(None): is to be selected, or
p.(None): 4. A decision is required as to whether a particular product or a particular one
p.(None): Product group under one of the basic terms in Article 1 Paragraph 2 lit. a to e of
p.(None): Directive 93/42 / EEC or under one of the basic provisions in Article 1 paragraph 2 lit. a, c, d or e
p.(None): Directive 90/385 / EEC, or
p.(None): 5. The list of products listed in Annex II to Directive 98/79 / EC is changed or expanded
p.(None): should, or
p.(None): 6. the conformity of a product or a product group deviating from the provisions of
p.(None): Article 9 of Directive 98/79 / EC using one or more alternative procedures
p.(None): should be determined from the procedures provided for in Article 9 of Directive 98/79 / EC
p.(None): were selected.
p.(None): conformity assessment
p.(None): § 27. Medical devices may only be placed on the market or put into operation if their
p.(None): Conformity with the provisions of this federal law in accordance with a regulation according to § 28
p.(None): was evaluated.
p.(None): § 28. (1) The Federal Minister of Health and Consumer Protection has considered the
p.(None): Relevant legal acts of the European Communities by regulation more detailed regulations on the
p.(None): Make conformity assessment of medical devices.
p.(None): (2) This Ordinance shall specify in particular:
p.(None): 1. Type, design and implementation of the conformity assessment procedures including the respective
p.(None): Declarations of conformity to be issued and the conditions for affixing the CE
p.(None): Labelling,
p.(None): 2. the assignment of the conformity assessment procedures to the individual classes of medical devices,
p.(None): 3. Which conformity assessment procedures by a notified body and which by the manufacturer
p.(None): are to be carried out
p.(None): 4. those conformity assessment procedures which may be initiated by the authorized representative
p.(None): can be
p.(None): 5. the storage and availability of documents related to
p.(None): Conformity assessment procedures,
p.(None): 6. the more detailed conditions under which an exemption according to § 32 is granted
p.(None): can, as well as Art. Content, implementation and handling of the relevant applications,
p.(None): 7. Art. Content and requirements of the declarations to be issued for custom-made products and Art
p.(None): and content of the documentation to be made available for the responsible authorities,
p.(None): 8. Art. Content, availability and transmission of records of custom-made products that are in
p.(None): Placed on the market or put into operation,
p.(None): 9. Which conformity assessment procedures may have to be carried out if medical devices
p.(None): are manufactured or put into operation in healthcare facilities.
p.(None): (3) The Federal Minister of Health and Consumer Protection may, in an ordinance pursuant to para. 1,
...
p.(None): Sterilization provided before their use, sterilized for first placing on the market, must be one
p.(None): apply the procedures referred to in Annexes II or V to Directive 93/42 / EEC. The application of this
p.(None): Appendices and the involvement of the notified body are relevant to the aspects of the sterilization process
p.(None): Achievement of sterility of the medical device limited to opening or damage to the packaging.
p.(None): The person or company must have a statement ready stating that the sterilization
p.(None): according to the manufacturer's instructions.
p.(None): Section 35. (1) Medical devices within the meaning of Section 33 (1) and Section 34 may not be accompanied by an additional CE
p.(None): Labeling. You must provide information in accordance with section 9 and a regulation in accordance with section 10
p.(None): may be attached, which may also be those of the manufacturers of the composite medical devices
p.(None): included instructions included.
p.(None): (2) The explanations for the medical devices listed in paragraph 1 are for monitoring by the
p.(None): Federal Office for Safety in Health Care and the experts commissioned by it for five years
p.(None): long available.
p.(None): Section 6
p.(None): Notified bodies
p.(None): designation
p.(None): Section 36. (1) The conformity assessment procedures in accordance with an ordinance pursuant to Section 28, those designated by
p.(None): Positions must only be carried out by bodies that are European
p.(None): Commission and the other parties to the Agreement on the European Economic Area
p.(None): for which have been named and which are listed in the Official Journal of the European Communities in the Directory of
p.(None): notified bodies, stating their identification number and the tasks for which they have been designated
p.(None): are.
p.(None): (2) The Federal Minister of Health and Consumer Protection can apply relevant domestic
p.(None): Certi fi cation bodies with the appropriate expertise at their request for the implementation of certain
p.(None): Tasks in connection with the procedures according to § 28 for certain medical devices or
p.(None): Name medical device groups if they are approved by the Federal Minister for Economic Affairs for
p.(None): the implementation of these tasks as a certification body and as a testing or inspection body in accordance with
p.(None): the Accreditation Act, Federal Law Gazette № 468/1992, are accredited, whereby it must be taken into account that the
p.(None): Criteria of § 37 are met.
p.(None): (3) From the bodies that meet the criteria set out in the relevant harmonized standards
p.(None): correspond, it is assumed that they meet the minimum criteria set out in paragraph 2.
p.(None): (4) The Federal Minister of Health and Consumer Protection has the appointment of a position
p.(None): revoke it if it determines that the position no longer meets the criteria of paragraph 2, or restrict it,
p.(None): if he determines that they meet the requirements of paragraph 2 with regard to certain tasks, procedures
p.(None): or medical devices or product groups no longer met.
p.(None): (5) The Federal Minister of Health and Consumer Protection has the other contracting parties of the
p.(None): Agreement on the European Economic Area and the European Commission on designations
p.(None): in accordance with paragraph 2 and about the revocation or the restriction of a designation in accordance with paragraph 4 in
p.(None): To put knowledge.
p.(None): Minimum criteria for notified bodies
p.(None): Section 37. (1) The notified body, its manager and that by carrying out the assessments and tests
p.(None): Commissioned personnel must be independent of the body responsible for the medical device to be assessed
p.(None): has developed or constructed, as well as by its manufacturer, distributor, installer or user. they may
p.(None): neither directly nor as an agent for the development or construction, the manufacture, the sales
p.(None): or be involved in the maintenance of these products for the applicant. The possibility of one
p.(None): This does not result in the exchange of technical information between the manufacturer and the notified body
p.(None): locked out.
