0A4F4F9BD490A749D5437F821CF06DF1
Medical Devices Act (2014)
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10011003
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
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p.(None): the performance features of an in vitro diagnostic medical device are intended for the application for which it is intended.
p.(None): (5c) "Medical device with a derivative of human blood" is a medical device in accordance with Directive 90/385 / EEC or Directive 93/42 / EEC that
p.(None): as a component contains a substance that - used separately - as a pharmaceutical component or medicinal product from human blood or blood plasma in the sense of the
p.(None): Art. 1 point 10 of Directive 2001/83 / EC can be considered and in addition to the medical device can have an effect on the human body.
p.(None): The substance is referred to below as the “human blood derivative”.
p.(None): (6) “Custom-made products” are all medical devices, with the exception of in vitro diagnostic medical devices, which are prescribed by a doctor or someone else
p.(None): Because of their professional qualifications, the person authorized to do so under their responsibility is specially made according to specific design features
p.(None): and are intended for exclusive use in a named patient. Standard-made medical devices that are adapted
p.(None): to meet the speci fi c requirements of the doctor or other licensed user authorized to do so are not considered to be
p.(None): Custom made.
p.(None): (7) "Manufacturer" is any natural or legal person who is responsible for the design, manufacture, packaging and labeling of a medical device in the
p.(None): Responsible for the first placing on the market in your own name. 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 assembles, packs, treats, processes or prepares one or more prefabricated products
p.(None): indicates or is responsible for determining the intended use as a medical device with a view to placing it on the market in its own name.
p.(None): However, the manufacturer is not who - without being a manufacturer within the meaning of paragraph 7 - already placed products on the market for a named patient
p.(None): assembled or adapted according to its purpose.
p.(None): (8a) “Authorized representative” is the natural or legal person established in the European Economic Area (EEA), who is expressly authorized by the manufacturer
p.(None): was determined to act on his behalf with regard to his obligations under this federal law and that of the authorities and
p.(None): To be contacted in this sense in the EEA. If a manufacturer that markets a medical device in its own name does not have a seat in one
p.(None): Contracting party to the EEA, he must have a single authorized representative in the EEA in writing for at least all medical devices of the same model
p.(None): to name.
p.(None): (9) “Intended use” is the use for which the medical device is labeled according to the manufacturer's instructions and instructions for use
p.(None): or the advertising material is intended.
p.(None): (10) "Placing on the market" is the return of a medical device for or against payment or the readiness for the delivery. Placing on the market
p.(None): not before if
p.(None): 1. it is a medical device exclusively intended for clinical testing within the meaning of section 3 (3) or an in vitro diagnostic medical device for
p.(None): Performance evaluation purposes within the meaning of Section 3 (3a),
p.(None): 2. it is ensured by suitable measures that the medical device cannot reach the consumer, user or operator, or
p.(None): 3. Individual medical devices to a single specific person only free of charge and in the private sphere or in neighborhood help
p.(None): be passed on.
p.(None): (11) "First placing on the market" is the first placing on the market of a medical device or the first placing on the market of a medical device after it
p.(None): Reprocessing with a view to its distribution or 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): who places a medical device on the market for the first time within the scope of the Agreement on the European Economic Area and within the scope of the
p.(None): Agreement on the European Economic Area is established.
p.(None): (13) "Commissioning" is the phase in which a medical device is made available to the end user as a product that is first called
p.(None): ready-to-use medical device can be used in accordance with its intended use within the scope of the European Economic Area. at
p.(None): Active implantable medical devices are considered to be commissioning when they are made available to medical personnel for implantation.
p.(None): (14) “Exhibiting” is the setting up or demonstration of medical devices for the purpose of advertising or informing specialist circles.
p.(None): (15) "Harmonized standards" are national standards of the contracting states to the Agreement on the European Economic Area, the relevant ones
p.(None): carry out harmonized European standards, their references as "harmonized standards" for medical devices in the Official Journal of the European Communities
p.(None): have been published. Relevant monographs of the European Pharmacopoeia for Medical Devices, whose
p.(None): Finds have been published in the Official Journal of the European Communities. The Harmonized Standards are also the Common Technical
p.(None): Speci fi cations in accordance with Article 7 Paragraph 2 of Directive 98/79 / EC of the European Parliament and of the Council of October 27, 1998 on in vitro diagnostics
p.(None): (OJ L 331 of 7 December 1998) and published in the Official Journal of the European Communities. In these speci fi cations
p.(None): the criteria for the evaluation and reassessment of the performance, the batch release criteria, the reference methods and the
p.(None): Reference materials set.
p.(None): (16) "Notified Body" is one of a Contracting Party to the Agreement on the European Economic Area, the European Commission and
p.(None): the other contracting parties for the performance of tasks in the context of conformity assessment procedures for medical devices.
p.(None): (17) “Side effects” are those that occur and are related to the intended use of a medical device
p.(None): undesirable side effects.
p.(None): (18) "Mutual influence" means the effects of when used as intended
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 to preserve and restore the intended
p.(None): Target state as well as for determining and assessing the 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 assess the current state.
p.(None): (21) "Maintenance" of a medical device is the entirety of all measures to maintain the desired state, the perfect safety
p.(None): and functionality of the medical device is guaranteed.
p.(None): (22) "Repair" of a medical device are the measures for restoring the specified target state, which is the perfect safety and
p.(None): Functionality of the medical device guaranteed.
p.(None): (23) "Healthcare institution" means any institution, body or institution in which medical devices are made by health professionals or to them
p.(None): authorized business professionals are professionally operated or used, including those facilities of the Federal Army that provide medical supplies
p.(None): serve.
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p.(None): to investigate the safety and performance of the in vitro diagnostic medical device.
p.(None): (2b) “Clinical data” are safety or performance information that result from the use of a medical device and from the following sources
p.(None): come:
p.(None): 1. clinical trials of the medical device in question, or
p.(None): 2. clinical trials or other studies on a similar medical device, the
p.(None): Similarity to the medical device in question can be demonstrated, or
p.(None): 3. Published or unpublished reports of other clinical experiences either with the medical device in question or a similar one
p.(None): Medical device, the similarity of which can be demonstrated with the medical device in question.
p.(None): (3) "Medical device intended for clinical trials" is any medical device that is intended for a doctor qualified in the respective specialist area
p.(None): Conducting clinical trials of this medical device on humans in accordance with paragraph 2 in one of the intended medical application conditions
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 intended by the manufacturer to be one or more
p.(None): Performance assessment tests in medical analysis laboratories or in any other appropriate environment outside of your own facility
p.(None): to be subjected.
p.(None): (4) "Clinical investigator" is the doctor or dentist who is responsible for carrying out the clinical trial and in particular for the well-being of the patient
p.(None): Exam participant is responsible.
p.(None): (5) "Sponsor" is any natural or legal person who is responsible for the planning, initiation, implementation and financing of a
p.(None): clinical trial takes over. The sponsor must be established in a contracting party to the EEA. The clinical investigator has the duties and the
p.(None): Sponsor to assume additional responsibility if he has a clinical trial regardless of the manufacturer of the medical device and in full
p.(None): Carries out personal responsibility.
p.(None): (6) “Monitor” is a person designated by the sponsor who is responsible for monitoring and reporting on the progress of the clinical trial
p.(None): Exam is responsible.
p.(None): (7) “Clinical trial plan” or “protocol” is a document that provides detailed information on the reasons, intentions, goals, execution and intended
p.(None): Contains analyzes, methodology and conduct of the clinical trial.
p.(None): (7a) "Evaluation plan" is a document that provides detailed information about a planned performance assessment test, particularly with regard to the
p.(None): scientific, technical and medical justification, the goals, the methodology, the intended analysis and sampling, the test
p.(None): Contains performance criteria and requirements as well as the type and scope of the intended evaluation.
p.(None): (8) "Subject" is either a patient or a healthy subject who is taking a clinical trial or a performance assessment exam
p.(None): In vitro diagnostic agent participates.
p.(None): (9) “Ethics Committee” is an independent body composed of medical experts and others in accordance with Section 58 (4)
p.(None): Members whose job it is to assess whether there is a scientifically sound clinical trial and whether the safety of that
p.(None): Wellbeing, the rights and integrity of test takers are protected.
p.(None): (10) "Final report of the clinical trial" or "Final report" is a complete description and evaluation of the clinical trial after its
p.(None): Termination.
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p.(None): of the people who represent them.
p.(None): (8) The work of the delimitation and classification advisory board is conducted in accordance with rules of procedure to be adopted by the Federal Minister of Health.
p.(None): (9) The activity in the delimitation and classification advisory board is voluntary, without prejudice to paragraph 10. Any travel expenses are the members of the
p.(None): Delimitation and classification advisory board, its deputies and experts involved according to the highest fee level of the 1955 travel fee regulation,
p.(None): Federal Law Gazette No. 133, to be replaced on request.
p.(None): (10) The members of the Delimitation and Classification Advisory Board, which are created by the Federal Office for Safety in Health Care with the creation of
p.(None): relevant appraisals are due, due to the effort and the amount of time appropriate compensation, which the applicant
p.(None): has to carry.
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 erect, to install, to put them into operation or to use them if
p.(None): 1. there is reasonable suspicion that they meet the basic requirements within the meaning of sections 8 and 9 and a regulation according to section 10 or if applicable
p.(None): do 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 put into operation in healthcare facilities in accordance with Section 112,
p.(None): if the person responsible for the initial placing on the market is based in a contracting party to the Agreement on the European Economic Area.
p.(None): (2) The provisions of Section 6 (2) and (1) do not apply to the Federal Army when deployed in accordance with Section 2 (1) lit. a of the Wehrgesetzes 2001, Federal Law Gazette I № 146,
p.(None): as well as in the immediate preparation of this mission.
p.(None): basic requirements
p.(None): § 8. (1) Medical devices must be designed and manufactured in such a way that their use does not affect the clinical condition or the safety of the patient
p.(None): endangers the safety of users or third parties if they are used under the intended conditions and for the intended purposes. any
p.(None): Risks and side effects that can occur with the intended installation, implantation or application must be taken into account
p.(None): Effectiveness of medical devices according to the state of the medical sciences and technology to be justifiable and protection of health and safety
p.(None): must be guaranteed.
p.(None): (2) Medical devices must be designed, manufactured and packaged in such a way that they are suitable for the medical services specified by the manufacturer
p.(None): according to § 2 paragraph 1 or 5, if they are exposed to loads that are normal and under the conditions provided by the manufacturer
p.(None): Transport and storage conditions can occur.
p.(None): (3) The design and construction of medical devices must take into account the generally recognized state of science and technology
p.(None): according to the principles of integrated security. When choosing the most appropriate solutions for design and construction are given in the
p.(None): Order to apply the following principles:
p.(None): 1. Elimination or minimization of risks by integrating the safety concept into the development and construction of the medical device,
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p.(None): Users and third parties or the prevention of significant risks is required by regulation conformity assessment procedures for medical devices for in-vitro
p.(None): Prescribe diagnosis as a prerequisite for placing on the market and commissioning and specify its type. Content and implementation.
p.(None): Section 29. (1) Sets the conformity assessment procedure in accordance with an ordinance in accordance with Section 28 (1) or the procedure in accordance with Sections 33 to 35
p.(None): Involvement of a notified body, the manufacturer or his authorized representative can contact a body designated for the performance of these tasks
p.(None): Turn choice. The simultaneous referral of several notified bodies as part of a conformity assessment procedure for a medical device by the
p.(None): Manufacturer or his authorized representative is not permitted.
p.(None): (2) In the conformity assessment procedures for a medical device, the manufacturer or the notified body has the results of assessments and
p.(None): Consider tests, which may be in an intermediate stage of manufacture in accordance with this federal law or other Austrian
p.(None): Regulations within the meaning of Section 112 (1) and (2) have been made.
p.(None): (3) At the reasoned request, all information or details relating to the exhibition are to be submitted to or made available to the notified body
p.(None): the certificate of conformity and maintenance of the conformity decision with regard to the selected procedure are required.
p.(None): (4) The documents and correspondence regarding the procedures for conformity assessment are provided that they are within the scope of this Federal Act
p.(None): be carried out in German 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 authorized representative established in the European Economic Area must do so before the first
p.(None): Issue the declaration provided for in a regulation pursuant to Section 28 and make the documentation listed there available. From the
p.(None): Documentation must include the design, manufacture and performance data of the medical device including the intended performance in the manner
p.(None): show that it enables an assessment to be made as to whether the requirements of this federal law have been met.
p.(None): (2) The manufacturer must take all necessary measures to ensure that the medical device manufactured complies with the
p.(None): Documentation is ensured in accordance with a regulation according to § 28. 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 a notification of all custom-made products in accordance with Directive 93/42 / EEC
p.(None): claims that have been put into operation or placed on the market within the scope of this federal law.
p.(None): Section 5
p.(None): Exhibit; Exemptions in the interest of health protection; Systems and treatment centers; Sterilization for that
p.(None): marketing
p.(None): Exhibit
p.(None): Section 31. (1) Medical devices that do not comply with sections 15 and 27 may then be used for demonstration purposes, especially at trade fairs, exhibitions,
p.(None): Demonstrations and scientific or medical technology events will be issued if a visible sign indicates that this
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p.(None): carry out according to this federal law.
p.(None): (2) Insofar as the bodies or facilities in accordance with Paragraph 1 are accredited bodies within the meaning of the Accreditation Act, the
p.(None): Monitoring by the Federal Minister for Health and Consumer Protection in agreement with the Federal Minister for Economic Affairs in the
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 have all aspects to the subject, which the proper execution of the test, surveillance and
p.(None): Certi fi cation activities in accordance with this federal law and the guarantee of medical device safety. In particular, it can affect the
p.(None): Monitoring the existence of the necessary prerequisites for carrying out testing, monitoring and certi fi cation activities in accordance with this
p.(None): Federal law extend. Section 68 paras. 3 and 4 and 6 to 9 apply mutatis mutandis.
p.(None): Section 3
p.(None): Reporting requirements, recording and evaluation of reports; investigations
p.(None): Announcements
p.(None): Section 70. (1) Relatives of a legally regulated health care profession, business beneficiaries who are professionally responsible for operating or using a
p.(None): Medical devices are authorized, heads of relevant 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 as any defect in relation to the labeling or the
p.(None): Instructions for use that are suitable for the death or serious deterioration of a patient's health, one
p.(None): 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 serious side effects, or
p.(None): 3. previously unknown mutual influences, or
p.(None): 4. serious quality defects,
p.(None): who have become aware of them as a result of their professional activities must be reported immediately to the Federal Office for Safety in Health Care and all
p.(None): Communicate observations and data that may be important for medical device safety.
p.(None): (2) Reports in accordance with paragraph 1 have to be made uniformly by the medical director at hospitals, unless there is any other imminent danger.
p.(None): (3) All natural or legal persons who place medical devices on the EEA for the first time and those companies, facilities or persons who
p.(None): Placing medical devices on the market has the Federal Office for Safety in Healthcare immediately incidents according to paragraph 1 and beyond
p.(None): corrective measures, such as
p.(None): 1. Any technical or medical reason associated with a medical device that leads to the systematic recall of medical devices of the same
p.(None): Type of the market led by the manufacturer,
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 to ensure that the first-time placing on the market in the EEA
p.(None): Responsible person is also informed of an incident in accordance with paragraph 1.
p.(None): (5) Insofar as it is necessary to ensure the uniformity and the information content of the reports, the Federal Minister of Health and
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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 the prevention of risks,
p.(None): 8.Maintenance of medical devices in healthcare facilities and at other operators or users,
p.(None): 9. Measures for quality management in the manufacture and other handling of 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 the operational processes relevant for medical devices.
p.(None): (3) In a regulation according to paragraph 1 it should also be provided that certain companies manufacture and store and trade in medical devices
p.(None): may only begin if they have obtained approval from the Federal Office for Safety in Health Care. It can be provided
p.(None): that the authorization is only required for the trade or wholesale of certain types or groups of medical devices. In a regulation according to
p.(None): Paragraph 1 are also the prerequisites for the approval, insofar as this includes the safety, quality and functionality of the medical devices and the safety
p.(None): and the health of patients, users or third parties. It is based on expertise, reliability and organizational
p.(None): Take special care to ensure the requirements for ensuring medical device safety.
p.(None): (4) If the Federal Office for Safety in Health Care determines that in companies within the meaning of paragraph 1 that of a regulation in accordance with paragraph 2 in each case
p.(None): specified requirements are not complied with and this results in a not inconsiderable risk to the health and safety of patients and users
p.(None): or a third party grows up, the Federal Office for Safety in Health Care can close the business, unless other measures are sufficient
p.(None): can be found. If the violation of the requirements laid down in a regulation in accordance with paragraph 2 leads to an immediate threat to the
p.(None): Health, these measures can also be taken without a previous procedure. However, this is reasoned within four weeks
p.(None): To issue notice.
p.(None): (5) The regulations in paragraphs 1 to 4 also apply to persons who professionally perform the activities listed in paragraph 1.
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, taking into account the protection of the safety and health of patients,
p.(None): Users or third parties, to ensure the required quality of medical devices and taking into account the requirements for delivery,
p.(None): in particular with regard to information, instruction, installation or functional testing as well as with regard to suitable precautions to avert risks in the
p.(None): Agreement with the Federal Minister of Economic Affairs by ordinance to stipulate that certain types of medical devices should be used only
p.(None): certain businesses or pharmacies may be sold or that a person is available to dispense the medical device
p.(None): whose training and practical experience is determined by this regulation. 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 can also determine that certain types of
p.(None): Medical devices may not be dispensed by self-service, by vending machines or by mail order.
p.(None): (2) The Federal Minister of Health and Consumer Protection has for medical devices, their installation, commissioning, operation, use or use
p.(None): Is reserved for members of the health professions or healthcare facilities, or for their safe and intended use or use only
p.(None): is guaranteed by health care institutions, by regulation on the protection of human health and safety, to stipulate that the
p.(None): These medical devices may only be given to these persons or institutions.
p.(None): § 100. The Federal Minister of Health and Consumer Protection has by ordinance for medical devices for use or use by laypersons
p.(None): are provided and the
p.(None): 1. Can directly or indirectly endanger human health even when used as intended if they are without medical or
p.(None): dental surveillance may be used, or their application may require 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 directly or indirectly affects the health of people
p.(None): is endangered
p.(None): to stipulate that they may only be given with a prescription.
p.(None): § 100a. (1) A patient requests a prescription (prescription) to be presented in another party to the Agreement on the European Economic Area
p.(None): To use it must contain at least:
p.(None): a) the name and details of the professional qualification and professional seat of the prescribing doctor or dentist, together with his email address and
p.(None): Telephone or fax number with international code,
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 prescribed 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) Prescriptions within the meaning of Section 100 also include prescriptions that are in other contracting parties to the Agreement on the European Economic Area
p.(None): issued by a person authorized to prescribe there taking into account the information in paragraph 1 for cross-border use 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 work in healthcare facilities to:
p.(None): The purpose of collecting orders for medical devices without a medical prescription is prohibited. It is also prohibited that
p.(None): Order to do so.
p.(None): Section 3
p.(None): Advertising for medical devices
p.(None): misleading
p.(None): Section 102. (1) It is prohibited to label or put up medical devices in connection with the placing on the market
p.(None): or to provide information about this which does not correspond to the facts or is 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): 2. the impression is erroneously given that success is to be expected with certainty or that, when used as intended, no harmful effects
p.(None): Effects will occur or
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p.(None): d) measures to ensure the safety of medical devices and to avert risks, in particular also in accordance with Section 72,
p.(None): e) the information and advertising material on the market,
p.(None): f) the performance of testing, monitoring and certification activities in accordance with this Federal Act,
p.(None): g) the conformity assessment,
p.(None): h) the fulfillment of the basic requirements within the meaning of §§ 8 and 9 and a regulation according to § 10 and others for medical device safety
p.(None): relevant information
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 and the organs of the
p.(None): Federal Office for Safety in Health Care, the 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 required to make the premises, medical devices and records available to them
p.(None): to allow prescribed or officially ordered testing, to provide the necessary staff and aids for this, and to provide the information and
p.(None): to submit the documents necessary for the performance of the tasks of the bodies responsible for monitoring or of the experts commissioned in accordance with paragraph 2
p.(None): required are.
p.(None): (9) The official acts in accordance with paragraphs 5 to 8 are, except in the event of imminent danger or if there is a reasonable assumption that the effectiveness of the
p.(None): Official action is impaired to perform during the operating hours and to announce beforehand. The organs and the experts according to paragraph 2 have
p.(None): in the course of their surveillance, taking care that any disruption or hindrance to the activities of undertakings which is not absolutely
p.(None): Facilities or persons in accordance with paragraph 1 is avoided.