p.(None): (2) The notified body must be capable of all in accordance with a conformity assessment procedure
p.(None): a regulation provided for in § 28 tasks which are assigned to such a position and for which
p.(None): it is designated to perceive, be it that these tasks are performed by the notified body itself or be it that it
p.(None): are carried out in some areas under their responsibility. You must in particular about the staff
...
p.(None): if applicable, relevant harmonized standards have to be taken into account according to a de fi ned and
p.(None): methodically flawless procedures based on a critical assessment
p.(None): 1. the available relevant scientific literature on safety, performance,
p.(None): Design features and purpose of the medical device, whereby
p.(None): a) the similarity of the medical device with the medical device to which the
p.(None): Get data, and
p.(None): b) the data is reasonably consistent with the relevant fundamental
p.(None): Have to prove requirements, or
p.(None): 2. the results of all clinical trials carried out, or
p.(None): 3. Combined clinical data according to Z 1 and 2.
p.(None): (3) For active implantable medical devices and for implantable medical devices and
p.(None): Class III medical devices of Directive 93/42 / EEC are to be subjected to clinical trials, if
p.(None): because the use of existing clinical data is sufficiently proven.
p.(None): (4) The clinical evaluation and its result must be documented. This documentation or a
p.(None): A detailed reference to this must be included in the technical documentation for the medical device.
p.(None): (5) The clinical evaluation and its documentation must be active on the basis of the monitoring
p.(None): data received after placing on the market are kept up to date. Becomes a clinical
p.(None): Post-market surveillance as part of the post-marketing surveillance plan
p.(None): Placing on the market is not considered necessary, this must be justified and documented.
p.(None): (6) If the manufacturer or his authorized representative deem it unnecessary to provide proof of
p.(None): Compliance with the essential requirements based on clinical data in the sense of
p.(None): To lead paragraph 1, such an exception is to be justified accordingly. This justification has on the
p.(None): Result of risk management and has the peculiarities of the interaction between
p.(None): Body and medical device, the intended clinical performance and the information provided by the manufacturer
p.(None): consider. The suitability of evidence of compliance with the essential requirements
p.(None): Justification of performance, product tests and preclinical evaluation alone must be justified.
p.(None): (7) Evidence that those listed in Annex I, Chapter A, Section 3 of Directive 98/79 / EC
p.(None): performance-related requirements of an in vitro diagnostic medical device under normal operating conditions
p.(None): as well as the assessment of risks and the acceptability of the benefit / risk ratio to which
p.(None): Annex I, Chapter A, Section 1 of Directive 98/79 / EC, must always refer to
p.(None): based on performance data.
p.(None): (8) The evaluation of the performance data in accordance with paragraph 7, hereinafter referred to as "performance evaluation",
p.(None): where, where appropriate, the common technical speci fi cations and relevant harmonized
p.(None): Standards have to be taken into account according to a defined and methodically perfect procedure
p.(None): are based on a critical assessment
p.(None): 1. the available relevant scientific literature on safety, performance,
p.(None): Design features and purpose of the in vitro diagnostic medical device, whereby
p.(None): a) the similarity of the in vitro diagnostic with the in vitro diagnostic has to be demonstrated
p.(None): that the performance data refer, and
p.(None): b) the performance data reasonably in accordance with the relevant
p.(None): have to prove basic requirements, or
p.(None): 2. the results of all performance assessment tests carried out, or
p.(None): 3. of published or unpublished reports on other clinical experience with the
p.(None): concern in-vitro diagnostic or a similar in-vitro diagnostic, the similarity
p.(None): can be demonstrated with the relevant in vitro diagnostic medical device, or
p.(None): 4. of combined performance data according to Z 1 to 3.
p.(None): (9) The performance evaluation and its result are to be documented. This documentation or a
p.(None): Detailed references to this are in the technical documentation on the in vitro diagnostic medical device
p.(None): take. The performance evaluation and its documentation must be based actively on the from the
p.(None): Monitoring performance data obtained after placing on the market kept up to date
p.(None): become.
p.(None): Section 2
p.(None): Clinical trial
p.(None): Purpose of the clinical trial
...
p.(None): performed in vitro diagnostic or therapeutic consequences for the
p.(None): Exam participants may have, §§ 47 to 54 do not apply to the performance assessment examination of in-
p.(None): vitro diagnostics.
p.(None): statutory authorization
p.(None): § 66. The Federal Minister of Labor, Health and Social Affairs has, provided this with regard to the
p.(None): clinical evaluation, the proper planning, implementation, evaluation and control of clinical
p.(None): Tests or performance assessments of in vitro diagnostic medical devices with a view to protecting the
p.(None): Health and safety of test subjects and ensuring scientific
p.(None): Significance of clinical trials or performance assessment tests appears to be required by regulation
p.(None): taking into account the relevant legal acts of the European Communities
p.(None): Regarding provisions
p.(None): 1. The requirements for the clinical evaluation of medical devices, their documentation and their
p.(None): Implementation, especially in the context of conformity assessment,
p.(None): 2. those types, groups or classes of medical devices, in any case during their clinical evaluation
p.(None): clinical data are to be used,
p.(None): 3. Further requirements for the planning, implementation and evaluation of clinical
p.(None): Tests of medical devices or the performance evaluation test of in vitro diagnostics,
p.(None): 4. The tasks and areas of responsibility as well as the quali fi cation of the implementation of the clinical
p.(None): Examination or people involved in the performance evaluation test,
p.(None): 5. Art. Content, scope and design of the for the conduct of the clinical trial or
p.(None): Performance assessment test required documents, in particular the test plan, the
p.(None): Evaluation plan, the manual of the clinical investigator, the final report, the documents
p.(None): for the clarification and obtaining consent, as well as about statistical planning, analysis
p.(None): and evaluation and storage of data and documents,
p.(None): 6. quality management in the context of the clinical trial or the performance assessment test,
p.(None): 7. Art. Content, scope and implementation of the notification, declaration and documentation in accordance with § 40,
p.(None): 8. Minimum requirements for insurance in accordance with sections 47 and 48 as well
p.(None): 9. Assumption of conformity with provisions on the clinical trial of medical devices or the
p.(None): Performance assessment testing of in vitro diagnostics with regard to relevant harmonized
p.(None): standardize
p.(None): set.