p.(None): (10) The Federal Minister of Health and Women has from the point of view of an expedient and effective control for the following
p.(None): To issue a directive on the implementation of the inspections (inspection plan) during the calendar year. 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 March 31 of the following calendar year on enforcement
p.(None): to report.
p.(None): (11) Market surveillance authority within the meaning of Regulation (EC) № 765/2008 of the European Parliament and of the Council of 9 July 2008 on the
p.(None): Regulations for accreditation and market surveillance in connection with the marketing of products and repealing the regulation (EEC)
p.(None): No. 339/93 for products within the meaning of this federal law is the Federal Office for Safety in Health Care.
p.(None): (12) The Federal Office for Safety in Health Care has in accordance with the requirements of the Federal Ministry of Health
p.(None): Develop market surveillance programs for medical devices and regularly update and implement them. These are the Federal Minister for
p.(None): Submit health for approval. The Federal Office for Safety in Healthcare has these programs in the other Member States and the
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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 may, upon request, place the product on the market and the
p.(None): Commissioning of individual medical devices, for which the conformity assessment procedure according to a regulation according to § 28 was 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 sufficient care in the ordinance pursuant to Section 28, taking into account
p.(None): with safe and efficient medical devices 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 detailed conditions under which the exemption according to paragraph 1 can be granted and also therein
p.(None): To regulate the type and content of the applications and 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 in the immediate preparation of this mission is for the
p.(None): Placing on the market and putting individual medical devices required for this case into use does not require an exemption according to paragraph 1.
p.(None): (4) An exemption within the meaning of paragraph 1 is not required if a doctor authorized to practice his or her profession independently in Austria
p.(None): confirms that a medical device is intended to avert a life threatening or a serious impairment of the patient
p.(None): Health is required and the success of treatment with a medical device, on which the procedures according to §§ 15 and 27 have already been carried out,
p.(None): probably cannot be achieved.
p.(None): Systems and treatment centers; Sterilization for placing on the market
p.(None): § 33. (1) Any natural or legal person, each with a CE-marked medical device in accordance with Directive 93/42 / EEC
p.(None): their intended purpose and within the application restrictions laid down by the manufacturer to form them in the form of a system or a
p.(None): Placing the treatment center on the market for the first time must provide an explanation of the content that:
p.(None): 1. They checked the mutual compatibility of the medical devices according to the instructions of the manufacturers and the work steps according to the
p.(None): Carried out notices,
p.(None): 2. It packs the system or the treatment center and pertinent user instructions, including the relevant instructions from the manufacturer,
p.(None): gave 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 that do not have a CE marking within the meaning of this
p.(None): Federal law or placed on the market for the first time in a type and form that is not the original purpose and that of the manufacturer
p.(None): corresponds to the intended application restrictions, the system or treatment unit is treated as an independent medical device and
p.(None): As such, it is subject to the provisions of a regulation pursuant to 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 other medical devices of the directive 93/42 / EEC
...
p.(None): (2) The Federal Office for Safety in Health Care, if it suspends or prohibits the conduct of a clinical trial, the others
p.(None): Contracting parties of the EEA, the responsible ethics committee, and the European Commission, stating the reasons for its decision, the clinical
p.(None): Suspend or prohibit examination, inform. The Federal Office for Health Safety has made a major change to a clinical
p.(None): Ordered, it has the other contracting parties of the EEA, in whose territory the clinical trial is carried out, as well as the competent
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 or the clinical investigator or anyone else at the
p.(None): clinical trial participants no longer fulfilled their obligations, 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 also applies if the clinical trial is already
p.(None): has ended. Reporting obligations according to paragraph 2 remain unaffected.
p.(None): general requirements
p.(None): Section 41. (1) When planning, setting up and conducting clinical trials, the health risks and burdens for the trial participants are so
p.(None): to keep it as low as possible.
p.(None): (2) The clinical trial of medical devices may only be carried out if the risks associated with it for the trial participants
p.(None): measured by the expected significance of the result of the test for medicine and the risk of impairment that cannot be ruled out
p.(None): the health of these subjects
p.(None): 1. is not significant or
p.(None): 2. is outweighed by the health benefits to be assumed from the use of the medical device.
p.(None): (3) The clinical trial of medical devices may only be carried out on patients if the medical device is used in accordance with the
p.(None): Medical science evidence is appropriate to the patient on whom the clinical trial is being performed
p.(None): to be reached according to § 2 paragraph 1.
p.(None): (4) The clinical trial of a medical device may only be carried out if all necessary in connection with the clinical trial
p.(None): Precautions to protect the life, health and safety of test takers, users or third parties have been taken and that
p.(None): Medical device with the exception of the aspects that are the subject of the clinical trial, the basic requirements according to §§ 8 and 9 and one
p.(None): Regulation according to § 10 corresponds.
p.(None): (5) The manufacturer of a medical device intended for clinical trials must take all necessary measures to ensure that the
p.(None): Ensure compliance of the medical devices manufactured with the documentation in accordance with an ordinance pursuant to Section 66. He has an evaluation of the
p.(None): To allow the effectiveness of these measures and, if necessary, an inspection by the Federal Office for Safety in Health Care.
p.(None): (6) In the planning, installation, implementation and evaluation of clinical trials of medical devices and performance assessment tests of in-
p.(None): Vitro diagnostics are the ethical principles for medical research on humans in the Helsinki Declaration of the World Medical Association, in which
p.(None): Version of the 59th General Assembly of the World Medical Association, Seoul, October 2008.
p.(None): methods
...
p.(None): Pain, discomfort, fear and other foreseeable risks are connected, whereby the risk threshold as well as the degree of exposure are specific
p.(None): must be defined and constantly checked,
p.(None): 9. The test plan from an ethics committee that has knowledge in the field of pediatrics and adolescent medicine or that is in clinical, ethical
p.(None): and psychosocial issues in the field of paediatrics and adolescent medicine was advised, endorsed, and
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of science.
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 a significant extension of the scientific understanding of the condition, the illness or the disorder of the minor
p.(None): aims and can thereby benefit either the patient or the patient group to which the minor belongs, and
p.(None): 2. the clinical trial brings minimal risk and burden to the minor; a clinical trial shows a minimal
p.(None): Risk and a minimal burden, if it can be expected that they lead to a minor and only temporary impairment
p.(None): and any symptoms or inconveniences may be very minor and will only occur temporarily.
p.(None): § 52. The clinical trial may be carried out on a person who is suffering from a mental illness or a comparable impairment of their
p.(None): Ability to make decisions has a legal representative or has been stopped by judicial or official order or in accordance with the Accommodation Act,
p.(None): BGBl. No. 155/1990, is not carried out.
p.(None): Section 52a. (1) A clinical trial of its kind can only be used in emergency situations in which, within a reasonable time, no consent of the legal representative
p.(None): can be obtained, a clinical trial can then be performed on a person who is unable to consent,
p.(None): if
p.(None): 1. There are no indications that either the patient refused or would refuse the clinical trial or that the requirements of the
p.(None): § 52 exist,
p.(None): 2. Such research for the validation of data used in clinical trials on persons capable of obtaining informed consent or by means of
p.(None): other research methods have been obtained and are essential 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 is intended to fulfill an intended purpose within the meaning of Section 2 (1) nos. 1 to 3 in an emergency situation,
p.(None): 4. The application of the medical device that is being tested, based on the knowledge of medical science, is indicated to 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): Consumer Protection Act - LMSVG, Federal Law Gazette I No. 13/2006)
p.(None): 3. human blood, blood products, blood plasma or blood cells of human origin or products at the time of placing on the market
p.(None): Contain blood products, blood plasma or blood cells of this type, with the exception of in vitro diagnostics and medical devices within the meaning of Section 2 (5c),
p.(None): 4. Organs, tissues or cells of human origin as well as products containing or from tissues or cells of human origin
p.(None): Tissues or cells have been obtained, unless 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 using killed animal tissue or
p.(None): manufactured from killed products derived from animal tissue or in vitro diagnostic medical devices,
p.(None): 6. Natural healing deposits and products from a natural healing deposit within the meaning of Section 42a (2) of the Federal Act on Hospitals and
p.(None): Kuranstalten, BGBl. 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 the manufacturer also uses according to the regulations on personal
p.(None): Protective equipment specified in Directive 89/686 / EEC are also subject to the provisions of this federal law.
p.(None): (2) Medical devices in accordance with Directives 90/385 / EEC and 93/42 / EEC, which also include machines as defined in Article 2 letter a of Directive 2006/42 / EC
p.(None): are subject to the provisions of this federal law.
p.(None): Differentiation from drug regulations
p.(None): § 5. (1) Medical devices that do not contain any medicinal products at the time of delivery, but are intended to be a medicinal product within the meaning of the
p.(None): Applying the Medicines Act are subject to this Federal Act without prejudice to the provisions of the Medicines Act that apply to medicinal products.
p.(None): (2) If a combination of medical device and medicinal product is placed on the market in such a way that the medical device and the medicinal product are uniform, together
p.(None): form a combined product, the intended main effect of which is based on the chemical composition of the medicinal product and which is used exclusively for
p.(None): Use in this compound is intended and is not reusable, so this product is subject to the Medicines Act. The Federal Office for Security in
p.(None): Health care has the basic requirements according to the II. Main part of this federal law when assessing the medical device part
p.(None): apply as far as safety and performance-related medical device functions are affected.
p.(None): (3) Does a medical device - with the exception of in vitro diagnostic medical devices - contain a substance as an integrated component, which - used separately - as a pharmaceutical in
p.(None): According to the Medicines Act and in addition to the medical device, it can have an effect on the human body
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 (5c), this medical device is also subject to it
p.(None): 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 his authorized representative in the event of the intended
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Searching for indicator influence:
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p.(None): Active implantable medical devices are considered to be commissioning when they are made available to medical personnel for implantation.
p.(None): (14) “Exhibiting” is the setting up or demonstration of medical devices for the purpose of advertising or informing specialist circles.
p.(None): (15) "Harmonized standards" are national standards of the contracting states to the Agreement on the European Economic Area, the relevant ones
p.(None): carry out harmonized European standards, their references as "harmonized standards" for medical devices in the Official Journal of the European Communities
p.(None): have been published. Relevant monographs of the European Pharmacopoeia for Medical Devices, whose
p.(None): Finds have been published in the Official Journal of the European Communities. The Harmonized Standards are also the Common Technical
p.(None): Speci fi cations in accordance with Article 7 Paragraph 2 of Directive 98/79 / EC of the European Parliament and of the Council of October 27, 1998 on in vitro diagnostics
p.(None): (OJ L 331 of 7 December 1998) and published in the Official Journal of the European Communities. In these speci fi cations
p.(None): the criteria for the evaluation and reassessment of the performance, the batch release criteria, the reference methods and the
p.(None): Reference materials set.
p.(None): (16) "Notified Body" is one of a Contracting Party to the Agreement on the European Economic Area, the European Commission and
p.(None): the other contracting parties for the performance of tasks in the context of conformity assessment procedures for medical devices.
p.(None): (17) “Side effects” are those that occur and are related to the intended use of a medical device
p.(None): undesirable side effects.
p.(None): (18) "Mutual influence" means the effects of when used as intended
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 to preserve and restore the intended
p.(None): Target state as well as for determining and assessing the 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 assess the current state.
p.(None): (21) "Maintenance" of a medical device is the entirety of all measures to maintain the desired state, the perfect safety
p.(None): and functionality of the medical device is guaranteed.
p.(None): (22) "Repair" of a medical device are the measures for restoring the specified target state, which is the perfect safety and
p.(None): Functionality of the medical device guaranteed.
p.(None): (23) "Healthcare institution" means any institution, body or institution in which medical devices are made by health professionals or to them
p.(None): authorized business professionals are professionally operated or used, including those facilities of the Federal Army that provide medical supplies
p.(None): serve.
p.(None): Definitions for the clinical evaluation and testing of medical devices as well as for the performance evaluation 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 Annex 7 № 1.1 of the Council Directive 90/385 / EEC
p.(None): of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ. EG № L 189 of July 20, 1990,
...
p.(None): To put knowledge.
p.(None): Minimum criteria for notified bodies
p.(None): Section 37. (1) The notified body, its manager and the personnel responsible for carrying out the assessments and tests must be independent of the body
p.(None): be the one who developed or designed the medical device to be assessed, as well as its manufacturer, distributor, installer or user You may not
p.(None): directly as a representative for the development or construction, for the manufacture, for distribution or for the applicant for the maintenance of these
p.(None): Products to be involved. This does not make it possible to exchange technical information between the manufacturer and the notified body
p.(None): locked out.
p.(None): (2) The notified body must be able to perform all the tasks provided for in a conformity assessment procedure in accordance with an ordinance pursuant to Section 28
p.(None): be assigned to such a body and for which it is designated, be it that these tasks are performed by the notified body itself or be that it is in
p.(None): Sub-areas are carried out under their responsibility. In particular, it must have the personnel and the resources necessary to meet the requirements of the
p.(None): Carrying out the assessments and examinations associated with medical-scientific, technical and administrative tasks are required. she
p.(None): must have the equipment required for testing and monitoring, but may use external facilities in some areas if
p.(None): access to these is regulated and their suitability is ensured.
p.(None): (3) The body and the personnel commissioned with the examination must carry out the evaluations and examinations with the necessary expertise and reliability
p.(None): in the field of medical devices and 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, after establishing agreement with the client, a notified body carries out certain work in connection with the
p.(None): Conformity assessment to a subcontractor, it must first ensure that the provisions of this section are from the subcontractor
p.(None): be respected. The notified body has the relevant documents for assessing the technical competence of the subcontractor and on the latter's
p.(None): To have work carried out within the scope of this federal law available for inspection by the responsible authorities.
p.(None): (5) Parts of conformity assessment procedures to be subcontracted may only make up the smaller part of the overall order. The
p.(None): Overall responsibility for carrying out a conformity assessment procedure must be borne by the notified body.
p.(None): (6) The personnel responsible for the examinations must meet the following requirements:
p.(None): 1. the professional qualifications required for the assessments and examinations for which the position has been designated,
p.(None): 2. Adequate knowledge of the rules for the tests he has carried out and sufficient practical experience in this field, and
p.(None): 3. those for the conduct of the tests and the drafting of certificates, minutes and reports in which the tests carried out
p.(None): be laid down, required suitability.
p.(None): (7) The independence of the personnel commissioned with the examination must be ensured. The amount of the remuneration of each auditor may not vary according to the number of
p.(None): the tests he carries out are still based on the results of these tests
p.(None): (8) The notified body must take out sufficient liability insurance for liability cases that may arise from its activities, unless
p.(None): this liability is covered by the Republic of Austria.
...
p.(None): be started. With the performance evaluation test of in vitro diagnostic medical devices according to the directive 98/79 / EG, which carry the CE marking according to § 15
p.(None): - provided that the performance assessment test does not serve any other purpose of the in vitro diagnostic medical device than the one intended in the conformity assessment
p.(None): The subject has to be started - after a favorable opinion has been given by the responsible ethics committee. Section 47 does not apply.
p.(None): (6) The sponsor has given the Federal Office for Safety in Health Care and the competent authorities of other parties to the EEA contract
p.(None): Completion of the clinical trial, in the event of early termination, with a justification, to be reported. This message also sent to the
p.(None): competent authorities of all other EEA contracting parties and the European Commission to take place if the early termination comes from
p.(None): Security reasons. The final report in accordance with section 2.3.7 of Annex 7 to Directive 90/385 / EEC or section 2.3.7 of Annex X to
p.(None): Directive 93/42 / EEC is for the Federal Office for Safety in Health Care and the competent authorities of the other contracting parties to the EEA
p.(None): ready injury.
p.(None): (7) Reports in accordance with paragraphs 1, 2, 3 and 6, § 40b and § 42 paragraph 8 must be in accordance with a regulation in accordance with § 67 by means of the European database for
p.(None): Medical devices are made.
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 change is significant and specifically affects the
p.(None): The sponsor has to influence the safety of the trial participants or influence the scientific significance of the clinical trial
p.(None): Examinations in accordance with section 40 (2) and (3) of the Federal Office for Safety in Health Care and the responsible ethics committee check the content of the change and
p.(None): to report all reasons for this. In the case of clinical trials according to Section 40 (5), 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 in accordance with Section 40 (2), the change may result in a notification after the approval of the responsible ethics committee
p.(None): in accordance with paragraph 1, provided the Federal Office for Safety in Health Care is not within a period of 35 days after proper
p.(None): Notification of the change in the clinical trial to protect subjects, public health or other non-existence of the
p.(None): Has prohibited the requirements of section 41 (4) or approved the implementation of the change before this period has expired.
p.(None): (3) In the case of a clinical trial pursuant to Section 40 (3), the change may result in a notification after the approval of the responsible ethics committee
p.(None): in accordance with paragraph 1 and the reporting in accordance with paragraph 1 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 may result in a notification after the approval of the responsible ethics committee
p.(None): according to paragraph 1.
...
p.(None): / Utilities are at least partially reimbursed in costs, and
p.(None): 2. Institutions that use life-saving or other health-relevant medical devices in their or in a public area for use
p.(None): keep ready,
p.(None): to take the necessary precautions for their proper maintenance. The Federal Minister of Health and Women made the determination
p.(None): of these medical devices in a regulation in accordance with Section 92 each on significant risks to the health and safety of patients and on
p.(None): Take into account any deterioration in the performance of these medical devices that would be expected in the absence of proper maintenance. In the
p.(None): Ordinance according to § 92 may also have special requirements with regard to the proper preparation and use of these medical devices and
p.(None): regarding the required training measures.
p.(None): § 86. After the repair of medical devices, the essential structural and functional requirements for safety and functionality
p.(None): Features are checked as far as they can be affected by the repair.
p.(None): Recurring safety-related tests of medical devices
p.(None): Section 87. Health care institutions must ensure that medical devices listed in an ordinance pursuant to Section 92 are of an appropriate type
p.(None): technically suitable person or position are checked regularly.
p.(None): § 88. (1) The tests in accordance with § 87 have considering the type of the medical device to be tested and the information of the manufacturer in one
p.(None): The scope is sufficient to be able to assess the safety and functional condition of the medical device. Accessories or
p.(None): Product combinations that can influence the medical device to a significant degree in safety must be taken into account.
p.(None): (2) The Federal Minister of Health and Consumer Protection has in the regulation according to § 92 with regard to the safety of patients, users and
p.(None): Third, and the proper condition of medical devices to designate those types, groups, or classes of medical devices that are regular
p.(None): Checks must be submitted and minimum requirements for the type, scope, implementation and intervals of periodic inspections must be specified.
p.(None): Evaluation and documentation of the tests; device file
p.(None): Section 89. (1) Health care institutions must keep a list of devices for the active medical devices to be tested regularly.
p.(None): (2) The device directory in accordance with paragraph 1 can be kept in one with the inventory in accordance with § 84.
p.(None): (3) Recurring tests, tests after repair or after incidents and their results are to be documented and in the
p.(None): List of devices. The intervals of recurring tests and briefings according to § 83 must also be kept evident in the device directory.
p.(None): Suitability for exams
p.(None): Section 90. (1) Only persons who:
p.(None): 1. on the basis of their professional training and their experience gained through practical work in the testing of medical devices as well as their
p.(None): Knowledge, especially with regard to 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 necessary organizational requirements for planning, implementation and
p.(None): Evaluation of the exams
...