p.(None): IV. MAIN PIECE
p.(None): Section 1
p.(None): Registration of manufacturers, distributors, test centers and users
p.(None): Section 67. (1) Who is responsible for the initial placing on the market of medical devices in accordance with Section 2
p.(None): Paragraph 12 is, assembles medical devices in the sense of § 33 Paragraph 1 or sterilizes them in the sense of § 34, and
p.(None): has its seat in the area of application of this federal law, taking this into consideration
p.(None): Provisions of an ordinance according to paragraph 7 to the Federal Ministry of Labor, Health and Social Affairs
p.(None): or report to a notified body before starting work. This also applies to the rest
p.(None): Placing medical devices on the market, as far as for them in a regulation according to § 99 distribution channels
p.(None): are prescribed and enrollment in the register of distributors is planned.
p.(None): (2) The notification according to paragraph 1 must at least contain:
p.(None): 1. Name or company name and address of the notifier,
p.(None): 2. the type of activity,
p.(None): 3. the type of medical devices,
p.(None): 4. Further information required for the rapid coordination of measures in accordance with sections 75 and 77
...
p.(None): serious side effects, or
p.(None): 3. previously unknown mutual influences, or
p.(None): 4. serious quality defects,
p.(None): which have become known to you on the basis of your professional activity, immediately to the Federal Office of
p.(None): Healthcare security reporting, as well as all observations and data relevant to that
p.(None): Medical device safety can be important.
p.(None): (2) Reports in accordance with Paragraph 1 are in default at hospitals, except where there is any other danger,
p.(None): to be carried out uniformly by the medical director.
p.(None): (3) All natural or legal persons who place medical devices on the EEA for the first time
p.(None): and those companies, facilities or persons who place medical devices on the market have this
p.(None): Federal Office for Safety in Health Care immediately incidents according to paragraph 1 and above
p.(None): corrective measures, such as
p.(None): 1. Any technical or medical reason associated with a medical device that
p.(None): Systematic recall of medical devices of the same type from the market by the manufacturer
p.(None): has led
p.(None): 2. the issuing of a recommended measure,
p.(None): 3. the additional monitoring or modification of products,
p.(None): 4. Modifications to the product design of components or the manufacturing process, and
p.(None): 5. Modifications to the labeling or the instructions for use
p.(None): tell.
p.(None): (4) The Federal Office for Safety in Health Care has to take the necessary measures
p.(None): thus the person responsible for the first placing on the market in the EEA also of an incident
p.(None): is taught in accordance with paragraph 1.
p.(None): (5) To the extent that it ensures the uniformity and the information content of the reports
p.(None): is required, the Federal Minister of Health and Consumer Protection has considered the
p.(None): Requirements for in-depth and quick information by regulation, more detailed provisions on content,
p.(None): Scope, form and transmission of the messages as well as the data carriers to be used and
p.(None): To establish communication channels.
p.(None): (6) All natural or legal persons who place medical devices on the EEA for the first time
p.(None): and those companies, facilities or persons who place medical devices on the market are obliged to
p.(None): their reporting and information obligations in connection with incidents in accordance with paragraphs 1 and
p.(None): Measures according to paragraph 3 towards the contracting parties of the EEA in accordance with the guidelines
p.(None): 90/385 / EEC, 93/42 / EEC and 98/79 / EC immediately and verifiably to comply.
p.(None): (7) After the Federal Office for Safety in Health Care an incident according to paragraph 1 and
p.(None): Measures in accordance with paragraph 3, if possible together with the manufacturer or his authorized representative,
p.(None): has assessed the European Commission and the other Member States immediately via the
p.(None): to teach measures taken. This excludes information about the underlying
p.(None): Incidents.
p.(None): Registration and evaluation of reports; investigations
p.(None): Section 71. The Federal Office for Safety in Health Care has knowledge of it according to Section 70
p.(None): to record, assess and, if necessary, the information provided under this Act
p.(None): to determine, coordinate and monitor the measures to be taken. The responsibilities and
p.(None): Obligations of those responsible for placing on the market as well as professional or professional users
p.(None): and operators according to § 72 are not affected.
p.(None): Section 72. (1) The users and operators of medical devices in healthcare facilities
p.(None): as well as those responsible for placing medical devices on the market, especially in the
p.(None): Connection with the evaluation of reports according to § 70 or a justified suspicion according to
p.(None): Section 75, which became known to them in the course of their professional or commercial activity, obliges
p.(None): 1. Take all necessary measures and precautions in your own area to avoid possible risks
p.(None): and identify risks to the health and safety of patients, users or third parties
p.(None): and evaluate
p.(None): 2. All necessary precautions and measures, especially with regard to the transfer of
p.(None): Information about dangers posed by medical devices to protect health and safety
p.(None): Ensure the safety of patients, users or third parties, and
p.(None): 3. to support investigations by the competent authorities with all available means and
p.(None): if necessary, to carry out or arrange for own examinations of medical devices
p.(None): and to make their results immediately available to the competent authorities.
p.(None): (2) Within the scope of the obligations according to paragraph 1 are in particular also
p.(None): 1. Medical devices and their instructions for use or accompanying information and, insofar as this is for the
p.(None): Evaluation is important, also combinations with accessories, with other medical devices, with
p.(None): Make medicinal products or other products accessible for examinations,
p.(None): 2. If applicable, documents and other information, as well as certi fi cates and other information
p.(None): through the conformity assessment procedures carried out to make an assessment
p.(None): enable to what extent the medical device and its manufacture meet the requirements of this
p.(None): Comply with federal law,
p.(None): 3. If necessary, comparisons with similar or similar medical devices from our own
p.(None): Area to allow
p.(None): 4. Information on the exact identification of the affected medical devices or combinations according to Z 1
p.(None): to give
p.(None): 5. Submit data regarding the traceability of medical devices according to § 73 and
p.(None): 6. if necessary, all for the clarification and evaluation of the specific conditions of the installation,
p.(None): Erection, maintenance and application of the affected medical devices necessary information
p.(None): and to provide information.
p.(None): Section 72a. (1) Is there a reasonable suspicion that a patient is suffering from a defective medical device?
p.(None): Has suffered health damage or has been killed, is the establishment of health care
...
p.(None): is required considering types, groups or classes of medical devices with increased
p.(None): Risk potential through regulation for those responsible for placing medical devices on the market and
p.(None): Health care institutions for appropriate preventive measures and measures with regard to the
p.(None): Commit to traceability of medical devices while making determinations about
p.(None): 1. The types, groups or classes of medical devices that depend on the requirements of the
p.(None): Traceability are captured
p.(None): 2. the product- or product group-specific requirements regarding traceability as well
p.(None): with regard to the type, content, specificity and availability of the necessary records,
p.(None): and
p.(None): 3. the way of setting up suitable implant registers in facilities of the
p.(None): Healthcare and the necessary records.
p.(None): observational
p.(None): Section 74. The Federal Minister of Health and Consumer Protection may consider
p.(None): serious interests of public health and with a view to gaining improved
p.(None): Knowledge about the benefit / risk assessment of certain types or groups of medical devices,
p.(None): in particular also about the long-term effects of implantable medical devices that can only be
p.(None): systematic data collection and evaluation can be obtained, prescribe by regulation,
p.(None): that relevant data that has been collected in connection with the use of these medical devices and
p.(None): for the acquisition of these findings are necessary for a central evaluation
p.(None): are put. The personal reference is part of the central collection and evaluation of such data
p.(None): by pseudonymization.
p.(None): Section 5
p.(None): Protection against risks
p.(None): Section 75. If there is reasonable suspicion that
p.(None): 1. A medical device also contributes to the health or safety of patients, users or third parties
p.(None): proper implantation, erection, maintenance or according to its purpose
p.(None): Use beyond a reasonable level based on medical science
p.(None): can endanger, or
p.(None): 2. a medical device meets the basic requirements in terms of §§ 8, 9, a regulation
p.(None): § 10 or, if applicable, does not meet the requirements of § 11, or
p.(None): 3. a medical device has other defects that pose an unacceptable risk to patients,
p.(None): Can lead users or third parties, or
p.(None): 4. Defects in the development, manufacture or final inspection of a medical device
p.(None): have occurred or are occurring that pose an unacceptable risk to patients or users
p.(None): or lead third parties
p.(None): the Federal Office for Safety in Health Care has to make the necessary assessments,
p.(None): Monitor measures in accordance with § 72, carry out or arrange for necessary examinations
p.(None): or the person or device that places the medical device on the market, uses it, puts it into operation or
p.(None): operates to arrange for the medical device to be operated by a notified body, another appropriate body
p.(None): accredited body or to be examined by an expert and give him the reports and results
p.(None): required. The positions or experts are in agreement with the Federal Office for Security in the
p.(None): Select healthcare.
p.(None): Section 76. (1) In the context of the assessment of reports in accordance with Section 70 (1), the assessment
p.(None): especially to extend to the question
p.(None): 1. what caused the event,
p.(None): 2. whether the medical device was in an improper condition,
p.(None): 3. whether there is no longer any danger after the defect has been remedied, and
p.(None): 4. whether new knowledge has been gained, the other or additional precautions,
p.(None): especially with regard to similar medical devices.
p.(None): (2) Cash expenses that the Federal Office for Safety in Health Care in connection with a
p.(None): Assessments in accordance with Section 75 and Paragraph 1 have to be made by the person responsible for placing on the market
p.(None): wear, if on the basis of such an assessment a measure in the sense of § 77 due to a lack of
p.(None): a medical device or its labeling or instructions for use.
p.(None): Section 77. (1) The Federal Office for Safety in Health Care determines that medical devices
p.(None): 1. Can endanger the health or safety of patients, users or third parties, too
p.(None): if they are properly installed, commissioned, maintained and their intended purpose
p.(None): be used accordingly, or
...
p.(None): outside healthcare facilities
p.(None): General requirements
p.(None): Section 80. (1) Healthcare facilities must ensure that
p.(None): 1. Medical devices only according to their intended purpose, according to the regulations of this
p.(None): Federal law or the regulations issued on the basis thereof, the generally recognized
p.(None): Established, operated rules of technology as well as occupational safety and accident prevention regulations,
p.(None): applied and maintained,
p.(None): 2. Medical devices for common use with other medical devices, with accessories, with
p.(None): Software or with other objects only if this connection in the
p.(None): Is harmless with regard to medical safety and functionality,
p.(None): 3. Medical devices are only used by people who, due to their training, their
p.(None): other knowledge or based on their practical experience and, if necessary, one
p.(None): product- or product group-specific instruction the guarantee for a proper
p.(None): Provide handling; the instructions for use and the other enclosed
p.(None): to observe safety-related information of the products involved,
p.(None): 4. before each use of a medical device, the users check the functionality,
p.(None): Operational safety and the proper condition of the medical device convince, so far
p.(None): such a review is reasonably expected according to the circumstances of the specific application
p.(None): can be; this also applies accordingly to those common to the medical device
p.(None): Application related other medical devices, accessories, software and other items,
p.(None): 5. Only medical devices installed, kept ready, put into operation and used in their area
p.(None): be, their compliance with the requirements according to this by this federal law
p.(None): the intended procedure was determined.