Searching for indicator substance:
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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): used for the in vitro examination of samples from the human body, including blood and tissue donations, and
p.(None): 2. serves solely or predominantly to
p.(None): (a) provide information about physiological or pathological conditions or congenital anomalies, 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, which are specifically designed for in-vitro analysis from the manufacturer by the manufacturer are also considered to be in-vitro diagnostics
p.(None): human body samples are intended as a primary container for storage. Products for general laboratory needs are not considered
p.(None): Vitro diagnostics, unless, due to their characteristics, they are intended for in vitro investigations in accordance with their intended purpose specified by the manufacturer
p.(None): to use the Z 2.
p.(None): (5a) "In vitro diagnostic medical device for personal use" is any in vitro diagnostic medical device that is designed according to the intended purpose of the layperson in the
p.(None): home environment can be applied.
p.(None): (5b) "Calibration and control material" are substances, materials and objects that are used by their manufacturer to compare measurement data or for testing
p.(None): the performance features of an in vitro diagnostic medical device are intended for the application for which it is intended.
p.(None): (5c) "Medical device with a derivative of human blood" is a medical device in accordance with Directive 90/385 / EEC or Directive 93/42 / EEC that
p.(None): as a component contains a substance that - used separately - as a pharmaceutical component or medicinal product from human blood or blood plasma in the sense of the
p.(None): Art. 1 point 10 of Directive 2001/83 / EC can be considered and in addition to the medical device can have an effect on the human body.
p.(None): The substance is referred to below as the “human blood derivative”.
p.(None): (6) “Custom-made products” are all medical devices, with the exception of in vitro diagnostic medical devices, which are prescribed by a doctor or someone else
p.(None): Because of their professional qualifications, the person authorized to do so under their responsibility is specially made according to specific design features
p.(None): and are intended for exclusive use in a named patient. Standard-made medical devices that are adapted
p.(None): to meet the speci fi c requirements of the doctor or other licensed user authorized to do so are not considered to be
p.(None): Custom made.
p.(None): (7) "Manufacturer" is any natural or legal person who is responsible for the design, manufacture, packaging and labeling of a medical device in the
p.(None): Responsible for the first placing on the market in your own name. 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 assembles, packs, treats, processes or prepares one or more prefabricated products
p.(None): indicates or is responsible for determining the intended use as a medical device with a view to placing it on the market in its own name.
p.(None): However, the manufacturer is not who - without being a manufacturer within the meaning of paragraph 7 - already placed products on the market for a named patient
p.(None): assembled or adapted according to its purpose.
p.(None): (8a) “Authorized representative” is the natural or legal person established in the European Economic Area (EEA), who is expressly authorized by the manufacturer
p.(None): was determined to act on his behalf with regard to his obligations under this federal law and that of the authorities and
...
p.(None): § 4a. (1) Medical devices according to Directive 93/42 / EEC, which the manufacturer also uses according to the regulations on personal
p.(None): Protective equipment specified in Directive 89/686 / EEC are also subject to the provisions of this federal law.
p.(None): (2) Medical devices in accordance with Directives 90/385 / EEC and 93/42 / EEC, which also include machines as defined in Article 2 letter a of Directive 2006/42 / EC
p.(None): are subject to the provisions of this federal law.
p.(None): Differentiation from drug regulations
p.(None): § 5. (1) Medical devices that do not contain any medicinal products at the time of delivery, but are intended to be a medicinal product within the meaning of the
p.(None): Applying the Medicines Act are subject to this Federal Act without prejudice to the provisions of the Medicines Act that apply to medicinal products.
p.(None): (2) If a combination of medical device and medicinal product is placed on the market in such a way that the medical device and the medicinal product are uniform, together
p.(None): form a combined product, the intended main effect of which is based on the chemical composition of the medicinal product and which is used exclusively for
p.(None): Use in this compound is intended and is not reusable, so this product is subject to the Medicines Act. The Federal Office for Security in
p.(None): Health care has the basic requirements according to the II. Main part of this federal law when assessing the medical device part
p.(None): apply as far as safety and performance-related medical device functions are affected.
p.(None): (3) Does a medical device - with the exception of in vitro diagnostic medical devices - contain a substance as an integrated component, which - used separately - as a pharmaceutical in
p.(None): According to the Medicines Act and in addition to the medical device, it can have an effect on the human body
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 (5c), this medical device is also subject to it
p.(None): 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 his authorized representative in the event of the intended
p.(None): first placing a product on the market to determine whether that product fulfills one of the definitions according to § 2 Paragraphs 1 to 6 and, if necessary, via the
p.(None): Decide on the classification and classi fi cation of the medical device. The manufacturer or his authorized representative must be domiciled in Germany. in the
p.(None): As part of this procedure, it can obtain an opinion from the Delimitation and Classification Advisory Board in accordance with Section 5b.
p.(None): (2) The Federal Office for Safety in Health Care may make ex officio determinations in accordance with paragraph 1. It can also be a
p.(None): Obtain the opinion of the delimitation and classification advisory board in accordance with § 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 Health Care on issues relating to the delimitation of
p.(None): Medical devices for other products as well as for the preparation of reports on whether a product fulfills one of the definitions according to § 2 Paragraphs 1 to 6 and
...
Searching for indicator usage:
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p.(None): Section 1
p.(None): scope of application
p.(None): § 1. This federal law regulates the functionality, performance, safety and quality, the manufacture, the placing on the market, the distribution, the
p.(None): Erection, commissioning, maintenance, operation, application, clinical evaluation and testing, monitoring and sterilization,
p.(None): Disinfection and cleaning of medical devices and their accessories as well as averting risks and quality management when dealing with
p.(None): 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, apparatus, devices, software, materials or other used individually or connected
p.(None): Items, including those specifically designed by the manufacturer for use in diagnostic or therapeutic purposes, and for being in good condition
p.(None): Functioning of the software used by the medical device, which are intended for use by humans for the following purposes:
p.(None): 1. detection, prevention, monitoring, treatment or relief of diseases,
p.(None): 2. detection, monitoring, treatment, alleviation or compensation of injuries or disabilities,
p.(None): 3. Examination, change or to replace the anatomical structure or physiological processes or
p.(None): 4. Conception regulation
p.(None): and their intended main effect in or on the human body neither by pharmacological or immunological means nor metabolically
p.(None): is achieved, but the mode of action can be supported by such means. A new, reprocessed medical device is equivalent to the new one.
p.(None): (1a) “Subcategory of medical devices” is a group of medical devices that are to be used in the same areas or with the same
p.(None): Technologies.
p.(None): (1b) “Generic product group” is a group of medical devices with the same or similar usage regulations or with technological ones
p.(None): Similarities so that they can be generally classified without taking into account specific characteristics.
p.(None): (1c) "Disposable product" is a medical device that is intended for single use by a single person.
p.(None): (2) "Accessories" for a medical device are objects, substances, preparations made of substances and software that are not themselves medical devices according to paragraph 1,
p.(None): but are intended according to their intended purpose expressly defined by the manufacturer,
p.(None): 1. to be used together with a medical device, so that it corresponds to the one specified by the manufacturer of the medical device
p.(None): Purpose of the medical device can be used, 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 implantable medical devices. Accessories for an in-
p.(None): Vitro Diagnostic is itself an In Vitro Diagnostic, unless it is an invasive product intended for taking samples as well
p.(None): Products that come into direct contact with the human body for the purpose of sampling. These are considered medical devices in the sense of
p.(None): Directive 93/42 / EEC.
p.(None): (3) "Active medical device" is any medical device, the operation of which is dependent on an electrical energy source or another energy source than
p.(None): the energy generated directly by the human body or by gravity. A medical device that is used to transmit energy, shock or
p.(None): Parameters between an active medical device and the patient is used without a significant change in energy, shock or
...
p.(None): Specify register by regulation. This regulation also includes 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 in accordance with paragraphs 1 and 2, only that is required for patient identification
p.(None): Use of the area-specific personal identifiers GH and AS (Section 10 (2) E-Government Act, Federal Law Gazette I No. 10/2004) permitted. The
p.(None): area-specific personal identifiers AS may only be used and saved in encrypted form. The direct personal reference is immediate
p.(None): irreversibly deleted after conversion.
p.(None): (6) The area-specific personal identifiers are to be deleted as soon as they are no longer required for the purposes set out in paragraph 1. The federal agency
p.(None): "Statistics Austria" has the Health Austria GmbH - upon 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 identity and role of the authorized user at every access
p.(None): be proven and logged according to the state of the art. He must ensure that the appropriate state of the art
p.(None): Appropriate precautions are taken to prevent the destruction or modification of the data by program errors (viruses) and to prevent
p.(None): Prevent destruction, modification or query of the data in the register by unauthorized users or systems. He must also ensure that
p.(None): all usage processes carried out, such as in particular entries, changes, queries and transmissions, are traceable. He has a
p.(None): To create a data security concept that is binding for the employees of Gesundheit Österreich GmbH.
p.(None): (9) The healthcare institutions participating in the registers may access data in the registers for scientific purposes in
p.(None): access pseudonymized form.
p.(None): (10) Any access to the data processed or to be processed in the registers by Gesundheit Österreich GmbH may only be made for the purposes of paragraph 1
p.(None): respectively.
p.(None): (11) The Federal Office for Safety in Health Care is authorized to access the data processed in the registers in pseudonymised form,
p.(None): if this is for the purpose of protecting the health and safety of patients, for warding off risks and for the purpose of medical device vigilance and
p.(None): Market surveillance is necessary.
p.(None): (12) The Managing Director of Gesundheit Österreich GmbH is obliged to give access to the individual users of Gesundheit Österreich
p.(None): GmbH individually assign. Health Austria GmbH's authorized users are aware of the provisions of the General Data Protection Regulation and the
p.(None): To teach data security concept. These access rights shall be withdrawn from their access rights if they are used to further fulfill them
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Health / Mentally Disabled
Searching for indicator disabled:
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p.(None): Documents are made available that provide an assessment with regard to their professional quali fi cation and experience as well as the existing facilities
p.(None): and allow the staff.
p.(None): § 58. (1) With regard to clinical trials outside of hospitals, the governor must ensure that in the area of his
p.(None): A sufficient number of independent state ethics committees are set up to perform the tasks set out in Section 60.
p.(None): (2) For the clinical examination at hospitals, the responsible ethics committee in accordance with Section 8c of the Hospitals Act, Federal Law Gazette No. 1/1957.
p.(None): (3) The appointment of ethics committees in accordance with paragraph 1 is to the Federal Ministry of Health and Women and the Federal Office for Security in the
p.(None): 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 not covered by Z 1 to 8, who is entrusted with the pastoral care or otherwise through the
p.(None): required ethical competence. Additional experts should be consulted if the assessment of a clinical trial requires it. The
p.(None): Ethics Committee has to be made up of women and men. If possible, care should be taken to ensure a balanced relationship. For each
p.(None): A representative is to be appointed. The members of the ethics committee listed in Z 1 and 2 may not at the same time clinical investigators within the scope of the
p.(None): assessing clinical trial.
p.(None): Section 59. (1) The members of the ethics committee and their deputies must be free of instructions in this function. You have any relationships with manufacturers
p.(None): or distributors of medical devices to the governor in full. They have become active in the ethics committee -
p.(None): without prejudice to any other reasons for bias - to include in all matters in which such a relationship is appropriate, their full
p.(None): To question impartiality.
p.(None): (1a) Within the framework of the organization, internal quality assurance measures are to be provided, which include in particular the regularity of the processes and
p.(None): Ensure procedures.
p.(None): (2) The implementation of the agendas of the ethics committee and the proper completion of its decisions and statements is in one
p.(None): To set down the rules of procedure in writing, which require the approval of the responsible governor.
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Searching for indicator disability:
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p.(None): BGBl. No. 155/1990, is not carried out.
p.(None): Section 52a. (1) A clinical trial of its kind can only be used in emergency situations in which, within a reasonable time, no consent of the legal representative
p.(None): can be obtained, a clinical trial can then be performed on a person who is unable to consent,
p.(None): if
p.(None): 1. There are no indications that either the patient refused or would refuse the clinical trial or that the requirements of the
p.(None): § 52 exist,
p.(None): 2. Such research for the validation of data used in clinical trials on persons capable of obtaining informed consent or by means of
p.(None): other research methods have been obtained and are essential 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 is intended to fulfill an intended purpose within the meaning of Section 2 (1) nos. 1 to 3 in an emergency situation,
p.(None): 4. The application of the medical device that is being tested, based on the knowledge of medical science, is indicated to the emergency patient
p.(None): a) to recognize, prevent, monitor, treat or alleviate an illness,
p.(None): (b) identify, monitor, treat, alleviate or compensate for an injury or disability, or
p.(None): c) to examine, change or replace the anatomical structure or physiological processes,
p.(None): and the benefit to the patient associated with inclusion in the clinical trial outweighs the risk
p.(None): 5. the conduct of the test and the test plan by an ethics committee that has knowledge in the field of the disease concerned, in relation to the
p.(None): EmergencyXsituation and the affected patient group or who are in clinical and ethical questions in the field of the disease in question
p.(None): With regard to the emergency situation and the affected patient group, advice was given, specifically for the conduct of clinical trials in emergency situations
p.(None): to persons who are unable to give their personal consent, and
p.(None): 6. In case of doubt, the patient's interests always outweigh the public and scientific interests.
p.(None): (2) The test center at which a clinical test is carried out in emergency situations on persons who are unable to give consent is the
p.(None): To inform the public about this in an appropriate manner.
p.(None): (3) If the patient gains the consent, he must be informed immediately that a clinical trial in an emergency situation is on him
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Health / Motherhood/Family
Searching for indicator family:
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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 in the Austrian healthcare system and
p.(None): 5. for scientific purposes
p.(None): To maintain implant registers for active implantable medical devices, soft tissue implants, cardiovascular, 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, specific implant parameters, data on individual implant settings, and
p.(None): 7. Technical, clinical, organizational, temporal and event-related data for aftercare.
p.(None): (3) The implanting / treating healthcare facilities are, if this is to protect the health and safety of patients
p.(None): is necessary, the personal data of Gesundheit Österreich GmbH mentioned in Paragraph 2 and required for the purposes of keeping the register
p.(None): can also be submitted online. Health Austria GmbH is responsible for granting access to health care facilities
p.(None): documented in a comprehensible manner.
p.(None): (4) The Federal Minister for Health, Family and Youth has set up implant registers and the speci fi c data sets for the individual
p.(None): Specify register by regulation. This regulation also includes 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 in accordance with paragraphs 1 and 2, only that is required for patient identification
p.(None): Use of the area-specific personal identifiers GH and AS (Section 10 (2) E-Government Act, Federal Law Gazette I No. 10/2004) permitted. The
p.(None): area-specific personal identifiers AS may only be used and saved in encrypted form. The direct personal reference is immediate
p.(None): irreversibly deleted after conversion.
p.(None): (6) The area-specific personal identifiers are to be deleted as soon as they are no longer required for the purposes set out in paragraph 1. The federal agency
p.(None): "Statistics Austria" has the Health Austria GmbH - upon 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 identity and role of the authorized user at every access
p.(None): be proven and logged according to the state of the art. He must ensure that the appropriate state of the art
p.(None): Appropriate precautions are taken to prevent the destruction or modification of the data by program errors (viruses) and to prevent
...
p.(None): Market surveillance is necessary.
p.(None): (12) The Managing Director of Gesundheit Österreich GmbH is obliged to give access to the individual users of Gesundheit Österreich
p.(None): GmbH individually assign. Health Austria GmbH's authorized users are aware of the provisions of the General Data Protection Regulation and the
p.(None): To teach data security concept. These access rights shall be withdrawn from their access rights if they are used to further fulfill them
p.(None): no longer need the assigned tasks or do not process the data in accordance with their intended purpose.
p.(None): (13) The managing director of Gesundheit Österreich GmbH has to ensure through organizational and technical precautions that access is granted
p.(None): Rooms in which the database server is located can only be accessed by those with access to Health Austria GmbH.
p.(None): (14) If the database server is removed from the area of Gesundheit Österreich GmbH, the managing director of Gesundheit Österreich GmbH
p.(None): ensure that unauthorized use is excluded.
p.(None): (15) The marketers of implants, which are kept in registers according to paragraph 1, are obliged to do what is necessary for the purposes of the register
p.(None): to provide the technical data of your implants to Gesundheit Österreich GmbH in electronic form.
p.(None): Traceability of medical devices
p.(None): Section 73b. The Federal Minister of Health, Family and Youth has, insofar as this is concerned with the protection of the health and safety of patients,
p.(None): Users or third parties and the defense against risks is required, considering types, groups or classes of medical devices with increased
p.(None): Risk potential through ordinance for the placing on the market of medical devices and those responsible for health care facilities
p.(None): To take precautions and measures with regard to the traceability of medical devices and to make stipulations about
p.(None): 1. the types, groups or classes of medical devices that are covered by the traceability requirements,
p.(None): 2. the product or product group-speci fi c requirements with regard to traceability as well as with regard to type, content, speci fi city and availability of
p.(None): records required in this regard, and
p.(None): 3. the manner in which suitable implant registers are set up in healthcare facilities and the necessary records.
p.(None): observational
p.(None): § 74. The Federal Minister of Health and Consumer Protection can consider serious interests of public health and
p.(None): with a view to gaining improved knowledge about the benefit / risk assessment of certain types or groups of medical devices, in particular
p.(None): also about the long-term effects of implantable medical devices that can only be obtained through systematic data collection and analysis
p.(None): can, by regulation, prescribe that relevant data, which have been collected in connection with the use of these medical devices and for which
...
p.(None): 3. With regard to Section 80 (2), Section 81 (1) and Section 92, insofar as electrotechnical safety, the measuring functions of
p.(None): Medical devices and commercial law provisions are concerned, and with regard to Section 99 (1), as far as commercial law concerns are concerned,
p.(None): the Federal Minister for Health and Consumer Protection in agreement with the Federal Minister for Economic Affairs and
p.(None): 4. With regard to Section 98 (1), the Federal Minister for Health and Consumer Protection in agreement with the Federal Minister for Economic Affairs
p.(None): Affairs
p.(None): entrusted.
p.(None): (2) Before enacting ordinances in accordance with this federal law, the federal ministers responsible in accordance with para
p.(None): Experts in the field of matter to be regulated in each 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 Austrian Dental Association, the Federal Chamber of Labor,
p.(None): the Austrian Chamber of Commerce, the Austrian Chamber of Pharmacists, the Main Association of Austrian Social Insurance Institutions, the
p.(None): Belong to Austrian Agency for Health and Nutritional Security GmbH, business unit PharmMed, and the Austrian Senior Council.
p.(None): Furthermore, according to the state law implementing provisions to § 11e of the Federal Law 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, Family and Youth, the activities of the advisory board are updated
p.(None): rules of procedure to be adopted by the Federal Minister for Health, Family and Youth. 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. In agreement with the chairman, the
p.(None): Consult representatives in accordance with paragraph 2 further experts.
p.(None): to the top
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Health / Physically Disabled
Searching for indicator illness:
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p.(None): on which the clinical trial is carried out, to achieve a purpose in accordance with Section 2 (1) and which includes inclusion in the clinical trial
p.(None): Exam related benefits for the test subject outweigh the risk
p.(None): 3. The consent of the legal guardian has been demonstrably and in writing given the appropriate information,
p.(None): 4. the minor, prior to the start of the clinical trial, by one of the clinical investigators experienced in dealing with minors, should be able to do so
p.(None): understand has received appropriate information,
p.(None): 5. the consent of the minor who is able to see the nature, meaning, scope and risks of the clinical trial, and
p.(None): its will to be determined according to it has been demonstrably granted, and it is ensured that the wish expressly expressed by a minor,
p.(None): not participating in the clinical trial or ending at any time is considered by the clinical investigator,
p.(None): 6. the consent can be withdrawn at any time without causing a disadvantage for the minor,
p.(None): 7. there are no incentives or financial benefits with the exception of an allowance for participation in the clinical trial,
p.(None): 8. The clinical trial is planned in such a way that it takes into account as little as possible, taking into account the illness and the stage of development of the minor
p.(None): Pain, discomfort, fear and other foreseeable risks are connected, whereby the risk threshold as well as the degree of exposure are specific
p.(None): must be defined and constantly checked,
p.(None): 9. The test plan from an ethics committee that has knowledge in the field of pediatrics and adolescent medicine or that is in clinical, ethical
p.(None): and psychosocial issues in the field of paediatrics and adolescent medicine was advised, endorsed, and
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of science.
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 a significant extension of the scientific understanding of the condition, the illness or the disorder of the minor
p.(None): aims and can thereby benefit either the patient or the patient group to which the minor belongs, and
p.(None): 2. the clinical trial brings minimal risk and burden to the minor; a clinical trial shows a minimal
p.(None): Risk and a minimal burden, if it can be expected that they lead to a minor and only temporary impairment
p.(None): and any symptoms or inconveniences may be very minor and will only occur temporarily.
p.(None): § 52. The clinical trial may be carried out on a person who is suffering from a mental illness or a comparable impairment of their
p.(None): Ability to make decisions has a legal representative or has been stopped by judicial or official order or in accordance with the Accommodation Act,
p.(None): BGBl. No. 155/1990, is not carried out.
p.(None): Section 52a. (1) A clinical trial of its kind can only be used in emergency situations in which, within a reasonable time, no consent of the legal representative
p.(None): can be obtained, a clinical trial can then be performed on a person who is unable to consent,
p.(None): if
p.(None): 1. There are no indications that either the patient refused or would refuse the clinical trial or that the requirements of the
p.(None): § 52 exist,
p.(None): 2. Such research for the validation of data used in clinical trials on persons capable of obtaining informed consent or by means of
p.(None): other research methods have been obtained and are essential 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 is intended to fulfill an intended purpose within the meaning of Section 2 (1) nos. 1 to 3 in an emergency situation,
p.(None): 4. The application of the medical device that is being tested, based on the knowledge of medical science, is indicated to the emergency patient
p.(None): a) to recognize, prevent, monitor, treat or alleviate an illness,
p.(None): (b) identify, monitor, treat, alleviate or compensate for an injury or disability, or
p.(None): c) to examine, change or replace the anatomical structure or physiological processes,
p.(None): and the benefit to the patient associated with inclusion in the clinical trial outweighs the risk
p.(None): 5. the conduct of the test and the test plan by an ethics committee that has knowledge in the field of the disease concerned, in relation to the
p.(None): EmergencyXsituation and the affected patient group or who are in clinical and ethical questions in the field of the disease in question
p.(None): With regard to the emergency situation and the affected patient group, advice was given, specifically for the conduct of clinical trials in emergency situations
p.(None): to persons who are unable to give their personal consent, and
p.(None): 6. In case of doubt, the patient's interests always outweigh the public and scientific interests.
p.(None): (2) The test center at which a clinical test is carried out in emergency situations on persons who are unable to give consent is the
p.(None): To inform the public about this in an appropriate manner.
p.(None): (3) If the patient gains the consent, he must be informed immediately that a clinical trial in an emergency situation is on him
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Searching for indicator physically:
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p.(None): Section 111a. For all personal names used in this federal law, the chosen form applies to 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 Federal Minister of Finance, may charge fees for this
p.(None): Federal acts and activities to be carried out by federal agencies, the necessity of which is derived from this federal law and the
p.(None): based on regulations or relevant legal acts of the European Union adopted in a tariff. The tariff can also
p.(None): Fees for reports in accordance with Section 67 and for reports in connection with implant registers in accordance with an ordinance in accordance with Section 73 are set.
p.(None): (2) When determining the fee-based facts, on the one hand, the experience has shown that the average costs arise, on the other hand
p.(None): to take due account of the importance or the benefit for the debtor. The tariff and its changes are in the “Official Gazette of Vienna
p.(None): Newspaper ”.
p.(None): (3) Does this result from this federal law, the regulations issued on the basis thereof or from legal acts of the European Union
p.(None): The necessity for official acts or activities of federal agencies for which a tariff has not been set are those that actually arise
p.(None): To prescribe costs.
p.(None): (4) For cash expenses, irrespective of the fees set in the tariff in accordance with Section 76 of the General Administrative Procedure Act 1991,
p.(None): 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 as physically available individual products according to the on December 31, 1994 in
p.(None): Regulations that were in force before 15 June 1998 were placed on the market in Austria, 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 the requirements according to § 8 are not met or it
p.(None): measures are taken in accordance with Section 77.
p.(None): (2) Medical devices for in vitro diagnosis, which comply with the regulations that were in force in Austria on December 7, 1998, may still be used until
p.(None): placed on the market in Austria at the end of December 6, 2003. In vitro diagnostic medical devices placed on the market in this way may be used until the end of the
p.(None): December 6, 2005 will continue to be placed on the market or put into operation in Austria, unless the requirements according to §§ 8, 9 and 11 are not
p.(None): fulfilled or measures are taken according to § 77. 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, insofar as this applies to the protection of the health and safety of patients,
p.(None): Users or third parties and the prevention of significant risks is required through regulation conformity assessment procedures for medical devices for which the
p.(None): Transitional provision of paragraph 1 applies as a prerequisite for placing on the market and commissioning and their type. Content and implementation
p.(None): to be specified.
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Health / Pregnant
Searching for indicator pregnant:
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p.(None): 6. In case of doubt, the patient's interests always outweigh the public and scientific interests.
p.(None): (2) The test center at which a clinical test is carried out in emergency situations on persons who are unable to give consent is the
p.(None): To inform the public about this in an appropriate manner.
p.(None): (3) If the patient gains the consent, he must be informed immediately that a clinical trial in an emergency situation is on him
p.(None): was or will be carried out. It must be clarified in the sense of Sections 49 and 50. 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. Further processing of the data processed up to that point requires the
p.(None): express consent under data protection law.
p.(None): (4) As soon as the consent can be obtained from the legal representative, a continuation of the clinical trial is only under the conditions
p.(None): of § 51 permitted.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, the data processed up to that point may be used for the purposes of this clinical
p.(None): Testing can be used.
p.(None): Section 53. The clinical trial of a medical device may only be carried out on a pregnant or breastfeeding mother if
p.(None): 1. the medical device to be tested to achieve a purpose according to § 2 paragraph 1 for nursing mothers, pregnant women or unborn children
p.(None): is determined
p.(None): 2. the application of the medical device according to the knowledge of medical science is indicated to the nursing mother or
p.(None): Pregnant women on whom the clinical trial is being carried out or the purpose of their unborn child in accordance with Section 2 (1),
p.(None): 3. According to the knowledge of medical science, conducting the clinical trial is not expected to pose any risks to the unborn or
p.(None): brings breastfed child with him and
p.(None): 4. According to the knowledge of the medical sciences, the clinical trial is only sufficient on pregnant women or nursing mothers
p.(None): Exam results can be expected.
p.(None): § 54. The clinical trial of a medical device may not be carried out on persons who do a presence or training or community service.
p.(None): Dealing with data
p.(None): § 55. (1) During the entire course of the clinical trial, patient-related data of all persons involved are strictly confidential
p.(None): to treat. All patient-related data must be protected against unauthorized access and, as far as possible, pseudonymized, ensuring that
p.(None): is that the additional information with which the personal data can be assigned to an affected person is kept separately
p.(None): become.
p.(None): (2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and confidential handling of all within the framework of a
p.(None): clinical trial data.
p.(None): (3) The study plan, the final report and all data and documents created in connection with the clinical study are for specific periods
p.(None): after completion or termination of the clinical trial, which the Federal Minister of Health and Consumer Protection issues in a regulation
p.(None): Section 66 are to be laid down. This regulation also specifies who is responsible for keeping certain data or documents.
p.(None): (3a) For the period of the retention periods, the right according to Art. 17 General Data Protection Regulation is excluded.
p.(None): (4) All data and documents relevant to the clinical trial must be submitted to the Federal Office for Safety in Health Care upon request
...
Health / breastfeeding
Searching for indicator breastfeeding:
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p.(None): (2) The test center at which a clinical test is carried out in emergency situations on persons who are unable to give consent is the
p.(None): To inform the public about this in an appropriate manner.
p.(None): (3) If the patient gains the consent, he must be informed immediately that a clinical trial in an emergency situation is on him
p.(None): was or will be carried out. It must be clarified in the sense of Sections 49 and 50. 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. Further processing of the data processed up to that point requires the
p.(None): express consent under data protection law.
p.(None): (4) As soon as the consent can be obtained from the legal representative, a continuation of the clinical trial is only under the conditions
p.(None): of § 51 permitted.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, the data processed up to that point may be used for the purposes of this clinical
p.(None): Testing can be used.
p.(None): Section 53. The clinical trial of a medical device may only be carried out on a pregnant or breastfeeding mother if
p.(None): 1. the medical device to be tested to achieve a purpose according to § 2 paragraph 1 for nursing mothers, pregnant women or unborn children
p.(None): is determined
p.(None): 2. the application of the medical device according to the knowledge of medical science is indicated to the nursing mother or
p.(None): Pregnant women on whom the clinical trial is being carried out or the purpose of their unborn child in accordance with Section 2 (1),
p.(None): 3. According to the knowledge of medical science, conducting the clinical trial is not expected to pose any risks to the unborn or
p.(None): brings breastfed child with him and
p.(None): 4. According to the knowledge of the medical sciences, the clinical trial is only sufficient on pregnant women or nursing mothers
p.(None): Exam results can be expected.
p.(None): § 54. The clinical trial of a medical device may not be carried out on persons who do a presence or training or community service.
p.(None): Dealing with data
p.(None): § 55. (1) During the entire course of the clinical trial, patient-related data of all persons involved are strictly confidential
...
Health / patients in emergency situations
Searching for indicator emergency situation:
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p.(None): and any symptoms or inconveniences may be very minor and will only occur temporarily.
p.(None): § 52. The clinical trial may be carried out on a person who is suffering from a mental illness or a comparable impairment of their
p.(None): Ability to make decisions has a legal representative or has been stopped by judicial or official order or in accordance with the Accommodation Act,
p.(None): BGBl. No. 155/1990, is not carried out.
p.(None): Section 52a. (1) A clinical trial of its kind can only be used in emergency situations in which, within a reasonable time, no consent of the legal representative
p.(None): can be obtained, a clinical trial can then be performed on a person who is unable to consent,
p.(None): if
p.(None): 1. There are no indications that either the patient refused or would refuse the clinical trial or that the requirements of the
p.(None): § 52 exist,
p.(None): 2. Such research for the validation of data used in clinical trials on persons capable of obtaining informed consent or by means of
p.(None): other research methods have been obtained and are essential 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 is intended to fulfill an intended purpose within the meaning of Section 2 (1) nos. 1 to 3 in an emergency situation,
p.(None): 4. The application of the medical device that is being tested, based on the knowledge of medical science, is indicated to the emergency patient
p.(None): a) to recognize, prevent, monitor, treat or alleviate an illness,
p.(None): (b) identify, monitor, treat, alleviate or compensate for an injury or disability, or
p.(None): c) to examine, change or replace the anatomical structure or physiological processes,
p.(None): and the benefit to the patient associated with inclusion in the clinical trial outweighs the risk
p.(None): 5. the conduct of the test and the test plan by an ethics committee that has knowledge in the field of the disease concerned, in relation to the
p.(None): EmergencyXsituation and the affected patient group or who are in clinical and ethical questions in the field of the disease in question
p.(None): With regard to the emergency situation and the affected patient group, advice was given, specifically for the conduct of clinical trials in emergency situations
p.(None): to persons who are unable to give their personal consent, and
p.(None): 6. In case of doubt, the patient's interests always outweigh the public and scientific interests.
p.(None): (2) The test center at which a clinical test is carried out in emergency situations on persons who are unable to give consent is the
p.(None): To inform the public about this in an appropriate manner.
p.(None): (3) If the patient gains the consent, he must be informed immediately that a clinical trial in an emergency situation is on him
p.(None): was or will be carried out. It must be clarified in the sense of Sections 49 and 50. 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. Further processing of the data processed up to that point requires the
p.(None): express consent under data protection law.
p.(None): (4) As soon as the consent can be obtained from the legal representative, a continuation of the clinical trial is only under the conditions
p.(None): of § 51 permitted.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, the data processed up to that point may be used for the purposes of this clinical
p.(None): Testing can be used.
p.(None): Section 53. The clinical trial of a medical device may only be carried out on a pregnant or breastfeeding mother if
p.(None): 1. the medical device to be tested to achieve a purpose according to § 2 paragraph 1 for nursing mothers, pregnant women or unborn children
p.(None): is determined
p.(None): 2. the application of the medical device according to the knowledge of medical science is indicated to the nursing mother or
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p.(None): (5) The Federal Minister of Health and Consumer Protection has the other contracting parties to the Agreement on the European Economic Area and
p.(None): the European Commission immediately in terms of designations in accordance with paragraph 2 and on the revocation or restriction of a designation in accordance with paragraph 4
p.(None): To put knowledge.
p.(None): Minimum criteria for notified bodies
p.(None): Section 37. (1) The notified body, its manager and the personnel responsible for carrying out the assessments and tests must be independent of the body
p.(None): be the one who developed or designed the medical device to be assessed, as well as its manufacturer, distributor, installer or user You may not
p.(None): directly as a representative for the development or construction, for the manufacture, for distribution or for the applicant for the maintenance of these
p.(None): Products to be involved. This does not make it possible to exchange technical information between the manufacturer and the notified body
p.(None): locked out.
p.(None): (2) The notified body must be able to perform all the tasks provided for in a conformity assessment procedure in accordance with an ordinance pursuant to Section 28
p.(None): be assigned to such a body and for which it is designated, be it that these tasks are performed by the notified body itself or be that it is in
p.(None): Sub-areas are carried out under their responsibility. In particular, it must have the personnel and the resources necessary to meet the requirements of the
p.(None): Carrying out the assessments and examinations associated with medical-scientific, technical and administrative tasks are required. she
p.(None): must have the equipment required for testing and monitoring, but may use external facilities in some areas if
p.(None): access to these is regulated and their suitability is ensured.
p.(None): (3) The body and the personnel commissioned with the examination must carry out the evaluations and examinations with the necessary expertise and reliability
p.(None): in the field of medical devices and 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, after establishing agreement with the client, a notified body carries out certain work in connection with the
p.(None): Conformity assessment to a subcontractor, it must first ensure that the provisions of this section are from the subcontractor
p.(None): be respected. The notified body has the relevant documents for assessing the technical competence of the subcontractor and on the latter's
p.(None): To have work carried out within the scope of this federal law available for inspection by the responsible authorities.
p.(None): (5) Parts of conformity assessment procedures to be subcontracted may only make up the smaller part of the overall order. The
p.(None): Overall responsibility for carrying out a conformity assessment procedure must be borne by the notified body.
p.(None): (6) The personnel responsible for the examinations must meet the following requirements:
p.(None): 1. the professional qualifications required for the assessments and examinations for which the position has been designated,
p.(None): 2. Adequate knowledge of the rules for the tests he has carried out and sufficient practical experience in this field, and
p.(None): 3. those for the conduct of the tests and the drafting of certificates, minutes and reports in which the tests carried out
p.(None): be laid down, required suitability.
...
p.(None): 1. the medical device to be tested to achieve a purpose according to § 2 paragraph 1 for nursing mothers, pregnant women or unborn children
p.(None): is determined
p.(None): 2. the application of the medical device according to the knowledge of medical science is indicated to the nursing mother or
p.(None): Pregnant women on whom the clinical trial is being carried out or the purpose of their unborn child in accordance with Section 2 (1),
p.(None): 3. According to the knowledge of medical science, conducting the clinical trial is not expected to pose any risks to the unborn or
p.(None): brings breastfed child with him and
p.(None): 4. According to the knowledge of the medical sciences, the clinical trial is only sufficient on pregnant women or nursing mothers
p.(None): Exam results can be expected.
p.(None): § 54. The clinical trial of a medical device may not be carried out on persons who do a presence or training or community service.
p.(None): Dealing with data
p.(None): § 55. (1) During the entire course of the clinical trial, patient-related data of all persons involved are strictly confidential
p.(None): to treat. All patient-related data must be protected against unauthorized access and, as far as possible, pseudonymized, ensuring that
p.(None): is that the additional information with which the personal data can be assigned to an affected person is kept separately
p.(None): become.
p.(None): (2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and confidential handling of all within the framework of a
p.(None): clinical trial data.
p.(None): (3) The study plan, the final report and all data and documents created in connection with the clinical study are for specific periods
p.(None): after completion or termination of the clinical trial, which the Federal Minister of Health and Consumer Protection issues in a regulation
p.(None): Section 66 are to be laid down. This regulation also specifies who is responsible for keeping certain data or documents.
p.(None): (3a) For the period of the retention periods, the right according to Art. 17 General Data Protection Regulation is excluded.
p.(None): (4) All data and documents relevant to the clinical trial must be submitted to the Federal Office for Safety in Health Care upon request
p.(None): Verification of compliance with the provisions of this federal law on clinical trials are made available.
p.(None): Quality control and quality management
p.(None): Section 56. (1) The sponsor and the clinical investigator have an adequate view of the planning, implementation and evaluation of a clinical trial
p.(None): System of quality management to apply, the complete traceability of all observations and findings, the correct collection and
p.(None): Processing of data and the correct derivation of conclusions guaranteed.
p.(None): (2) An audit initiated by the sponsor must be carried out by bodies or organizational units that are independent of those for the clinical trial
p.(None): Are responsible.
...
p.(None): Seriously increases the chances of success,
p.(None): 2. information about the medical device used and the clinical trial has been made available to the social security institution or third parties
p.(None): and
p.(None): 3. Social insurance institutions or third parties on the basis of these documents after assessing the existence of the requirements of points 1 and 2 of an application
p.(None): have agreed to the assumption of costs.
p.(None): (5) The sponsor must assess the test plan and confirm it with his signature.
p.(None): (6) The sponsor may delegate the performance of its duties or obligations in whole or in part to external scientific institutions.
p.(None): Tasks and responsibilities of the clinical investigator
p.(None): Section 64. (1) Clinical investigators may only be appropriately qualified for independent practice of the medical or dental profession in Austria
p.(None): be an authorized 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 has at least two years of experience in clinical trials
p.(None): can demonstrate.
p.(None): (2) Before the start of the clinical trial, the clinical investigator has to deal with all relevant data and documents, in particular with regard to the study plan, the
p.(None): relevant scientific literature, the preclinical data, the results of previous clinical trials with the medical device, the evidence of the
p.(None): Technical safety, the documents on the structure, composition, functionality, properties and performance of the medical device and the instructions
p.(None): to familiarize yourself thoroughly with its intended use. The sponsor has access to all relevant data to the clinical investigator
p.(None): guarantee.
p.(None): (3) The clinical investigator must ensure that he and his staff also consider the personnel and the available
p.(None): Institutions and medical facilities 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 information and, if necessary, their information required by this federal law
p.(None): legal representative and obtaining the necessary consent.
p.(None): (4a) The clinical investigator has to fulfill the obligations for the sponsor according to Art. 13, 15, 16 and 18 of the General Data Protection Regulation and in the event of violations of the
p.(None): Protection of personal data to notify the test participant in accordance with Art. 34 of the General Data Protection Regulation and to the sponsor
p.(None): inform.
p.(None): (5) The clinical investigator has the sponsor about all medical device side effects and all serious adverse events within the scope of the
p.(None): clinical trial.
p.(None): (6) The clinical investigator must sign the study plan and confirm in writing and with his signature that he has completed the clinical study in accordance with the
p.(None): Test plan and the provisions of this federal law.
p.(None): (7) The clinical investigator has all employees who are involved in the conduct of the clinical trial or in the supervision of the trial participants,
...
p.(None): Report. When designating the medical devices in the regulation according to paragraph 7, there is a significant risk potential for these medical devices and that
p.(None): Need to be promptly informed of these facilities in the cases of Section 77 and 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 parties to the Agreement about the European
p.(None): Economic area and the European Commission on their request and by means of a common European data network on the
p.(None): Reports according to paragraphs 1, 2 and 5.
p.(None): (7) The Federal Minister of Health can take into account the uniformity of the reports and the one for medical device monitoring
p.(None): stipulate the required information by ordinance Art. Content, 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 the directive 93/42 / EEC and for in-vitro diagnostics of Annex II and in-vitro diagnostics
p.(None): The Federal Minister of Health may notify the Federal Minister of Health of all information that identifies the medical device in order to apply Directive 98/79 / EC
p.(None): enable and determine the labeling and instructions for use if these medical devices are in operation within the scope of this federal law
p.(None): be taken. The Federal Minister of Health can also use this ordinance with regard to reporting requirements, modalities and access authorizations
p.(None): commit to the European database as defined by Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC.
p.(None): Section 2
p.(None): monitoring
p.(None): Section 68. (1) Companies, facilities or persons who deal with medical devices professionally or commercially, in particular manufacture medical devices,
p.(None): Check, store, transport, pack, exhibit, place on the market or assemble the medical devices professionally or within the meaning of Section 33 (1)
p.(None): Maintain, convert, assemble, adapt or process commercially, clean, disinfect or professionally or professionally clean medical devices
p.(None): sterilize or use or operate the medical devices in healthcare facilities are subject to the following with regard to these activities
p.(None): Monitoring.
p.(None): (2) Monitoring within the meaning of paragraph 1 is carried out by the organs of the Federal Office for Safety in Health Care, the Federal Minister for
p.(None): Health and women or by experts commissioned by them. The activity of relevant accredited bodies, from
p.(None): Federal Minister of Health and Women recognized organizer of proficiency tests, operators of medical device registers or other organizers
p.(None): supra-regional comparative tests and assessments in connection with medical devices recognized by the Federal Minister of Health and Women
p.(None): be included.
p.(None): (3) Insofar as monitoring is provided within the scope of conformity assessment procedures in accordance with an ordinance pursuant to Section 28, this is carried out by
p.(None): the relevant notified body responsible for the conformity assessment procedure. Monitoring by notified bodies is carried out in accordance with a regulation
p.(None): § 28.