p.(None): (2) The Federal Minister of Health and Consumer Protection has for certain species, groups or
p.(None): Classes of medical devices by ordinance that go beyond the requirements of paragraph 1
p.(None): Requirements with regard to the construction, operation, use and maintenance of medical devices
p.(None): in healthcare facilities to the extent that this is to avert special dangers for
p.(None): Patients, users or third parties is required and insofar as it is not already based on commercial law
p.(None): Regulations special requirements are set for this.
p.(None): Commissioning, application
p.(None): Section 81. (1) The Federal Minister of Health and Consumer Protection has, provided this with regard to the
p.(None): safe use of medical devices in healthcare facilities or defense
p.(None): application or other medical device-related hazards is required, by regulation types,
p.(None): Designate classes or groups of medical devices for their safe operation and safe
p.(None): Application special safety precautions are to be taken, and minimum requirements for type and
p.(None): Specify the scope of these security measures. Provided by such a regulation
p.(None): Regulations regarding the use of medical devices by traders are provided
p.(None): the Federal Minister of Health and Consumer Protection in agreement with the Federal Ministry
p.(None): to deal with economic matters.
p.(None): (2) The institution or person responsible for the implantation of a medical device has the
p.(None): Patients who are being implanted with a medical device or, if applicable, their legal representative
p.(None): To provide information including all for the identification of the implanted medical device
p.(None): of the accessories as well as the safety for the patient after the implantation
p.(None): necessary information and instructions on behavior are included, including information about
p.(None): when the patient see a doctor and what environmental influences he or she does not or only under
p.(None): Should take appropriate precautions. The relevant information in the
p.(None): Instructions for use and the other safety information attached to the
p.(None): implantable medical devices must be observed.
p.(None): (3) The Federal Minister of Health and Consumer Protection, if this is considered
p.(None): the protection of health and safety and the rights of patients and with regard to
p.(None): Uniformity and practicability appear necessary in a regulation according to § 92 more detailed provisions
p.(None): about art. content, scope, issuance and accessibility of information according to paragraph 2 and other for
p.(None): Patients of certain personal data related to the use of
p.(None): Medical devices.
p.(None): (4) When informing patients about the use of medical devices
p.(None): to pay attention to the corresponding instructions in the instructions for use.
p.(None): Information for users
p.(None): Section 82. Instructions for use and safety-related information attached to the medical device
p.(None): for medical devices within the meaning of Section 81 (1) are to be kept in such a way that they comply with the
p.(None): Application people are accessible at all times.
p.(None): Instruction of the staff
p.(None): Section 83. (1) Medical devices in accordance with an ordinance pursuant to Section 81 (1) may only be used by persons
p.(None): applied to the medical device or to a medical device of this type
p.(None): Consideration of the instructions for use and the attached safety-related information in the
p.(None): Appropriate handling instructed and also on special application and
p.(None): medical device-specific dangers have been pointed out. Only persons who are allowed to instruct
p.(None): who, on the basis of their training, knowledge and practical experience, have been instructed in the
p.(None): Handling these medical devices are suitable. If necessary, the operator has recurring
p.(None): To provide training.
p.(None): (2) Are medical devices in accordance with a regulation pursuant to Section 81 (1) with accessories, software or
p.(None): The training of the personnel has expanded to other medical devices into device combinations
p.(None): respective combinations and their special features.
...
p.(None): Results must be documented and listed in the device directory. In the device directory are
p.(None): to keep the intervals of recurring examinations and briefings according to § 83 evident.
p.(None): Suitability for exams
p.(None): Section 90. (1) Only persons are allowed to carry out examinations in accordance with Sections 86 to 88
p.(None): be used, the
p.(None): 1. on the basis of their professional training and practical experience in the examination of
p.(None): Medical device experience and knowledge, especially with regard to
p.(None): the relevant provisions and standards on the required expertise,
p.(None): 2. about the necessary measuring and testing equipment,
p.(None): 3. about the required reliability and
p.(None): 4. In particular with regard to the cases of Sections 87 and 88 on the required organizational
p.(None): Requirements for the planning, execution and evaluation of the exams
p.(None): dispose of and are able to conduct the examinations in accordance with Sections 86 to 88 in accordance with their type and scope
p.(None): and to be carried out comprehensibly. Other than the test, monitoring or
p.(None): Certi fi cation bodies are suitable for the examinations if they are about persons within the meaning of Z 1 to 4
p.(None): feature.
p.(None): (2) Relevant as testing or monitoring bodies for products for the relevant
p.(None): In any case, bodies accredited by the medical device sector are considered to be suitable bodies within the meaning of paragraph 1.
p.(None): Avoiding hazards
p.(None): § 91. If, in the course of measures to maintain a medical device, hazards for
p.(None): Suitable measures to take to prevent patients, users or third parties from occurring
p.(None): To avert danger to people.
p.(None): statutory authorization
p.(None): Section 92. (1) The Federal Minister of Health and Consumer Protection has to guarantee and
p.(None): Maintenance of the medical performance of medical devices according to § 2 paragraph 1 or 5 and
p.(None): to ensure the continuity of their safe use and the prevention of risks in particular
p.(None): taking into account the type of health care establishment by regulation
p.(None): Provisions on the construction, operation, use and maintenance of medical devices
p.(None): or certain types or groups of medical devices, insofar as the electrical safety and the
p.(None): functions of medical devices covered by the measurement and calibration law, in agreement with
p.(None): the Federal Minister for Economic Affairs. He has relevant to it
p.(None): Take harmonized standards into account. If there are no such speci fi c regulations,
p.(None): he can refer to other suitable national or international standards.
p.(None): (2) In a regulation in accordance with paragraph 1 in particular more detailed provisions on
p.(None): 1. any additional requirements required under Section 80 (2),
p.(None): 2. Art. Content, scope, execution and accessibility of records and documentation according to
p.(None): sections 81 to 84 and 89,
p.(None): 3. the instruction of the personnel according to § 83,
p.(None): 4. The requirements for those persons or bodies who take maintenance or maintenance measures
p.(None): Examinations are authorized in accordance with sections 81 and 86 to 88,
p.(None): 5. Measures for proper maintenance,
p.(None): 6. Types, groups or classes of medical devices that undergo regular checks
p.(None): are,
p.(None): 7. Types, groups or classes of medical devices that are subject to a maintenance obligation
p.(None): Section 85 (4) 1 or 2, including any requirements for availability and
p.(None): Use of these medical devices and required training measures as well
p.(None): 8. Type, scope, implementation and intervals of examinations in accordance with sections 86 to 88
p.(None): to enact and designate those medical devices for their safe operation or their safe
p.(None): Special safety precautions must be taken, as well as minimum requirements for their type
p.(None): and scope.
p.(None): (3) The umbrella organization of social insurance institutions is before issuing a regulation in accordance with paragraph 1
p.(None): with regard to medical devices within the meaning of section 85 (4) (1).
p.(None): Section 2
p.(None): Cleaning, disinfection and sterilization of medical devices in or for facilities of the
p.(None): health
p.(None): § 93. (1) Cleaning, disinfection and sterilization of medical devices in or for facilities of the
p.(None): Healthcare systems are without prejudice to Section 34, taking into account the type of medical devices
p.(None): such devices or device systems and suitable validated procedures to carry out and in
p.(None): Organize with regard to the type, size and task of the facility so that the success of this
p.(None): Process is comprehensibly guaranteed and the safety and health of patients and users
p.(None): or not endangered to third parties.
p.(None): (2) Cleaning, disinfection and sterilization of medical devices in or for facilities of the
p.(None): Healthcare in particular have the requirements laid down in a regulation in accordance with § 94
p.(None): correspond to.
p.(None): § 94. The Federal Minister of Health and Consumer Protection, taking into account Art
p.(None): and size of the healthcare facility and taking into account the relevant
p.(None): harmonized standards, other relevant international or national standards with regard to the
p.(None): Ensure the safety and health of patients, users, or third parties is protected
p.(None): Regulation to adopt special provisions regarding the
p.(None): 1. devices or systems to be used, their properties and their maintenance,
p.(None): 2. tools to be used,
p.(None): 3. method to be used,
p.(None): 4. Measures for validation and routine control,
p.(None): 5. Organization of sterilization and disinfection,
p.(None): 6. Quality management measures,
p.(None): 7. regular inspections and
p.(None): 8. Relevant basic, advanced and further training of the staff.
p.(None): Section 3
p.(None): Quality management measures during construction, commissioning, application,
p.(None): Maintenance, disinfection and sterilization of medical devices in facilities of the
p.(None): health
p.(None): § 95. (1) The Federal Minister of Health and Consumer Protection, as far as this with the
p.(None): Erection, commissioning, application, maintenance, disinfection and sterilization of medical devices
p.(None): in healthcare facilities with a view to ensuring and maintaining the
p.(None): medical services of medical devices with regard to their intended purpose according to § 2 paragraph 1
p.(None): or 5, the minimization of possible side effects, compliance with the basic requirements that
p.(None): Ensuring the safety and health of patients, users or third parties or the defense against
p.(None): Risks and is indicated in terms of the type and scope of the facility by
p.(None): Regulation Establish minimum requirements for measures and precautions for quality management.
p.(None): He has to take into account any relevant national and international standards.
p.(None): (2) Insofar as it is necessary with regard to the objective of paragraph 1, the Federal Minister for
p.(None): Health and consumer protection by regulation stipulate those requirements and requirements,
p.(None): among those in health care systems regarding quality management
p.(None): Erection, application, operation, maintenance, disinfection and sterilization of
p.(None): Medical devices or certain types or groups of medical devices within the meaning of this
p.(None): Federal law can be certi fi ed. He has any relevant national and international
p.(None): Standards.
p.(None): (3) The Federal Minister of Health and Consumer Protection can with regard to the flawless
p.(None): Testing, monitoring and certi fi cation of quality management systems with regard to the establishment,
p.(None): Application, operation, maintenance, disinfection and sterilization of medical devices or
p.(None): certain types or groups of medical devices in healthcare facilities and for
p.(None): Ensuring the fulfillment of the requirements according to a regulation according to paragraph 2 requirements and
p.(None): Specify requirements for those bodies that check quality management systems in accordance with paragraphs 1 and 2,
p.(None): monitor or certi fi cate. He has any relevant national and international standards
p.(None): consider.
p.(None): § 96. The Federal Minister of Health and Consumer Protection has, if this with regard to
p.(None): serious public health interests or averting serious risks are required,
p.(None): by regulation the application or operation of certain types or groups of medical devices
p.(None): to restrict healthcare facilities whose quality management systems
p.(None): in this regard demonstrably meet the requirements of an ordinance pursuant to Section 95 (1) or which are stated in
p.(None): Are certified in accordance with an ordinance pursuant to Section 95 (2).
p.(None): minimum standards
...
p.(None): Protect the health and safety of patients, users or third parties and protect them significantly
p.(None): Risks is required through regulation conformity assessment procedures for medical devices for which the
p.(None): Transitional regulation of paragraph 1 applies as a prerequisite for placing on the market and commissioning
p.(None): to prescribe and specify their type. Content and implementation.