...
p.(None): Implantations of pacemakers, implantable defibrillators and loop recorders,
p.(None): 2. for the purpose of medical device vigilance and market surveillance in connection with pacemakers, implantable defibrillators and loop devices
p.(None): recorders,
p.(None): 3. for the purpose of quality-assured treatment in connection with the corresponding implantations,
p.(None): 4. for the purpose of quality assurance of pacemakers, implantable defibrillators and loop recorders,
p.(None): 5. for the purpose of statistics as a basis for planning, quality assurance and quality reporting in the Austrian healthcare system and
p.(None): 6. for scientific purposes
p.(None): maintain a register for pacemakers, implantable defibrillators and loop recorders. Gesundheit Österreich GmbH is responsible for the
p.(None): 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 implanting / treating facility or name of the
p.(None): treating doctor, hospital number, contact details),
p.(None): 2. Data on patient identification (name, gender, date of birth, social security number, contact details, area-speci fi c
p.(None): Personal identifiers)
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 (pre-intervention, symptoms, etiology, preoperative heart rhythm),
p.(None): 5. Technical, clinical, organizational and temporal data on the care process (surgeon, implantation data of the medical devices and the
p.(None): associated probes, date of implantation, location of medical devices, access, secondary prophylaxis),
p.(None): 6. Technical data on the implant, speci fi c implant parameters, data on the individual implant setting (model, manufacturer and serial number of the
p.(None): Medical devices and the associated probes, implant parameters), and
p.(None): 7. Technical, clinical, organizational, temporal and event-related data for aftercare (technical and clinical control data of the implanted
p.(None): Medical devices and the associated probes, functional status, date and indication of the control, complications, explant date,
p.(None): Explantationsgrund).
p.(None): (3) The implanting / treating health facilities are obliged in accordance with paragraph 4, the data types mentioned in paragraph 2 of the
p.(None): Gesundheit Österreich GmbH to be transmitted personally online.
p.(None): (4) The transmission according to paragraph 3 is only permitted if the data subjects
p.(None): 1. have been informed about the processing for the purposes of the pacemaker, ICD or loop recorder register and
p.(None): 2. have expressly consented to this processing.
p.(None): If the consent is withdrawn in the event of a follow-up contact, the person concerned must be informed that the data is directly related to a person
p.(None): irreversibly deleted and the remaining data, due to a lack of assignability, can no longer be used for your treatment purposes. Does it exist
p.(None): affected person even after being informed about these consequences on the revocation of their consent, Gesundheit Österreich GmbH is entitled to the revocation
p.(None): inform. Gesundheit Österreich GmbH has to pseudonymize the data immediately.
p.(None): (4a) Insofar as no consent has been given, the implanting or treating 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 nos. 5 and 6.
p.(None): (5) The granting of access authorizations to the pacemaker, ICD and loop recorder register by health care institutions
p.(None): clearly documented by Gesundheit Österreich GmbH. When granting access authorizations by institutions of the
p.(None): Health care must ensure that access rights are only granted to the extent that this is specifically necessary for a purpose in accordance with paragraph 1
p.(None): is. The granting of access authorization has to refer to specific persons, their clear identity and scope of the authorization of health
p.(None): Österreich GmbH must be proven.
p.(None): (6) When processing data in accordance with paragraphs 1 and 2, the use of the name and the area-speci fi c is for patient identification
p.(None): Personal identification number GH and AS (Section 10 Paragraph 2 E Government Act, Federal Law Gazette I No. 10/2004) permitted. The area-specific personal identifier AS may only be in
p.(None): encrypted form can be used and saved. The person responsible must delete the direct personal link irreversibly as soon as it is for
p.(None): the purposes according to paragraph 1 nos. 1 and 3 are no longer necessary.
p.(None): (7) Gesundheit Österreich GmbH is entitled to obtain information on the time and cause of death from
p.(None): To request persons whose data are processed in the register.
p.(None): (8) The managing director of Gesundheit Österreich GmbH has to ensure that the identity and role of those authorized to access the state of health at every access
p.(None): Technically proven and logged accordingly. He must ensure that the appropriate state-of-the-art technology is used
p.(None): Precautions are taken to prevent the destruction or modification of the data due to program errors (viruses), to prevent destruction,
p.(None): Prevent unauthorized users or systems from changing or querying the data in the register. Furthermore, he must ensure that everyone
p.(None): processing operations carried out, such as entries, changes, queries and transmissions in particular, are traceable. He has a
p.(None): To create a data security concept that is binding for the employees of Gesundheit Österreich GmbH.
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 access the data processed or processed in the register
p.(None): 1. basically only in pseudonymized form,
p.(None): 2. to exercise the rights of data subjects in accordance with Chapter 3 of the General Data Protection Regulation, but also in a directly personal form
p.(None): access. For scientific purposes, Gesundheit Österreich GmbH may only access in a pseudonymized form.
p.(None): (12) The health care institutions participating in the registers may
p.(None): 1. For the purposes of paragraph 1 no. 3, access all data relating to this person in the register, also in personal form, if this is within the scope
p.(None): a specific treatment situation of the respective person is required,
p.(None): a) with the express consent of the data subject, or
p.(None): (b) where consent cannot be obtained, in the vital interest of the data subject, and
p.(None): 2. access the data processed in the register in pseudonymized form for scientific purposes (para. 1 no. 6).
p.(None): (13) For purposes of medical device vigilance, the Federal Office for Safety in Health Care is entitled to access the data processed in the register
p.(None): access personal form, provided this is in individual cases 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 is for the purposes of medical device vigilance and market surveillance and for purposes
p.(None): the quality assurance of medical devices is 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 give access to the individual users of Gesundheit Österreich
p.(None): GmbH individually assign. Health Austria GmbH's authorized users are aware of the provisions of the General Data Protection Regulation and the
p.(None): To teach data security concept. These access rights shall be withdrawn from their access rights if they are used to further fulfill them
p.(None): no longer need the assigned tasks or do not process the data in accordance with their intended purpose.
p.(None): (15) The managing director of Gesundheit Österreich GmbH must ensure through organizational and technical precautions that access is granted
p.(None): Rooms in which the database server is located can only be accessed by those with access to Health Austria GmbH.
p.(None): (16) If the database server is removed from the area of Gesundheit Österreich GmbH, the managing director of Gesundheit Österreich GmbH
p.(None): ensure that unauthorized use is excluded.
p.(None): (17) The distributors of medical devices, which are kept in the pacemaker, ICD, loop recorder register, are required for purposes
p.(None): to make the necessary technical data of your implants available 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 to ward off the risks of implantable
p.(None): Medical devices,
p.(None): 2. for the purpose of medical device vigilance and market surveillance of implantable 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 in the Austrian healthcare system and
p.(None): 5. for scientific purposes
p.(None): To maintain implant registers for active implantable medical devices, soft tissue implants, cardiovascular, 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, specific implant parameters, data on individual implant settings, and
p.(None): 7. Technical, clinical, organizational, temporal and event-related data for aftercare.
p.(None): (3) The implanting / treating healthcare facilities are, if this is to protect the health and safety of patients
p.(None): is necessary, the personal data of Gesundheit Österreich GmbH mentioned in Paragraph 2 and required for the purposes of keeping the register
p.(None): can also be submitted online. Health Austria GmbH is responsible for granting access to health care facilities
p.(None): documented in a comprehensible manner.
p.(None): (4) The Federal Minister for Health, Family and Youth has set up implant registers and the speci fi c data sets for the individual
p.(None): Specify register by regulation. This regulation also includes 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 in accordance with paragraphs 1 and 2, only that is required for patient identification
p.(None): Use of the area-specific personal identifiers GH and AS (Section 10 (2) E-Government Act, Federal Law Gazette I No. 10/2004) permitted. The
p.(None): area-specific personal identifiers AS may only be used and saved in encrypted form. The direct personal reference is immediate
p.(None): irreversibly deleted after conversion.
p.(None): (6) The area-specific personal identifiers are to be deleted as soon as they are no longer required for the purposes set out in paragraph 1. The federal agency
p.(None): "Statistics Austria" has the Health Austria GmbH - upon 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 identity and role of the authorized user at every access
p.(None): be proven and logged according to the state of the art. He must ensure that the appropriate state of the art
p.(None): Appropriate precautions are taken to prevent the destruction or modification of the data by program errors (viruses) and to prevent
p.(None): Prevent destruction, modification or query of the data in the register by unauthorized users or systems. He must also ensure that
p.(None): all usage processes carried out, such as in particular entries, changes, queries and transmissions, are traceable. He has a
p.(None): To create a data security concept that is binding for the employees of Gesundheit Österreich GmbH.
p.(None): (9) The healthcare institutions participating in the registers may access data in the registers for scientific purposes in
p.(None): access pseudonymized form.
p.(None): (10) Any access to the data processed or to be processed in the registers by Gesundheit Österreich GmbH may only be made for the purposes of paragraph 1
p.(None): respectively.
p.(None): (11) The Federal Office for Safety in Health Care is authorized to access the data processed in the registers in pseudonymised form,
p.(None): if this is for the purpose of protecting the health and safety of patients, for warding off risks and for the purpose of medical device vigilance and
p.(None): Market surveillance is necessary.
p.(None): (12) The Managing Director of Gesundheit Österreich GmbH is obliged to give access to the individual users of Gesundheit Österreich
p.(None): GmbH individually assign. Health Austria GmbH's authorized users are aware of the provisions of the General Data Protection Regulation and the
p.(None): To teach data security concept. These access rights shall be withdrawn from their access rights if they are used to further fulfill them
p.(None): no longer need the assigned tasks or do not process the data in accordance with their intended purpose.
p.(None): (13) The managing director of Gesundheit Österreich GmbH has to ensure through organizational and technical precautions that access is granted
p.(None): Rooms in which the database server is located can only be accessed by those with access to Health Austria GmbH.
p.(None): (14) If the database server is removed from the area of Gesundheit Österreich GmbH, the managing director of Gesundheit Österreich GmbH
p.(None): ensure that unauthorized use is excluded.
p.(None): (15) The marketers of implants, which are kept in registers according to paragraph 1, are obliged to do what is necessary for the purposes of the register
p.(None): to provide the technical data of your implants to Gesundheit Österreich GmbH in electronic form.
p.(None): Traceability of medical devices
p.(None): Section 73b. The Federal Minister of Health, Family and Youth has, insofar as this is concerned with the protection of the health and safety of patients,
p.(None): Users or third parties and the defense against risks is required, considering types, groups or classes of medical devices with increased
p.(None): Risk potential through ordinance for the placing on the market of medical devices and those responsible for health care facilities
p.(None): To take precautions and measures with regard to the traceability of medical devices and to make stipulations about
p.(None): 1. the types, groups or classes of medical devices that are covered by the traceability requirements,
p.(None): 2. the product or product group-speci fi c requirements with regard to traceability as well as with regard to type, content, speci fi city and availability of
p.(None): records required in this regard, and
p.(None): 3. the manner in which suitable implant registers are set up in healthcare facilities and the necessary records.
p.(None): observational
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p.(None): express consent under data protection law.
p.(None): (4) As soon as the consent can be obtained from the legal representative, a continuation of the clinical trial is only under the conditions
p.(None): of § 51 permitted.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, the data processed up to that point may be used for the purposes of this clinical
p.(None): Testing can be used.
p.(None): Section 53. The clinical trial of a medical device may only be carried out on a pregnant or breastfeeding mother if
p.(None): 1. the medical device to be tested to achieve a purpose according to § 2 paragraph 1 for nursing mothers, pregnant women or unborn children
p.(None): is determined
p.(None): 2. the application of the medical device according to the knowledge of medical science is indicated to the nursing mother or
p.(None): Pregnant women on whom the clinical trial is being carried out or the purpose of their unborn child in accordance with Section 2 (1),
p.(None): 3. According to the knowledge of medical science, conducting the clinical trial is not expected to pose any risks to the unborn or
p.(None): brings breastfed child with him and
p.(None): 4. According to the knowledge of the medical sciences, the clinical trial is only sufficient on pregnant women or nursing mothers
p.(None): Exam results can be expected.
p.(None): § 54. The clinical trial of a medical device may not be carried out on persons who do a presence or training or community service.
p.(None): Dealing with data
p.(None): § 55. (1) During the entire course of the clinical trial, patient-related data of all persons involved are strictly confidential
p.(None): to treat. All patient-related data must be protected against unauthorized access and, as far as possible, pseudonymized, ensuring that
p.(None): is that the additional information with which the personal data can be assigned to an affected person is kept separately
p.(None): become.
p.(None): (2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and confidential handling of all within the framework of a
p.(None): clinical trial data.
p.(None): (3) The study plan, the final report and all data and documents created in connection with the clinical study are for specific periods
p.(None): after completion or termination of the clinical trial, which the Federal Minister of Health and Consumer Protection issues in a regulation
p.(None): Section 66 are to be laid down. This regulation also specifies who is responsible for keeping certain data or documents.
p.(None): (3a) For the period of the retention periods, the right according to Art. 17 General Data Protection Regulation is excluded.
...
Searching for indicator children:
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p.(None): was or will be carried out. It must be clarified in the sense of Sections 49 and 50. 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. Further processing of the data processed up to that point requires the
p.(None): express consent under data protection law.
p.(None): (4) As soon as the consent can be obtained from the legal representative, a continuation of the clinical trial is only under the conditions
p.(None): of § 51 permitted.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, the data processed up to that point may be used for the purposes of this clinical
p.(None): Testing can be used.
p.(None): Section 53. The clinical trial of a medical device may only be carried out on a pregnant or breastfeeding mother if
p.(None): 1. the medical device to be tested to achieve a purpose according to § 2 paragraph 1 for nursing mothers, pregnant women or unborn children
p.(None): is determined
p.(None): 2. the application of the medical device according to the knowledge of medical science is indicated to the nursing mother or
p.(None): Pregnant women on whom the clinical trial is being carried out or the purpose of their unborn child in accordance with Section 2 (1),
p.(None): 3. According to the knowledge of medical science, conducting the clinical trial is not expected to pose any risks to the unborn or
p.(None): brings breastfed child with him and
p.(None): 4. According to the knowledge of the medical sciences, the clinical trial is only sufficient on pregnant women or nursing mothers
p.(None): Exam results can be expected.
p.(None): § 54. The clinical trial of a medical device may not be carried out on persons who do a presence or training or community service.
p.(None): Dealing with data
p.(None): § 55. (1) During the entire course of the clinical trial, patient-related data of all persons involved are strictly confidential
p.(None): to treat. All patient-related data must be protected against unauthorized access and, as far as possible, pseudonymized, ensuring that
p.(None): is that the additional information with which the personal data can be assigned to an affected person is kept separately
p.(None): become.
...
p.(None): 3. to deceive about the product characteristics defined in the basic requirements within the meaning of §§ 8, 9 and a regulation according to § 10
p.(None): Appropriate names, information or designs 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 based on the type and form of the announcement or the placing on the market
p.(None): are capable of falsely raising the expectation of the user that these objects are themselves medical devices or have a medical device
p.(None): corresponding mechanism of action.
p.(None): § 103. Information on the intended purpose in advertising materials must not contradict the labeling and instructions for use and no information
p.(None): regarding an additional purpose.
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 to be used by healthcare professionals on or for the patient, or
p.(None): 3. Medical devices, their use by consumers based on the instructions for use only in connection with a medical or dental
p.(None): Treatment or monitoring may take place,
p.(None): operate.
p.(None): Section 105. Medical device advertising intended for consumers must be designed in such a way that the advertising character is clearly expressed and that
p.(None): 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 or is superior to another treatment or another medical device,
p.(None): 2. are intended exclusively or mainly for children,
p.(None): 3. make medical treatment seem superfluous, in particular because it can lead to a false self-diagnosis, or one
p.(None): Recommend treatment by correspondence,
p.(None): 4. relate to certificates of recovery in an abusive, worrying or misleading manner,
p.(None): 5. Abusive, worrying or misleading visual representations of changes in the human body due to
p.(None): Use diseases, injuries or disabilities or the effect of a medical device on or in the human body.
p.(None): Section 107. (1) Medical device advertising intended for consumers must contain at least the following information:
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 can also cause undesirable effects or if its use is special
p.(None): Safety precautions are required.
p.(None): (2) Medical device advertising intended for consumers must, if applicable, contain a note that the instructions for use are accurate
p.(None): Observe and, if necessary, the advice of a doctor, dentist, dentist, pharmacist or any other person based on their professional training
p.(None): authorized person. If advertising takes place via acoustic or audiovisual media, this notice must be clearly audible.
p.(None): professional advertising
p.(None): Section 108. In the context of sales promotion for medical devices among the persons to whom prescription, dispensing, procurement for facilities
p.(None): healthcare, construction, commissioning or application tasks, it is prohibited to give them a premium, fi nancial or material benefit
p.(None): to grant, offer or promise unless they are of little value and of importance for medical or medical technology practice. The
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.(None): Raw data was reported and evaluated correctly and the clinical trial was conducted in accordance with the study plan. An audit must either
p.(None): by an internal sponsor unit that operates independently of the unit responsible for clinical research, or by an external unit
p.(None): scientific institution.
p.(None): (14) "Inspection of a clinical trial" is carried out by the responsible ethics committee, the Federal Office for Safety in Health Care
p.(None): this commissioned expert or a check carried out by a foreign health authority at the test center or at the sponsor who
p.(None): Compliance with the provisions of this federal law or other regulations on the clinical trial of medical devices checked.
p.(None): (14a) "Inspection of a performance assessment test" is one commissioned by the Federal Office for Safety in Health Care
p.(None): Experts or by a foreign health authority review of a performance assessment test that compliance
p.(None): Regulations of this federal law or other regulations on the performance evaluation of in vitro diagnostics checked.
p.(None): (15) “Adverse event” means any adverse clinical event in a subject included in a clinical trial, independent
p.(None): whether it is related to the tested or performance-rated medical device or not.
p.(None): (16) An event or a side effect within the meaning of Section 2 (17) that is fatal or life-threatening is to be classified as serious
p.(None): Causes damage or requires inpatient treatment or an extension of the inpatient stay. Any undesirable event or any
p.(None): Medical device side effect that causes damage to a fetus, its death or a congenital malformation, or the appearance of a malignant
p.(None): In any case, tumors are classified as serious.
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 deciding whether a product is under the
p.(None): AMG or falls under this federal law, in particular due to the main mode of operation of the product,
p.(None): 2. cosmetic products within the meaning of § 5 of the Food Act 1975, Federal Law Gazette № 86, (note: from 21.1.2006: food safety and
p.(None): Consumer Protection Act - LMSVG, Federal Law Gazette I No. 13/2006)
p.(None): 3. human blood, blood products, blood plasma or blood cells of human origin or products at the time of placing on the market
p.(None): Contain blood products, blood plasma or blood cells of this type, with the exception of in vitro diagnostics and medical devices within the meaning of Section 2 (5c),
p.(None): 4. Organs, tissues or cells of human origin as well as products containing or from tissues or cells of human origin
p.(None): Tissues or cells have been obtained, unless 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 using killed animal tissue or
p.(None): manufactured from killed products derived from animal tissue or in vitro diagnostic medical devices,
p.(None): 6. Natural healing deposits and products from a natural healing deposit within the meaning of Section 42a (2) of the Federal Act on Hospitals and
p.(None): Kuranstalten, BGBl. No. 1/1957.