p.(None): (4) Clinical trials that started before this Federal Act came into force may continue
p.(None): the regulations in force at the start of the clinical trial.
p.(None): (4a) Performance appraisal examinations that started before June 7, 2000 may be conducted according to the
p.(None): regulations in force at the time the performance assessment test begins.
p.(None): (5) Mercury glass thermometer with maximum device, for which an EEC type approval in accordance
p.(None): in implementation of Directive 75/764 / EEC, OJ. № L 262 of July 27, 1976, issued national
p.(None): Regulations issued until December 31, 1994 may be placed on the market until June 30, 2004 and
p.(None): be put into operation.
p.(None): (6) Medical devices that were installed in facilities of the
p.(None): Healthcare systems in operation or kept ready for use may continue to be operated there
p.(None): or applied, unless they are defective in terms of their safety or performance,
p.(None): which can endanger patients, users or third parties.
p.(None): (7) Companies, facilities or persons within the meaning of Section 67 (1), (3) and (4) which are already in force
p.(None): of this federal law, they are obliged to notify according to § 67 by
p.(None): March 1, 1997.
p.(None): (8) reviews by ethics committees as of the date of entry into force of this
p.(None): Federal law are pending, are to be up to date by the ethics committees in their composition
p.(None): End to lead.
p.(None): (9) Medical devices with derivatives from human blood, which the on January 10, 2002 in Austria in
p.(None): Applicable regulations, may continue until the end of January 10, 2007 in
p.(None): Austria are placed on the market. Medical products with derivatives placed on the market in this way
p.(None): human blood may still be placed on the market in Austria until the end of January 10, 2009
p.(None): or be put into operation, unless the requirements according to §§ 8 and 9 are not met or
p.(None): measures are taken in accordance with § 77. Changes to these regulations are for the purpose
p.(None): the protection of people from direct or indirect health risks
p.(None): apply.
p.(None): § 113. Insofar as this federal law refers to provisions of other federal laws, these are
p.(None): Applicable provisions in their currently applicable version.
p.(None): Come into effect
p.(None): § 114. (1) This federal law occurs one month after its announcement
p.(None): First of the month in force.
p.(None): (2) Section 54 in the version of the Federal Law BGBl. I No. 30/1998 comes into force on January 1, 1998.
p.(None): (3) Section 2 (5) 1 lit. c to g, § 2 paragraphs 5a and 5b, § 2 paragraph 6, § 2 paragraph 8a, § 2 paragraph 10 line 1, § 2 paragraph 11,
p.(None): Section 2 (15), the heading to Section 3, Section 3 (2a), Section 3 (3a), Section 3 (7a), Section 3 (14a), Section 9 (2) and (3), Section 9
p.(None): Section 5, Section 11 Section 4, Section 13 Section 1a, Section 15 Section 1, Section 18 Section 1, Section 19 Section 1, Section 21, Section 27, Section 28 Section 2 Nos 7 to 9, § 29
p.(None): Paragraph 2, Section 29 Paragraph 5, Section 29 Paragraph 7, Section 31, Section 33, Section 34, Section 37 Paragraphs 9 to 11, Section 65a, Section 66, Section 111 Z 2a, Section 111 Z 13a,
p.(None): Section 112 (4a) of this Federal Act, in the version of the Federal Law BGBl. I № 117/1999, also come into play
p.(None): June 7, 2000 in force.
p.(None): (4) Section 2 (2), Section 2 (13), Section 4 (1) 3 to 5, Section 5 (3), Section 12, Section 14, Section 18 (1), Section 23 (2), Section 24, § 67
p.(None): Paragraphs 1 to 3, Section 76 Paragraph 2, Section 77 Paragraph 3, Section 111 Z 19a, Section 112 Paragraphs 1 and 2, Section 113, Section 116a, Section 117 Paragraph 1 Section 2
p.(None): this federal law in the version of the federal law BGBl. I № 117/1999 come into force on December 7th
p.(None): 1999 in force.
p.(None): (5) § 104 and § 111a in the version of the Federal Law BGBl. I № 33/2002 follow one month
...
p.(None): Introductory words of section 15 subsection 2, section 22 subsections 2 and 3, section 23, sections 26a and 26b including the heading, section 28 subsection 2 no.4,
p.(None): Section 29 (1), the introductory words of Section 33 (1), Section 34, Section 36 (2), Section 37 (9) and (12), the heading of
p.(None): Section 1 of III. Main piece, § 38, § 40, §§ 40a and 40b including headings, § 41 paragraph 1, 2, 4 and 6,
p.(None): Section 42 (8), Section 43, Section 44, Section 47 (1), (2) and (3), Section 49, Section 50 (1), 2 and 4, Section 51, Section 52a (3), Section 56 (3) to 7,
p.(None): Section 59 (1), 1a and 3, Section 60 (1) to (3), Section 61, Section 63 (4) to (6), Section 64 (1), 4 and 7, Section 65, Section 65a (1) and
p.(None): 2, section 66, section 67 (7), section 70 (1), (3), (4), (6) and (7), section 77 (1) lines 2a and 3, section 77 (2a), section 111 (5), 13 and 15,
p.(None): § 113, § 116 paragraphs 2 and 3, § 116a No. 7, in the version of the Federal Law BGBl. I № 143/2009 come into play
p.(None): March 21, 2010 in force. Section 68 (11) to (13) in the version of the Federal Law Gazette I No. 143/2009 also comes into effect
p.(None): Effective January 1, 2010.
p.(None): (10) Data protection consent in connection with clinical trials that were carried out before
p.(None): May 25, 2018, do not need to be renewed.
p.(None): (11) Sections 11 (4), 49 (4), 5 and 6, 50 (1), 52a (3) and 5, 55 (1), 59 (3), 64
p.(None): Paragraph 4a, § 73 Paragraph 1, 2, 4, 4a, 5, 6, 8, 11, 12 14, 17, § 73a Paragraph 2, 3, 5, 6, 9, 11 and 12, § 74, Section 89 paras. 1 to 3,
p.(None): Section 110a (1) to (3) and the deletion of Section 73 (9), (10) and (18) and Section 73a (7) in the version of the
p.(None): 2.Materials Data Protection Adjustment Act, Federal Law Gazette I No. 37/2018, enter into force on May 25, 2018.
p.(None): (12) Section 50 subsections 2 and 4 and section 52 of this Federal Act in the version of Federal Law Gazette I No. 59/2018 also come into play
p.(None): July 1, 2018 in force.
p.(None): Section 115. Ordinances based on this federal law can already be made available from the date of its publication
p.(None): the following day. They may enter into force at the earliest with the entry into force of this federal law
p.(None): be set.
p.(None): § 116. (1) With the entry into force of this Federal Act, the Health Protection Act, BGBl.
p.(None): No. 163/1952, no longer applicable.
p.(None): (2) The ordinance regarding dental amalgam, BGBl. № 575/1990, comes into effect at the end of the day of
p.(None): Announcement of this federal law in the version of the federal law BGBl. I № 143/2009 except
p.(None): Force.
p.(None): (3) The Condom Testing Ordinance, Federal Law Gazette № 630/1990, comes into effect at the end of the day of the announcement
p.(None): of this federal law in the version of the federal law BGBl. I No. 143/2009.
p.(None): Reference to guidelines
p.(None): § 116a. This federal law makes the following guidelines of the European Community
p.(None): implemented:
p.(None): 1. Directive 90/385 / EEC relating to active implantable medical devices (OJ № L 189,
p.(None): July 20, 1990);
p.(None): 2. Directive 93/68 / EEC (OJ No L 220 of 30 August 1993);
p.(None): 3. Directive 93/42 / EEC on medical devices (OJ No. L 169 of 12 July 1993);
p.(None): 4. Directive 98/79 / EC on in vitro diagnostic medical devices (OJ No L 331 of 7 December 1998);
p.(None): 5. Directive 2000/70 / EC (OJ No L 313 of 13 December 2000);
p.(None): 6. Directive 2001/104 / EC (OJ No L 6, 10 January 2002);
p.(None): 7. Directive 2007/47 / EC (OJ No L 247 of 5 September 2007);
p.(None): 8. Directive 2011/24 / EU of the European Parliament and of the Council of 9 March 2011 on the
p.(None): Exercise of patient rights in cross-border healthcare (OJ № L 88
p.(None): from April 4, 2011 p. 45);
p.(None): 9. Commission Implementing Directive 2012/52 / EU of 20 December 2012 with measures to
p.(None): Facilitate the recognition of medical certificates issued in another Member State
p.(None): Prescriptions (OJ No L 356, 22.12.2012 p. 68).
p.(None): completion
p.(None): § 117. (1) With the enforcement of this federal law
p.(None): 1. the Federal Minister of Health and Consumer Protection,
p.(None): 2. with regard to § 10 and § 11 paragraph 3 under the conditions of § 12 of the Federal Minister for
p.(None): Work, health and social issues in agreement with the Federal Minister for Economic Affairs
p.(None): Affairs,
p.(None): 3. with regard to Section 80 (2), Section 81 (1) and Section 92, insofar as the electrotechnical safety stipulated by
p.(None): Measurement and calibration law covers measurement functions of medical devices and commercial law
p.(None): Provisions are concerned, and with regard to § 99 paragraph 1, as far as commercial law concerns
p.(None): are concerned, the Federal Minister of Health and Consumer Protection in agreement with the
p.(None): Federal Minister for Economic Affairs and
p.(None): 4. with regard to Section 98 (1) of the Federal Minister of Health and Consumer Protection in
p.(None): Agreement with the Federal Minister for Economic Affairs
p.(None): entrusted.
p.(None): (2) Before enacting ordinances in accordance with this federal law, those responsible pursuant to para
p.(None): Federal Minister to hear an advisory council, which, in addition to experts in the field of regulation
p.(None): In any case, a representative of the Federal Ministry of Economics and Labor, the
p.(None): Federal Ministry of Social Affairs and Consumer Protection, the Austrian Medical Association, the
p.(None): Austrian Chamber of Dentists, the Federal Chamber of Labor, the Austrian Chamber of Commerce, the
p.(None): Austrian Chamber of Pharmacists, the main association of Austrian social security institutions, the
p.(None): Austrian Agency for Health and Nutritional Security GmbH, business unit PharmMed, and
p.(None): belong to the Austrian Seniors' Council. Furthermore, they are according to the state law
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| armed forces | Soldier |
| army | Soldier |
| authority | Relationship to Authority |
| breastfeeding | breastfeeding |
| child | Child |
| children | Child |
| dependent | Dependent |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| employees | employees |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| gender | gender |
| hazard | Natural Hazards |
| home | Property Ownership |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| influence | Drug Usage |
| job | Occupation |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| mothers | Mothers |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| physically | Physically Disabled |
| pregnant | Pregnant |
| research staff | Laboratory Staff |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| union | Trade Union Membership |
| usage | Drug Usage |
| women | Women |
| youth | Youth/Minors |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| armed forces | ['army'] |
| army | ['armedXforces'] |
| child | ['children'] |
| children | ['child'] |
| drug | ['influence', 'substance', 'usage'] |
| illness | ['physically'] |
| impaired | ['impairment'] |
| impairment | ['impaired'] |
| influence | ['drug', 'substance', 'usage'] |
| minor | ['youth'] |
| physically | ['illness'] |
| substance | ['drug', 'influence', 'usage'] |
| usage | ['drug', 'influence', 'substance'] |
| youth | ['minor'] |
Trigger Words
consent
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input