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Social / Incarcerated
Searching for indicator restricted:
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p.(None): 2. Adequate knowledge of the rules for the tests he has carried out and sufficient practical experience in this field, and
p.(None): 3. those for the conduct of the tests and the drafting of certificates, minutes and reports in which the tests carried out
p.(None): be laid down, required suitability.
p.(None): (7) The independence of the personnel commissioned with the examination must be ensured. The amount of the remuneration of each auditor may not vary according to the number of
p.(None): the tests he carries out are still based on the results of these tests
p.(None): (8) The notified body must take out sufficient liability insurance for liability cases that may arise from its activities, unless
p.(None): this liability is covered by the Republic of Austria.
p.(None): (9) The notified body has
p.(None): 1. the Federal Ministry of Health on all certificates issued, changed, supplemented, suspended, revoked or refused, and
p.(None): 2. the other bodies designated under Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC about all suspended, revoked or refused
p.(None): Certificates as well as certificates issued on request
p.(None): to inform. The notified body must also provide all relevant additional information on request.
p.(None): (10) If a notified body ascertains that relevant requirements of this Federal Act have not been met or are no longer met by the manufacturer
p.(None): , or a certificate should not have been issued, it sets the - taking into account the principle of proportionality
p.(None): issued or revoked the certificate or imposed restrictions, unless the manufacturer guarantees the remedial measures through suitable remedial measures
p.(None): Compliance with these requirements. The notified body will inform the Federal Ministry of Labor, Health and Social Affairs if the certificates
p.(None): suspended, revoked or restricted or intervention by the Federal Minister of Labor, Health and Social Affairs proves to be necessary
p.(None): could.
p.(None): (11) The notified body has all relevant information and documents, including the budgetary documents for a
p.(None): Provide verification of compliance with the rules for notified bodies.
p.(None): (12) By ordinance, the Federal Minister of Health can impose uniform requirements with regard to designation, monitoring and activities
p.(None): 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 and those set out in sections 1 and 3 of Annex I to Directive 93/42 / EEC
p.(None): mentioned characteristics and performance relevant requirements of a medical device under normal conditions of use, as well as the assessment of
p.(None): undesirable side effects and the acceptability of the benefit / risk ratio as indicated in Section 5 of Annex I to Directive 90/385 / EEC or in
p.(None): Section 6 of Annex I to Directive 93/42 / EEC must always be based on clinical data.
p.(None): (2) The evaluation of this clinical data, hereinafter referred to as "clinical evaluation", in the case of relevant harmonized standards
p.(None): must be taken into account, must be carried out according to a defined and methodically flawless procedure based on a critical assessment
p.(None): 1. the available relevant scientific literature on safety, performance, design features and purpose of the medical device,
p.(None): in which
p.(None): (a) the conformity of the medical device with the medical device to which the data relate must be demonstrated; and
p.(None): (b) the data are reasonably capable of demonstrating compliance with the relevant essential requirements; or
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Social / Laboratory Staff
Searching for indicator research staff:
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p.(None): inform. The reporting requirements of § 70 remain unaffected.
p.(None): Tasks and areas of responsibility of the people involved in the clinical trial
p.(None): Section 62. (1) The responsibilities and duties of the persons involved in the clinical trial, in particular the sponsor, clinical investigator
p.(None): and monitors must be specified in writing and confirmed by their signatures.
p.(None): (2) The sponsor may assume the function of the sponsor and that of the monitor by the sponsor if this is documented
p.(None): and the respective responsibilities and areas of responsibility are fully assumed.
p.(None): Tasks and areas of responsibility of the sponsor
p.(None): § 63. (1) The sponsor has the clinical investigator taking into account his professional quali fi cation, his availability over the entire period of the
p.(None): Study and taking into account the suitability and availability of the local, medical and medical devices available to the clinical investigator
p.(None): organizational circumstances and options.
p.(None): (2) If necessary, the sponsor must ensure appropriate monitoring of the clinical trial. He has one or more accordingly
p.(None): entrust trained and quali fi ed persons with the function of a monitor in accordance with Section 65 or their areas of responsibility and responsibilities themselves
p.(None): perceive. He must also ensure that internal audits of the study can be carried out if necessary.
p.(None): (3) The sponsor has the clinical investigator all for the safe use of the medical device to be tested and the proper implementation of the
p.(None): clinical trial documentation, including relevant information that becomes available only during the ongoing study
p.(None): to provide him with administrative support, if necessary to provide supportive research staff and if necessary for a suitable one
p.(None): Training of the clinical investigator and his employees in the intended and safe installation, preparation and use of the medical device and
p.(None): of its necessary accessories.
p.(None): (4) The sponsor has to ensure that neither the test participant nor the Austrian social insurance institutions or third parties from the
p.(None): Provision of the medical device intended for clinical testing incurs costs, unless
p.(None): 1. the use of which is associated with a primary individual benefit insofar as it serves to ward off health damage or to remedy one
p.(None): physical suffering is urgently needed and an essential one compared to available medical devices that are already permitted on the market
p.(None): Seriously increases the chances of success,
p.(None): 2. information about the medical device used and the clinical trial has been made available to the social security institution or third parties
p.(None): and
p.(None): 3. Social insurance institutions or third parties on the basis of these documents after assessing the existence of the requirements of points 1 and 2 of an application
p.(None): have agreed to the assumption of costs.
p.(None): (5) The sponsor must assess the test plan and confirm it with his signature.
p.(None): (6) The sponsor may delegate the performance of its duties or obligations in whole or in part to external scientific institutions.
p.(None): Tasks and responsibilities of the clinical investigator
p.(None): Section 64. (1) Clinical investigators may only be appropriately qualified for independent practice of the medical or dental profession in Austria
p.(None): be an authorized doctor or dentist who
p.(None): 1. is trained and experienced in the area of application of the medical device to be tested and
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Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): Commercial packaging must be specified. If individual packaging is not possible, the information must appear on the accompanying information. The Federal Minister
p.(None): for work, health and social issues can be found in the regulation pursuant to § 10 in accordance with Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC with regard to the
p.(None): Practicability and adequacy of the attachment or provision of this information and to ensure the safe use of
p.(None): Provide exceptions for medical devices.
p.(None): (3) Each medical device must be accompanied by instructions for use in its packaging. Instructions for use are for medical devices
p.(None): Class I and Class IIa within the meaning of Directive 93/42 / EEC or for in vitro diagnostics within the meaning of Directive 98/79 / EC in duly justified cases
p.(None): not necessary if the correct and safe use of the medical device is guaranteed without instructions for use.
p.(None): (4) The labeling of medical devices and, in accordance with paragraph 3, their instructions for use must include the name or company name and address of the
p.(None): Manufacturer.
p.(None): (5) Provided that medical devices are imported into the scope of the Agreement on the European Economic Area to be put into circulation there for the first time
p.(None): to be brought, the label, if necessary the outer packaging or the instructions for use, also the name or the
p.(None): The company and the address of the person responsible for the first placing on the market, in the case of in-vitro diagnostics of the authorized representative, if not included
p.(None): is identical to the manufacturer.
p.(None): (6) Medical devices may only be given to the user or consumer if the information intended for him or the patient is given in
p.(None): German language are written. The Federal Minister of Health and Consumer Protection can by ordinance taking into account a sufficient
p.(None): Information for patients and users and taking into account the guarantee of medical device safety exceptions to the requirement of
p.(None): Allow German language or provisions on the admissibility of other suitable measures than the package leaflet for informing the user
p.(None): Provide users or patients.
p.(None): § 10. The Federal Minister of Health and Women has with regard to ensuring the medical performance of medical devices according to § 2
p.(None): and with regard to the protection of the health and safety of patients, users and, where appropriate, third parties and the prevention of risks by regulation
p.(None): 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 only be placed on the market, erected, without prejudice to Sections 6 to 9 and a regulation pursuant to Section 10
p.(None): Operated and used if the requirements in accordance with paragraph 2 and a regulation in accordance with paragraph 3 are also met.
p.(None): (2) Medical devices for in vitro diagnosis must be designed and manufactured in such a way that they take into account the generally recognized state of the art
p.(None): Technology is suitable for the purpose specified by the manufacturer in accordance with Section 2 (5). You need the performance parameters, especially with regard to
p.(None): the sensitivity, specificity, precision, accuracy, reproducibility and detection limits specified by the manufacturer correspond. The traceability of the
p.(None): The values ascribed to the calibration substances or devices or control materials must be determined by available higher-level reference measurement methods and
p.(None): Reference materials can be guaranteed.
...
p.(None): Users and third parties or the prevention of significant risks is required by regulation conformity assessment procedures for medical devices for in-vitro
p.(None): Prescribe diagnosis as a prerequisite for placing on the market and commissioning and specify its type. Content and implementation.
p.(None): Section 29. (1) Sets the conformity assessment procedure in accordance with an ordinance in accordance with Section 28 (1) or the procedure in accordance with Sections 33 to 35
p.(None): Involvement of a notified body, the manufacturer or his authorized representative can contact a body designated for the performance of these tasks
p.(None): Turn choice. The simultaneous referral of several notified bodies as part of a conformity assessment procedure for a medical device by the
p.(None): Manufacturer or his authorized representative is not permitted.
p.(None): (2) In the conformity assessment procedures for a medical device, the manufacturer or the notified body has the results of assessments and
p.(None): Consider tests, which may be in an intermediate stage of manufacture in accordance with this federal law or other Austrian
p.(None): Regulations within the meaning of Section 112 (1) and (2) have been made.
p.(None): (3) At the reasoned request, all information or details relating to the exhibition are to be submitted to or made available to the notified body
p.(None): the certificate of conformity and maintenance of the conformity decision with regard to the selected procedure are required.
p.(None): (4) The documents and correspondence regarding the procedures for conformity assessment are provided that they are within the scope of this Federal Act
p.(None): be carried out in German 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 authorized representative established in the European Economic Area must do so before the first
p.(None): Issue the declaration provided for in a regulation pursuant to Section 28 and make the documentation listed there available. From the
p.(None): Documentation must include the design, manufacture and performance data of the medical device including the intended performance in the manner
p.(None): show that it enables an assessment to be made as to whether the requirements of this federal law have been met.
p.(None): (2) The manufacturer must take all necessary measures to ensure that the medical device manufactured complies with the
p.(None): Documentation is ensured in accordance with a regulation according to § 28. 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 a notification of all custom-made products in accordance with Directive 93/42 / EEC
p.(None): claims that have been put into operation or placed on the market within the scope of this federal law.
p.(None): Section 5
p.(None): Exhibit; Exemptions in the interest of health protection; Systems and treatment centers; Sterilization for that
p.(None): marketing
p.(None): Exhibit
p.(None): Section 31. (1) Medical devices that do not comply with sections 15 and 27 may then be used for demonstration purposes, especially at trade fairs, exhibitions,
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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 averting risks and quality management when dealing with
p.(None): 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, apparatus, devices, software, materials or other used individually or connected
p.(None): Items, including those specifically designed by the manufacturer for use in diagnostic or therapeutic purposes, and for being in good condition
p.(None): Functioning of the software used by the medical device, which are intended for use by humans for the following purposes:
p.(None): 1. detection, prevention, monitoring, treatment or relief of diseases,
p.(None): 2. detection, monitoring, treatment, alleviation or compensation of injuries or disabilities,
p.(None): 3. Examination, change or to replace the anatomical structure or physiological processes or
p.(None): 4. Conception regulation
p.(None): and their intended main effect in or on the human body neither by pharmacological or immunological means nor metabolically
p.(None): is achieved, but the mode of action can be supported by such means. A new, reprocessed medical device is equivalent to the new one.
p.(None): (1a) “Subcategory of medical devices” is a group of medical devices that are to be used in the same areas or with the same
p.(None): Technologies.
p.(None): (1b) “Generic product group” is a group of medical devices with the same or similar usage regulations or with technological ones
p.(None): Similarities so that they can be generally classified without taking into account specific characteristics.
p.(None): (1c) "Disposable product" is a medical device that is intended for single use by a single person.
p.(None): (2) "Accessories" for a medical device are objects, substances, preparations made of substances and software that are not themselves medical devices according to paragraph 1,
p.(None): but are intended according to their intended purpose expressly defined by the manufacturer,
p.(None): 1. to be used together with a medical device, so that it corresponds to the one specified by the manufacturer of the medical device
p.(None): Purpose of the medical device can be used, 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 implantable medical devices. Accessories for an in-
p.(None): Vitro Diagnostic is itself an In Vitro Diagnostic, unless it is an invasive product intended for taking samples as well
p.(None): Products that come into direct contact with the human body for the purpose of sampling. These are considered medical devices in the sense of
p.(None): Directive 93/42 / EEC.
p.(None): (3) "Active medical device" is any medical device, the operation of which is dependent on an electrical energy source or another energy source than
p.(None): the energy generated directly by the human body or by gravity. A medical device that is used to transmit energy, shock or
p.(None): Parameters between an active medical device and the patient is used without a significant change in energy, shock or
p.(None): Parameters does not count as an active medical device.
p.(None): (4) “Active implantable medical device” is any medical device that operates on an electrical energy source or an energy source other than that
p.(None): is directly dependent on the energy generated by the human body or gravity, and is designed to be wholly or partly by one
...
p.(None): and are intended for exclusive use in a named patient. Standard-made medical devices that are adapted
p.(None): to meet the speci fi c requirements of the doctor or other licensed user authorized to do so are not considered to be
p.(None): Custom made.
p.(None): (7) "Manufacturer" is any natural or legal person who is responsible for the design, manufacture, packaging and labeling of a medical device in the
p.(None): Responsible for the first placing on the market in your own name. 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 assembles, packs, treats, processes or prepares one or more prefabricated products
p.(None): indicates or is responsible for determining the intended use as a medical device with a view to placing it on the market in its own name.
p.(None): However, the manufacturer is not who - without being a manufacturer within the meaning of paragraph 7 - already placed products on the market for a named patient
p.(None): assembled or adapted according to its purpose.
p.(None): (8a) “Authorized representative” is the natural or legal person established in the European Economic Area (EEA), who is expressly authorized by the manufacturer
p.(None): was determined to act on his behalf with regard to his obligations under this federal law and that of the authorities and
p.(None): To be contacted in this sense in the EEA. If a manufacturer that markets a medical device in its own name does not have a seat in one
p.(None): Contracting party to the EEA, he must have a single authorized representative in the EEA in writing for at least all medical devices of the same model
p.(None): to name.
p.(None): (9) “Intended use” is the use for which the medical device is labeled according to the manufacturer's instructions and instructions for use
p.(None): or the advertising material is intended.
p.(None): (10) "Placing on the market" is the return of a medical device for or against payment or the readiness for the delivery. Placing on the market
p.(None): not before if
p.(None): 1. it is a medical device exclusively intended for clinical testing within the meaning of section 3 (3) or an in vitro diagnostic medical device for
p.(None): Performance evaluation purposes within the meaning of Section 3 (3a),
p.(None): 2. it is ensured by suitable measures that the medical device cannot reach the consumer, user or operator, or
p.(None): 3. Individual medical devices to a single specific person only free of charge and in the private sphere or in neighborhood help
p.(None): be passed on.
p.(None): (11) "First placing on the market" is the first placing on the market of a medical device or the first placing on the market of a medical device after it
p.(None): Reprocessing with a view to its distribution or 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): who places a medical device on the market for the first time within the scope of the Agreement on the European Economic Area and within the scope of the
p.(None): Agreement on the European Economic Area is established.
p.(None): (13) "Commissioning" is the phase in which a medical device is made available to the end user as a product that is first called
p.(None): ready-to-use medical device can be used in accordance with its intended use within the scope of the European Economic Area. at
p.(None): Active implantable medical devices are considered to be commissioning when they are made available to medical personnel for implantation.
p.(None): (14) “Exhibiting” is the setting up or demonstration of medical devices for the purpose of advertising or informing specialist circles.
p.(None): (15) "Harmonized standards" are national standards of the contracting states to the Agreement on the European Economic Area, the relevant ones
p.(None): carry out harmonized European standards, their references as "harmonized standards" for medical devices in the Official Journal of the European Communities
p.(None): have been published. Relevant monographs of the European Pharmacopoeia for Medical Devices, whose
...
p.(None): Sponsor to assume additional responsibility if he has a clinical trial regardless of the manufacturer of the medical device and in full
p.(None): Carries out personal responsibility.
p.(None): (6) “Monitor” is a person designated by the sponsor who is responsible for monitoring and reporting on the progress of the clinical trial
p.(None): Exam is responsible.
p.(None): (7) “Clinical trial plan” or “protocol” is a document that provides detailed information on the reasons, intentions, goals, execution and intended
p.(None): Contains analyzes, methodology and conduct of the clinical trial.
p.(None): (7a) "Evaluation plan" is a document that provides detailed information about a planned performance assessment test, particularly with regard to the
p.(None): scientific, technical and medical justification, the goals, the methodology, the intended analysis and sampling, the test
p.(None): Contains performance criteria and requirements as well as the type and scope of the intended evaluation.
p.(None): (8) "Subject" is either a patient or a healthy subject who is taking a clinical trial or a performance assessment exam
p.(None): In vitro diagnostic agent participates.
p.(None): (9) “Ethics Committee” is an independent body composed of medical experts and others in accordance with Section 58 (4)
p.(None): Members whose job it is to assess whether there is a scientifically sound clinical trial and whether the safety of that
p.(None): Wellbeing, the rights and integrity of test takers are protected.
p.(None): (10) "Final report of the clinical trial" or "Final report" is a complete description and evaluation of the clinical trial after its
p.(None): Termination.
p.(None): (11) “Multi-center trial” is a clinical trial that follows a single clinical trial schedule but at multiple sites
p.(None): is carried out.
p.(None): (12) “Case report scheme” or “test sheet” is a set of documents that are designed so that all relevant patient and medical device related
p.(None): Data that are required by the clinical trial plan are fully documented.
p.(None): (13) "Audit" is the comparison of the raw data and the related records with the interim or final report to determine whether the
p.(None): Raw data was reported and evaluated correctly and the clinical trial was conducted in accordance with the study plan. An audit must either
p.(None): by an internal sponsor unit that operates independently of the unit responsible for clinical research, or by an external unit
p.(None): scientific institution.
p.(None): (14) "Inspection of a clinical trial" is carried out by the responsible ethics committee, the Federal Office for Safety in Health Care
p.(None): this commissioned expert or a check carried out by a foreign health authority at the test center or at the sponsor who
p.(None): Compliance with the provisions of this federal law or other regulations on the clinical trial of medical devices checked.
p.(None): (14a) "Inspection of a performance assessment test" is one commissioned by the Federal Office for Safety in Health Care
p.(None): Experts or by a foreign health authority review of a performance assessment test that compliance
p.(None): Regulations of this federal law or other regulations on the performance evaluation of in vitro diagnostics checked.
p.(None): (15) “Adverse event” means any adverse clinical event in a subject included in a clinical trial, independent
p.(None): whether it is related to the tested or performance-rated medical device or not.
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Social / Mothers
Searching for indicator mothers:
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p.(None): To inform the public about this in an appropriate manner.
p.(None): (3) If the patient gains the consent, he must be informed immediately that a clinical trial in an emergency situation is on him
p.(None): was or will be carried out. It must be clarified in the sense of Sections 49 and 50. 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. Further processing of the data processed up to that point requires the
p.(None): express consent under data protection law.
p.(None): (4) As soon as the consent can be obtained from the legal representative, a continuation of the clinical trial is only under the conditions
p.(None): of § 51 permitted.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, the data processed up to that point may be used for the purposes of this clinical
p.(None): Testing can be used.
p.(None): Section 53. The clinical trial of a medical device may only be carried out on a pregnant or breastfeeding mother if
p.(None): 1. the medical device to be tested to achieve a purpose according to § 2 paragraph 1 for nursing mothers, pregnant women or unborn children
p.(None): is determined
p.(None): 2. the application of the medical device according to the knowledge of medical science is indicated to the nursing mother or
p.(None): Pregnant women on whom the clinical trial is being carried out or the purpose of their unborn child in accordance with Section 2 (1),
p.(None): 3. According to the knowledge of medical science, conducting the clinical trial is not expected to pose any risks to the unborn or
p.(None): brings breastfed child with him and
p.(None): 4. According to the knowledge of the medical sciences, the clinical trial is only sufficient on pregnant women or nursing mothers
p.(None): Exam results can be expected.
p.(None): § 54. The clinical trial of a medical device may not be carried out on persons who do a presence or training or community service.
p.(None): Dealing with data
p.(None): § 55. (1) During the entire course of the clinical trial, patient-related data of all persons involved are strictly confidential
p.(None): to treat. All patient-related data must be protected against unauthorized access and, as far as possible, pseudonymized, ensuring that
p.(None): is that the additional information with which the personal data can be assigned to an affected person is kept separately
p.(None): become.
p.(None): (2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and confidential handling of all within the framework of a
p.(None): clinical trial data.
p.(None): (3) The study plan, the final report and all data and documents created in connection with the clinical study are for specific periods
p.(None): after completion or termination of the clinical trial, which the Federal Minister of Health and Consumer Protection issues in a regulation
p.(None): Section 66 are to be laid down. This regulation also specifies who is responsible for keeping certain data or documents.
p.(None): (3a) For the period of the retention periods, the right according to Art. 17 General Data Protection Regulation is excluded.
p.(None): (4) All data and documents relevant to the clinical trial must be submitted to the Federal Office for Safety in Health Care upon request
p.(None): Verification of compliance with the provisions of this federal law on clinical trials are made available.
p.(None): Quality control and quality management
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Social / Occupation
Searching for indicator job:
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p.(None): Exam participant is responsible.
p.(None): (5) "Sponsor" is any natural or legal person who is responsible for the planning, initiation, implementation and financing of a
p.(None): clinical trial takes over. The sponsor must be established in a contracting party to the EEA. The clinical investigator has the duties and the
p.(None): Sponsor to assume additional responsibility if he has a clinical trial regardless of the manufacturer of the medical device and in full
p.(None): Carries out personal responsibility.
p.(None): (6) “Monitor” is a person designated by the sponsor who is responsible for monitoring and reporting on the progress of the clinical trial
p.(None): Exam is responsible.
p.(None): (7) “Clinical trial plan” or “protocol” is a document that provides detailed information on the reasons, intentions, goals, execution and intended
p.(None): Contains analyzes, methodology and conduct of the clinical trial.
p.(None): (7a) "Evaluation plan" is a document that provides detailed information about a planned performance assessment test, particularly with regard to the
p.(None): scientific, technical and medical justification, the goals, the methodology, the intended analysis and sampling, the test
p.(None): Contains performance criteria and requirements as well as the type and scope of the intended evaluation.
p.(None): (8) "Subject" is either a patient or a healthy subject who is taking a clinical trial or a performance assessment exam
p.(None): In vitro diagnostic agent participates.
p.(None): (9) “Ethics Committee” is an independent body composed of medical experts and others in accordance with Section 58 (4)
p.(None): Members whose job it is to assess whether there is a scientifically sound clinical trial and whether the safety of that
p.(None): Wellbeing, the rights and integrity of test takers are protected.
p.(None): (10) "Final report of the clinical trial" or "Final report" is a complete description and evaluation of the clinical trial after its
p.(None): Termination.
p.(None): (11) “Multi-center trial” is a clinical trial that follows a single clinical trial schedule but at multiple sites
p.(None): is carried out.
p.(None): (12) “Case report scheme” or “test sheet” is a set of documents that are designed so that all relevant patient and medical device related
p.(None): Data that are required by the clinical trial plan are fully documented.
p.(None): (13) "Audit" is the comparison of the raw data and the related records with the interim or final report to determine whether the
p.(None): Raw data was reported and evaluated correctly and the clinical trial was conducted in accordance with the study plan. An audit must either
p.(None): by an internal sponsor unit that operates independently of the unit responsible for clinical research, or by an external unit
p.(None): scientific institution.
p.(None): (14) "Inspection of a clinical trial" is carried out by the responsible ethics committee, the Federal Office for Safety in Health Care
p.(None): this commissioned expert or a check carried out by a foreign health authority at the test center or at the sponsor who
p.(None): Compliance with the provisions of this federal law or other regulations on the clinical trial of medical devices checked.
p.(None): (14a) "Inspection of a performance assessment test" is one commissioned by the Federal Office for Safety in Health Care
...
p.(None): to be appointed as a safety officer for medical devices.
p.(None): (2) The safety officer for medical devices has to collect, assess and disclose reports about risks associated with medical devices
p.(None): coordinate necessary measures in accordance with § 72. 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 can, insofar as this is in view of the guarantee of medical device safety and the
p.(None): Defense against risks appears necessary, by regulation more detailed provisions on 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 commission persons such as those within the scope of the
p.(None): Seek professional practice in order to provide them with technical information on the respective medical devices and in the proper handling of the medical devices
p.(None): instruct those who have the required medical and medical technology expertise (medical device consultant).
p.(None): (2) The manufacturer or a person or body commissioned by him must regularly train the medical device consultants. The manufacturer has the Federal Office
p.(None): for safety in the health care system, upon request to prove the expertise of its medical device consultants.
p.(None): (3) A job as a medical device consultant may only be carried out by anyone who fulfills the requirements set out in paragraph 1 and in a regulation in accordance with paragraph 5.
p.(None): (4) The medical device consultant has messages from members of the specialist circles about side effects, mutual influences, malfunctions,
p.(None): Record technical defects, contraindications, falsifications or other risks in medical devices in writing and to the person who, in accordance with paragraph 1
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 can, insofar as this is with regard to the correct information of the user or their
p.(None): Instruction in proper handling appears necessary, taking into account the requirements of certain medical device areas or certain
p.(None): Establish trade levels by ordinance to specify requirements for the expertise of medical device consultants.
p.(None): V. MAIN PIECE
p.(None): Section 1
p.(None): Regulations for the erection, operation, use and maintenance of medical devices in and outside of facilities of the
p.(None): health
p.(None): General requirements
p.(None): Section 80. (1) Healthcare facilities must ensure that
p.(None): 1.Medical devices only in accordance with their intended purpose, in accordance with the provisions of this Federal Act or those adopted on the basis thereof
p.(None): Regulations, the generally recognized rules of technology as well as the occupational safety and accident prevention regulations are established, operated and applied
p.(None): and be maintained
p.(None): 2. Medical devices for joint use with other medical devices, with accessories, with software or with other objects only then
...
Social / Police Officer
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p.(None): Declare ethics committee sufficient. In this case, the assessing ethics committee must also announce all involved auditors and all
p.(None): Documents are made available that provide an assessment with regard to their professional quali fi cation and experience as well as the existing facilities
p.(None): and allow the staff.
p.(None): § 58. (1) With regard to clinical trials outside of hospitals, the governor must ensure that in the area of his
p.(None): A sufficient number of independent state ethics committees are set up to perform the tasks set out in Section 60.
p.(None): (2) For the clinical examination at hospitals, the responsible ethics committee in accordance with Section 8c of the Hospitals Act, Federal Law Gazette No. 1/1957.
p.(None): (3) The appointment of ethics committees in accordance with paragraph 1 is to the Federal Ministry of Health and Women and the Federal Office for Security in the
p.(None): 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 not covered by Z 1 to 8, who is entrusted with the pastoral care or otherwise through the
p.(None): required ethical competence. Additional experts should be consulted if the assessment of a clinical trial requires it. The
p.(None): Ethics Committee has to be made up of women and men. If possible, care should be taken to ensure a balanced relationship. For each
p.(None): A representative is to be appointed. The members of the ethics committee listed in Z 1 and 2 may not at the same time clinical investigators within the scope of the
p.(None): assessing clinical trial.
p.(None): Section 59. (1) The members of the ethics committee and their deputies must be free of instructions in this function. You have any relationships with manufacturers
p.(None): or distributors of medical devices to the governor in full. They have become active in the ethics committee -
p.(None): without prejudice to any other reasons for bias - to include in all matters in which such a relationship is appropriate, their full
p.(None): To question impartiality.
p.(None): (1a) Within the framework of the organization, internal quality assurance measures are to be provided, which include in particular the regularity of the processes and
p.(None): Ensure procedures.
p.(None): (2) The implementation of the agendas of the ethics committee and the proper completion of its decisions and statements is in one
...
p.(None): Federal Minister of Health and Consumer Protection on this subject to the Commission of the European Union and the other contracting parties to the agreement
p.(None): to inform the European Economic Area.
p.(None): (2a) Measures in accordance with paragraph 1 may also include medical devices whose release by the customs authorities in accordance with Article 27 paragraph 3 of the
p.(None): Regulation (EC) № 765/2008 has been suspended. In this case, the products in question are in temporary storage in accordance with Article 50 of the Regulation
p.(None): (EEC) No 2913/92 of the Council of 12 October 1992 establishing the Community Customs Code, OJ. 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 preventing the harmful effects of types of medical devices
p.(None): or groups or to protect patients, users or third parties by ordinance if this is for reasons of
p.(None): Health protection, medical device safety or in the interest of public health, and the Commission and the others
p.(None): Contracting parties to the European Economic Area to be informed accordingly. The Federal Minister of Health has also required by ordinance
p.(None): accompanying provisions, in particular regarding the determination of enforcement responsibilities, with regard to relevant regulations of the European Union
p.(None): adopted.
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 within the scope of the European Economic Area and
p.(None): has its seat in the area of application of this federal law, has a person with the expertise and reliability necessary for the performance of his work
p.(None): to be appointed as a safety officer for medical devices.
p.(None): (2) The safety officer for medical devices has to collect, assess and disclose reports about risks associated with medical devices
p.(None): coordinate necessary measures in accordance with § 72. 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 can, insofar as this is in view of the guarantee of medical device safety and the
p.(None): Defense against risks appears necessary, by regulation more detailed provisions on 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 commission persons such as those within the scope of the
p.(None): Seek professional practice in order to provide them with technical information on the respective medical devices and in the proper handling of the medical devices
p.(None): instruct those who have the required medical and medical technology expertise (medical device consultant).
p.(None): (2) The manufacturer or a person or body commissioned by him must regularly train the medical device consultants. The manufacturer has the Federal Office
p.(None): for safety in the health care system, upon request to prove the expertise of its medical device consultants.
p.(None): (3) A job as a medical device consultant may only be carried out by anyone who fulfills the requirements set out in paragraph 1 and in a regulation in accordance with paragraph 5.
p.(None): (4) The medical device consultant has messages from members of the specialist circles about side effects, mutual influences, malfunctions,
p.(None): Record technical defects, contraindications, falsifications or other risks in medical devices in writing and to the person who, in accordance with paragraph 1
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 can, insofar as this is with regard to the correct information of the user or their
p.(None): Instruction in proper handling appears necessary, taking into account the requirements of certain medical device areas or certain
p.(None): Establish trade levels by ordinance to specify requirements for the expertise of medical device consultants.
p.(None): V. MAIN PIECE
p.(None): Section 1
p.(None): Regulations for the erection, operation, use and maintenance of medical devices in and outside of facilities of the
p.(None): health
p.(None): General requirements
p.(None): Section 80. (1) Healthcare facilities must ensure that
p.(None): 1.Medical devices only in accordance with their intended purpose, in accordance with the provisions of this Federal Act or those adopted on the basis thereof
p.(None): Regulations, the generally recognized rules of technology as well as the occupational safety and accident prevention regulations are established, operated and applied
p.(None): and be maintained
p.(None): 2. Medical devices for joint use with other medical devices, with accessories, with software or with other objects only then
p.(None): be connected if this connection is harmless with regard to medical safety and functionality,
p.(None): 3. Medical devices are only used by people who, based on their training, their other knowledge or on the basis of their
p.(None): practical experience and, if necessary, product- or product-group-specific instruction guarantee the correct handling
p.(None): Offer; the instructions for use and the other enclosed safety-related information of the products involved must be observed,
p.(None): 4. Before each use of a medical device, the user should check the functionality, operational safety and the proper condition of the
...
p.(None): 11. Provides medical devices within the meaning of section 33 (1) or section 34 with an additional CE marking contrary to section 35 (1) or the declarations
p.(None): according to §§ 33 and 34 does not have ready according to § 35 paragraph 2,
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 medical device, sections 38 to 65 or a regulation
p.(None): violates § 66,
p.(None): 13a. violates § 65a or a regulation according to § 66 in the performance evaluation test of an in vitro diagnostic medical device,
p.(None): 14. does not meet the reporting requirements of Section 67,
p.(None): 15. in the case of measures to monitor its obligation to tolerate or support these measures in accordance with section 22 (2) or section 68 (8) or section 69
p.(None): Paragraph 3 does 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. does not take precautions and measures within the meaning of an ordinance in accordance with § 73 or not in accordance with § 73 or a regulation in accordance with § 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 requirements relating to the requirements of Directive 90/385 / EEC or
p.(None): 93/42 / EEC of the Council laid down requirements for active implantable medical devices manufactured using tissue of animal origin
p.(None): Contravenes devices and medical devices,
p.(None): 20. Contrary to Section 78, does not appoint a security officer or a security officer who is not Section 78 or a regulation pursuant to Section 78
p.(None): 3 corresponds to
p.(None): 21. as a security officer does not meet his obligations under Section 78,
p.(None): 22.People commissioned to perform activities in accordance with Section 79 (1) without fulfilling the requirement,
p.(None): 23. performs the activity of a medical device consultant contrary to Section 79 or a regulation pursuant to Section 79 (5)
p.(None): 24. does not comply with the general requirements of section 80 or a regulation pursuant to section 80 (2),
p.(None): 25. does not meet the requirements of section 81 or a regulation pursuant to section 81 (1) for commissioning,
p.(None): 26. does not instruct or have personnel instructed in accordance with Section 83 and does not document the instruction in accordance with Section 83 (3),
p.(None): 27. contrary to § 84 does not keep an inventory or does not keep the inventory according to § 84,
p.(None): 28. does not meet its maintenance obligations in accordance with Section 85,
p.(None): 29. does not conduct the examinations in accordance with sections 86 to 88 or a regulation in accordance with section 92 or uses persons for this purpose who do not comply with section 90 (1)
p.(None): correspond,
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 sterilizes a medical device contrary to § 93 or a regulation according to § 94,
p.(None): 34. does not take the precautions and measures for quality management in accordance with an ordinance pursuant to Section 95 (1),
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, does not have the minimum equipment available in accordance with an ordinance pursuant to Section 97,
...
Social / Property Ownership
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p.(None): Home Contact Sitemap Imprint Deutsch
p.(None): [Federal law] State law Municipal law Judiciary Other announcements, decrees Total query
p.(None): Federal law consolidated: Entire legal provision for the Medical Devices Act, version dated 01.02.2020 print view
p.(None): Other formats:
p.(None): long Title
p.(None): Federal Act on Medical Devices (Medical Devices Act - MPG)
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, 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): surgical or other medical intervention in the human body or by a medical intervention in a natural body opening
p.(None): and is intended to remain there after the procedure.
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): used for the in vitro examination of samples from the human body, including blood and tissue donations, and
p.(None): 2. serves solely or predominantly to
p.(None): (a) provide information about physiological or pathological conditions or congenital anomalies, 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, which are specifically designed for in-vitro analysis from the manufacturer by the manufacturer are also considered to be in-vitro diagnostics
p.(None): human body samples are intended as a primary container for storage. Products for general laboratory needs are not considered
p.(None): Vitro diagnostics, unless, due to their characteristics, they are intended for in vitro investigations in accordance with their intended purpose specified by the manufacturer
p.(None): to use the Z 2.
p.(None): (5a) "In vitro diagnostic medical device for personal use" is any in vitro diagnostic medical device that is designed according to the intended purpose of the layperson in the
p.(None): home environment can be applied.
p.(None): (5b) "Calibration and control material" are substances, materials and objects that are used by their manufacturer to compare measurement data or for testing
p.(None): the performance features of an in vitro diagnostic medical device are intended for the application for which it is intended.
p.(None): (5c) "Medical device with a derivative of human blood" is a medical device in accordance with Directive 90/385 / EEC or Directive 93/42 / EEC that
p.(None): as a component contains a substance that - used separately - as a pharmaceutical component or medicinal product from human blood or blood plasma in the sense of the
p.(None): Art. 1 point 10 of Directive 2001/83 / EC can be considered and in addition to the medical device can have an effect on the human body.
p.(None): The substance is referred to below as the “human blood derivative”.
p.(None): (6) “Custom-made products” are all medical devices, with the exception of in vitro diagnostic medical devices, which are prescribed by a doctor or someone else
p.(None): Because of their professional qualifications, the person authorized to do so under their responsibility is specially made according to specific design features
p.(None): and are intended for exclusive use in a named patient. Standard-made medical devices that are adapted
p.(None): to meet the speci fi c requirements of the doctor or other licensed user authorized to do so are not considered to be
p.(None): Custom made.
p.(None): (7) "Manufacturer" is any natural or legal person who is responsible for the design, manufacture, packaging and labeling of a medical device in the
p.(None): Responsible for the first placing on the market in your own name. This applies regardless of whether these activities are carried out by this person or
...
p.(None): Section 84. (1) Healthcare facilities have a medical device that is designated for this in an ordinance pursuant to Section 92
p.(None): To keep inventory.
p.(None): (2) The inventory in the sense of paragraph 1 is to be drawn up in such a way that it can be determined immediately whether and, if so, where medical devices which
p.(None): are affected by measures in accordance with section 77, are operated in this health care facility.
p.(None): Maintenance of medical devices
p.(None): Section 85. (1) Medical devices are comprehensible and professional, taking into account the manufacturer's information through inspection, maintenance and repair
p.(None): to be maintained in such a way that the functionality and safety of patients, users and third parties is guaranteed over their service life.
p.(None): (2) Inspection, maintenance and repair as well as all related tests may only be transferred to persons or bodies who, on the basis of their
p.(None): technical training and their experience gained through practical work as well as their knowledge, especially with regard to the relevant
p.(None): Legislation and standards are able to take and assess the measures required for this, as well as the possible effects and
p.(None): Recognize dangers and carry out their work properly. They must carry out and evaluate the exams in their professional
p.(None): Assessment must be free of instructions.
p.(None): (3) Healthcare facilities must take all necessary precautions for the proper maintenance of medical devices.
p.(None): (4) Provided that the corresponding types, groups or classes of medical devices are listed in an ordinance pursuant to Section 92
p.(None): 1. the providers of social insurance as well as medical and / or accident care for medical devices, which the insured / insured depend on
p.(None): Are made available for treatment in a home environment or for personal use or as part of insurance
p.(None): / Utilities are at least partially reimbursed in costs, and
p.(None): 2. Institutions that use life-saving or other health-relevant medical devices in their or in a public area for use
p.(None): keep ready,
p.(None): to take the necessary precautions for their proper maintenance. The Federal Minister of Health and Women made the determination
p.(None): of these medical devices in a regulation in accordance with Section 92 each on significant risks to the health and safety of patients and on
p.(None): Take into account any deterioration in the performance of these medical devices that would be expected in the absence of proper maintenance. In the
p.(None): Ordinance according to § 92 may also have special requirements with regard to the proper preparation and use of these medical devices and
p.(None): regarding the required training measures.
p.(None): § 86. After the repair of medical devices, the essential structural and functional requirements for safety and functionality
p.(None): Features are checked as far as they can be affected by the repair.
p.(None): Recurring safety-related tests of medical devices
p.(None): Section 87. Health care institutions must ensure that medical devices listed in an ordinance pursuant to Section 92 are of an appropriate type
p.(None): technically suitable person or position are checked regularly.
p.(None): § 88. (1) The tests in accordance with § 87 have considering the type of the medical device to be tested and the information of the manufacturer in one
p.(None): The scope is sufficient to be able to assess the safety and functional condition of the medical device. Accessories or
...
Social / Soldier
Searching for indicator army:
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p.(None): (16) "Notified Body" is one of a Contracting Party to the Agreement on the European Economic Area, the European Commission and
p.(None): the other contracting parties for the performance of tasks in the context of conformity assessment procedures for medical devices.
p.(None): (17) “Side effects” are those that occur and are related to the intended use of a medical device
p.(None): undesirable side effects.
p.(None): (18) "Mutual influence" means the effects of when used as intended
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 to preserve and restore the intended
p.(None): Target state as well as for determining and assessing the 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 assess the current state.
p.(None): (21) "Maintenance" of a medical device is the entirety of all measures to maintain the desired state, the perfect safety
p.(None): and functionality of the medical device is guaranteed.
p.(None): (22) "Repair" of a medical device are the measures for restoring the specified target state, which is the perfect safety and
p.(None): Functionality of the medical device guaranteed.
p.(None): (23) "Healthcare institution" means any institution, body or institution in which medical devices are made by health professionals or to them
p.(None): authorized business professionals are professionally operated or used, including those facilities of the Federal Army that provide medical supplies
p.(None): serve.
p.(None): Definitions for the clinical evaluation and testing of medical devices as well as for the performance evaluation 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 Annex 7 № 1.1 of the Council Directive 90/385 / EEC
p.(None): of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ. EG № L 189 of July 20, 1990,
p.(None): and Annex X No. 1.1 of Council Directive 93/42 / EEC of June 14, 1993 on 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 vitro diagnostics, on test participants with which
p.(None): Aim,
p.(None): 1. to determine the performance data of the medical device or to check whether the performance of the medical device under normal conditions of use
p.(None): performance data provided by the manufacturer or other sponsor,
p.(None): 2. Determine any side effects that occur under normal conditions of use, in terms of type, severity and frequency, with a view to determining whether these are listed under
p.(None): Taking reasonable risks into account, 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 medical laboratories or other suitable
p.(None): Organize samples from subjects, 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 in vitro diagnostic medical device is normal
...
p.(None): (9) The activity in the delimitation and classification advisory board is voluntary, without prejudice to paragraph 10. Any travel expenses are the members of the
p.(None): Delimitation and classification advisory board, its deputies and experts involved according to the highest fee level of the 1955 travel fee regulation,
p.(None): Federal Law Gazette No. 133, to be replaced on request.
p.(None): (10) The members of the Delimitation and Classification Advisory Board, which are created by the Federal Office for Safety in Health Care with the creation of
p.(None): relevant appraisals are due, due to the effort and the amount of time appropriate compensation, which the applicant
p.(None): has to carry.
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 erect, to install, to put them into operation or to use them if
p.(None): 1. there is reasonable suspicion that they meet the basic requirements within the meaning of sections 8 and 9 and a regulation according to section 10 or if applicable
p.(None): do 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 put into operation in healthcare facilities in accordance with Section 112,
p.(None): if the person responsible for the initial placing on the market is based in a contracting party to the Agreement on the European Economic Area.
p.(None): (2) The provisions of Section 6 (2) and (1) do not apply to the Federal Army when deployed in accordance with Section 2 (1) lit. a of the Wehrgesetzes 2001, Federal Law Gazette I № 146,
p.(None): as well as in the immediate preparation of this mission.
p.(None): basic requirements
p.(None): § 8. (1) Medical devices must be designed and manufactured in such a way that their use does not affect the clinical condition or the safety of the patient
p.(None): endangers the safety of users or third parties if they are used under the intended conditions and for the intended purposes. any
p.(None): Risks and side effects that can occur with the intended installation, implantation or application must be taken into account
p.(None): Effectiveness of medical devices according to the state of the medical sciences and technology to be justifiable and protection of health and safety
p.(None): must be guaranteed.
p.(None): (2) Medical devices must be designed, manufactured and packaged in such a way that they are suitable for the medical services specified by the manufacturer
p.(None): according to § 2 paragraph 1 or 5, if they are exposed to loads that are normal and under the conditions provided by the manufacturer
p.(None): Transport and storage conditions can occur.
p.(None): (3) The design and construction of medical devices must take into account the generally recognized state of science and technology
p.(None): according to the principles of integrated security. When choosing the most appropriate solutions for design and construction are given in the
p.(None): Order to apply the following principles:
p.(None): 1. Elimination or minimization of risks by integrating the safety concept into the development and construction of the medical device,
p.(None): 2. if necessary, taking appropriate protection and alarm devices against risks that cannot be eliminated from the design point of view,
...
p.(None): Medical devices may only be placed on the market and put into operation for the first time if their compliance with this federal law has been established.
p.(None): The necessary precautions to protect people must be taken during demonstrations.
p.(None): (2) When issuing in vitro diagnostic medical devices, it must also be ensured that these products are not used by participants or in any other way
p.(None): Samples taken during the exhibition can 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 may, upon request, place the product on the market and the
p.(None): Commissioning of individual medical devices, for which the conformity assessment procedure according to a regulation according to § 28 was 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 sufficient care in the ordinance pursuant to Section 28, taking into account
p.(None): with safe and efficient medical devices 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 detailed conditions under which the exemption according to paragraph 1 can be granted and also therein
p.(None): To regulate the type and content of the applications and 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 in the immediate preparation of this mission is for the
p.(None): Placing on the market and putting individual medical devices required for this case into use does not require an exemption according to paragraph 1.
p.(None): (4) An exemption within the meaning of paragraph 1 is not required if a doctor authorized to practice his or her profession independently in Austria
p.(None): confirms that a medical device is intended to avert a life threatening or a serious impairment of the patient
p.(None): Health is required and the success of treatment with a medical device, on which the procedures according to §§ 15 and 27 have already been carried out,
p.(None): probably cannot be achieved.
p.(None): Systems and treatment centers; Sterilization for placing on the market
p.(None): § 33. (1) Any natural or legal person, each with a CE-marked medical device in accordance with Directive 93/42 / EEC
p.(None): their intended purpose and within the application restrictions laid down by the manufacturer to form them in the form of a system or a
p.(None): Placing the treatment center on the market for the first time must provide an explanation of the content that:
p.(None): 1. They checked the mutual compatibility of the medical devices according to the instructions of the manufacturers and the work steps according to the
p.(None): Carried out notices,
p.(None): 2. It packs the system or the treatment center and pertinent user instructions, including the relevant instructions from the manufacturer,
p.(None): gave 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 that do not have a CE marking within the meaning of this
...
Social / Threat of Stigma
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p.(None): 9. Measures for quality management in the manufacture and other handling of 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 the operational processes relevant for medical devices.
p.(None): (3) In a regulation according to paragraph 1 it should also be provided that certain companies manufacture and store and trade in medical devices
p.(None): may only begin if they have obtained approval from the Federal Office for Safety in Health Care. It can be provided
p.(None): that the authorization is only required for the trade or wholesale of certain types or groups of medical devices. In a regulation according to
p.(None): Paragraph 1 are also the prerequisites for the approval, insofar as this includes the safety, quality and functionality of the medical devices and the safety
p.(None): and the health of patients, users or third parties. It is based on expertise, reliability and organizational
p.(None): Take special care to ensure the requirements for ensuring medical device safety.
p.(None): (4) If the Federal Office for Safety in Health Care determines that in companies within the meaning of paragraph 1 that of a regulation in accordance with paragraph 2 in each case
p.(None): specified requirements are not complied with and this results in a not inconsiderable risk to the health and safety of patients and users
p.(None): or a third party grows up, the Federal Office for Safety in Health Care can close the business, unless other measures are sufficient
p.(None): can be found. If the violation of the requirements laid down in a regulation in accordance with paragraph 2 leads to an immediate threat to the
p.(None): Health, these measures can also be taken without a previous procedure. However, this is reasoned within four weeks
p.(None): To issue notice.
p.(None): (5) The regulations in paragraphs 1 to 4 also apply to persons who professionally perform the activities listed in paragraph 1.
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, taking into account the protection of the safety and health of patients,
p.(None): Users or third parties, to ensure the required quality of medical devices and taking into account the requirements for delivery,
p.(None): in particular with regard to information, instruction, installation or functional testing as well as with regard to suitable precautions to avert risks in the
p.(None): Agreement with the Federal Minister of Economic Affairs by ordinance to stipulate that certain types of medical devices should be used only
p.(None): certain businesses or pharmacies may be sold or that a person is available to dispense the medical device
p.(None): whose training and practical experience is determined by this regulation. 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 can also determine that certain types of
p.(None): Medical devices may not be dispensed by self-service, by vending machines or by mail order.
p.(None): (2) The Federal Minister of Health and Consumer Protection has for medical devices, their installation, commissioning, operation, use or use
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Social / Trade Union Membership
Searching for indicator union:
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p.(None): 1. Type, design and implementation of the conformity assessment procedures including the respective declarations of conformity and the
p.(None): Conditions for affixing the CE marking,
p.(None): 2. the assignment of the conformity assessment procedures to the individual classes of medical devices,
p.(None): 3. Which conformity assessment procedures are to be carried out by a notified body and which are to be carried out by the manufacturer,
p.(None): 4. those conformity assessment procedures which may be initiated by the authorized representative,
p.(None): 5. the storage and provision of documents in connection with conformity assessment procedures,
p.(None): 6. The more detailed requirements under which an exemption according to § 32 can be granted, as well as Art. Content, implementation and treatment
p.(None): the related requests,
p.(None): 7. Art. Content and requirements of the declarations to be issued for custom-made products as well as type and content of those for the responsible authorities
p.(None): available documentation,
p.(None): 8. Art. Content, availability and transmission of records of custom-made products that have been placed on the market or put into operation,
p.(None): 9. Which conformity assessment procedures may have to be carried out when medical devices are manufactured in health care facilities
p.(None): or put into operation.
p.(None): (3) The Federal Minister of Health and Consumer Protection can in a regulation in accordance with paragraph 1, as far as it is in the interest of a uniform and
p.(None): proper implementation of the conformity assessment and the procedure for the placing on the market of systems, treatment centers and the
p.(None): sterilizing CE-marked medical devices in accordance with the relevant directives of the European Union, also specify:
p.(None): 1. the procedure with different interpretations of the provisions of this federal law concerns the conformity assessment of medical devices
p.(None): as part of conformity assessment procedures,
p.(None): 2. more detailed regulations on the recognition of intermediate tests in the context of 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 the notified bodies within the framework of
p.(None): Conformity assessment procedures and
p.(None): 5. the procedure for systems and treatment units as well as for the sterilization of medical devices in accordance with §§ 33 to 35 including for this
p.(None): necessary explanations.
p.(None): (4) The Federal Minister of Health and Consumer Protection, insofar as this applies to the protection of the health and safety of patients,
p.(None): Users and third parties or the prevention of significant risks is required by regulation conformity assessment procedures for medical devices for in-vitro
p.(None): Prescribe diagnosis as a prerequisite for placing on the market and commissioning and specify its type. Content and implementation.
p.(None): Section 29. (1) Sets the conformity assessment procedure in accordance with an ordinance in accordance with Section 28 (1) or the procedure in accordance with Sections 33 to 35
p.(None): Involvement of a notified body, the manufacturer or his authorized representative can contact a body designated for the performance of these tasks
p.(None): Turn choice. The simultaneous referral of several notified bodies as part of a conformity assessment procedure for a medical device by the
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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 the patient, the user or third parties, even if they are properly installed and put into operation,
p.(None): maintained and used for its intended purpose, or
p.(None): 2. do not meet the basic requirements within the meaning of §§ 8, 9, a regulation according to § 10 or, if applicable, the requirements of § 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 have defects that can endanger patients, users or third parties,
p.(None): it has to take all suitable measures to withdraw these products from the market, to ensure that they are placed on the market for the first time and further,
p.(None): their commissioning and their operation, to prohibit their use or use, or to depend on compliance with certain requirements
p.(None): or to make users, patients and third parties aware of dangers or suitable precautionary measures. So far for prevention immediately
p.(None): If there are imminent threats to health and safety, the Federal Office for Safety in Health Care can take these measures without
p.(None): previous procedure or before issuing a decision. However, a written notification must be issued within four weeks.
p.(None): (2) Regarding measures in accordance with paragraph 1 of medical devices that are provided with a CE marking in accordance with this Federal Act, the
p.(None): Federal Minister of Health and Consumer Protection on this subject to the Commission of the European Union and the other contracting parties to the agreement
p.(None): to inform the European Economic Area.
p.(None): (2a) Measures in accordance with paragraph 1 may also include medical devices whose release by the customs authorities in accordance with Article 27 paragraph 3 of the
p.(None): Regulation (EC) № 765/2008 has been suspended. In this case, the products in question are in temporary storage in accordance with Article 50 of the Regulation
p.(None): (EEC) No 2913/92 of the Council of 12 October 1992 establishing the Community Customs Code, OJ. 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 preventing the harmful effects of types of medical devices
p.(None): or groups or to protect patients, users or third parties by ordinance if this is for reasons of
p.(None): Health protection, medical device safety or in the interest of public health, and the Commission and the others
p.(None): Contracting parties to the European Economic Area to be informed accordingly. The Federal Minister of Health has also required by ordinance
p.(None): accompanying provisions, in particular regarding the determination of enforcement responsibilities, with regard to relevant regulations of the European Union
p.(None): adopted.
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 within the scope of the European Economic Area and
p.(None): has its seat in the area of application of this federal law, has a person with the expertise and reliability necessary for the performance of his work
p.(None): to be appointed as a safety officer for medical devices.
p.(None): (2) The safety officer for medical devices has to collect, assess and disclose reports about risks associated with medical devices
p.(None): coordinate necessary measures in accordance with § 72. 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 can, insofar as this is in view of the guarantee of medical device safety and the
p.(None): Defense against risks appears necessary, by regulation more detailed provisions on 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 commission persons such as those within the scope of the
p.(None): Seek professional practice in order to provide them with technical information on the respective medical devices and in the proper handling of the medical devices
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p.(None): Performs activities without complying with Section 98 (5),
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. visits people for the purpose of collecting orders for medical devices within the meaning of Section 101 or places the order therefor,
p.(None): 41. Use labels or presentations, make statements or announcements that are misleading or suitable within the meaning of Section 102,
p.(None): 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. contrary to Section 108, requests, promises or accepts a premium, financial or material advantages,
p.(None): 45. contrary to Section 112, places medical devices on the market, puts them into operation or operates or uses them in healthcare facilities,
p.(None): is guilty of an administrative offense if the act is not threatened with judicial punishment and is subject to a fine of up to € 25,000
p.(None): Repeat trap up to € 50,000.
p.(None): Section 111a. For all personal names used in this federal law, the chosen form applies to 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 Federal Minister of Finance, may charge fees for this
p.(None): Federal acts and activities to be carried out by federal agencies, the necessity of which is derived from this federal law and the
p.(None): based on regulations or relevant legal acts of the European Union adopted in a tariff. The tariff can also
p.(None): Fees for reports in accordance with Section 67 and for reports in connection with implant registers in accordance with an ordinance in accordance with Section 73 are set.
p.(None): (2) When determining the fee-based facts, on the one hand, the experience has shown that the average costs arise, on the other hand
p.(None): to take due account of the importance or the benefit for the debtor. The tariff and its changes are in the “Official Gazette of Vienna
p.(None): Newspaper ”.
p.(None): (3) Does this result from this federal law, the regulations issued on the basis thereof or from legal acts of the European Union
p.(None): The necessity for official acts or activities of federal agencies for which a tariff has not been set are those that actually arise
p.(None): To prescribe costs.
p.(None): (4) For cash expenses, irrespective of the fees set in the tariff in accordance with Section 76 of the General Administrative Procedure Act 1991,
p.(None): 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 as physically available individual products according to the on December 31, 1994 in
p.(None): Regulations that were in force before 15 June 1998 were placed on the market in Austria, 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 the requirements according to § 8 are not met or it
p.(None): measures are taken in accordance with Section 77.
p.(None): (2) Medical devices for in vitro diagnosis, which comply with the regulations that were in force in Austria on December 7, 1998, may still be used until
p.(None): placed on the market in Austria at the end of December 6, 2003. In vitro diagnostic medical devices placed on the market in this way may be used until the end of the
p.(None): December 6, 2005 will continue to be placed on the market or put into operation in Austria, unless the requirements according to §§ 8, 9 and 11 are not
p.(None): fulfilled or measures are taken according to § 77. There are changes to these regulations for the purpose of protecting human beings from one
p.(None): apply direct or indirect health hazards.
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Social / Women
Searching for indicator women:
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p.(None): Class I and Class IIa within the meaning of Directive 93/42 / EEC or for in vitro diagnostics within the meaning of Directive 98/79 / EC in duly justified cases
p.(None): not necessary if the correct and safe use of the medical device is guaranteed without instructions for use.
p.(None): (4) The labeling of medical devices and, in accordance with paragraph 3, their instructions for use must include the name or company name and address of the
p.(None): Manufacturer.
p.(None): (5) Provided that medical devices are imported into the scope of the Agreement on the European Economic Area to be put into circulation there for the first time
p.(None): to be brought, the label, if necessary the outer packaging or the instructions for use, also the name or the
p.(None): The company and the address of the person responsible for the first placing on the market, in the case of in-vitro diagnostics of the authorized representative, if not included
p.(None): is identical to the manufacturer.
p.(None): (6) Medical devices may only be given to the user or consumer if the information intended for him or the patient is given in
p.(None): German language are written. The Federal Minister of Health and Consumer Protection can by ordinance taking into account a sufficient
p.(None): Information for patients and users and taking into account the guarantee of medical device safety exceptions to the requirement of
p.(None): Allow German language or provisions on the admissibility of other suitable measures than the package leaflet for informing the user
p.(None): Provide users or patients.
p.(None): § 10. The Federal Minister of Health and Women has with regard to ensuring the medical performance of medical devices according to § 2
p.(None): and with regard to the protection of the health and safety of patients, users and, where appropriate, third parties and the prevention of risks by regulation
p.(None): 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 only be placed on the market, erected, without prejudice to Sections 6 to 9 and a regulation pursuant to Section 10
p.(None): Operated and used if the requirements in accordance with paragraph 2 and a regulation in accordance with paragraph 3 are also met.
p.(None): (2) Medical devices for in vitro diagnosis must be designed and manufactured in such a way that they take into account the generally recognized state of the art
p.(None): Technology is suitable for the purpose specified by the manufacturer in accordance with Section 2 (5). You need the performance parameters, especially with regard to
p.(None): the sensitivity, specificity, precision, accuracy, reproducibility and detection limits specified by the manufacturer correspond. The traceability of the
p.(None): The values ascribed to the calibration substances or devices or control materials must be determined by available higher-level reference measurement methods and
p.(None): Reference materials can be guaranteed.
p.(None): (3) The Federal Minister of Health and Consumer Protection may use medical devices for in-vitro diagnosis, insofar as this is in view of the
p.(None): Ensuring the medical performance of such medical devices in accordance with Section 2 Paragraph 5 and with regard to the protection of health and safety
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p.(None): (4) In the removal, collection and use of tissue, cells and materials of human origin in the context of manufacture, application and
p.(None): Use of in vitro diagnostic medical devices is to protect human dignity and integrity and privacy. With regard to corresponding
p.(None): Diagnostic measures is the confidentiality of personal data Art. 4 Z 1 of Regulation (EU) 2016/679 for the protection of natural persons at the
p.(None): Processing of personal data, the free movement of data and the repeal of Directive 95/46 / EC (General Data Protection Regulation), OJ. № L 119 from
p.(None): May 4, 2016 p. 1 by means of suitable precautions and discrimination based on genetic systems is not permitted.
p.(None): statutory authorizations
p.(None): § 12. Regulations in accordance with § 10 and § 11 paragraph 3 are, insofar as it concerns the electrical safety and the of the measure and calibration law, BGBl. № 152/1950,
p.(None): recorded measurement functions of medical devices, in agreement with the Federal Minister for Economic Affairs.
p.(None): Section 2
p.(None): Harmonized standards
p.(None): § 13. (1) Insofar as harmonized standards within the meaning of this Federal Act are observed, it can be assumed that the respective provisions of this
p.(None): Federal law is complied with, unless the cases of § 14 or § 77 exist.
p.(None): (1a) The manufacturers must comply with the Common Technical Speci fi cations. Come to these speci fi cations in duly justified cases
p.(None): not, you have to choose solutions that are at least equivalent to the level of the specifications.
p.(None): (2) The Federal Minister for Health and Women has the sources of the relevant national harmonized standards, the relevant monographs
p.(None): the European Pharmacopoeia and the relevant Common Technical Specifications in the Federal Law Gazette.
p.(None): § 14. The Federal Minister of Labor, Health and Social Affairs, if there is reasonable suspicion that the harmonized standards and these
p.(None): Relevant monographs of the European Pharmacopoeia and Common Technical Speci fi cations, which are equivalent to § 2 Para
p.(None): do not meet the basic requirements in the sense of §§ 8 and 9 and a regulation according to § 10, in addition to any necessary measures according to
p.(None): §§ 68, 75 or 77 to initiate the procedures provided for this at Community level in accordance with Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC.
p.(None): Section 3
p.(None): CE marking
p.(None): Section 15. (1) Medical devices with the exception of custom-made devices, medical devices according to Section 32, medical devices intended for clinical testing
p.(None): as well as in vitro diagnostics for performance evaluation purposes may only be placed on the market and put into operation if they have been
p.(None): Labeling according to this federal law or on the basis of directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC
p.(None): other parties to the 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 apply to them taking into account their intended purpose,
p.(None): and
p.(None): 3. a conformity assessment prescribed for the respective medical device in accordance with an ordinance pursuant to Section 28, which entitles the holder to conduct the
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p.(None): (3) If the patient gains the consent, he must be informed immediately that a clinical trial in an emergency situation is on him
p.(None): was or will be carried out. It must be clarified in the sense of Sections 49 and 50. 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. Further processing of the data processed up to that point requires the
p.(None): express consent under data protection law.
p.(None): (4) As soon as the consent can be obtained from the legal representative, a continuation of the clinical trial is only under the conditions
p.(None): of § 51 permitted.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, the data processed up to that point may be used for the purposes of this clinical
p.(None): Testing can be used.
p.(None): Section 53. The clinical trial of a medical device may only be carried out on a pregnant or breastfeeding mother if
p.(None): 1. the medical device to be tested to achieve a purpose according to § 2 paragraph 1 for nursing mothers, pregnant women or unborn children
p.(None): is determined
p.(None): 2. the application of the medical device according to the knowledge of medical science is indicated to the nursing mother or
p.(None): Pregnant women on whom the clinical trial is being carried out or the purpose of their unborn child in accordance with Section 2 (1),
p.(None): 3. According to the knowledge of medical science, conducting the clinical trial is not expected to pose any risks to the unborn or
p.(None): brings breastfed child with him and
p.(None): 4. According to the knowledge of the medical sciences, the clinical trial is only sufficient on pregnant women or nursing mothers
p.(None): Exam results can be expected.
p.(None): § 54. The clinical trial of a medical device may not be carried out on persons who do a presence or training or community service.
p.(None): Dealing with data
p.(None): § 55. (1) During the entire course of the clinical trial, patient-related data of all persons involved are strictly confidential
p.(None): to treat. All patient-related data must be protected against unauthorized access and, as far as possible, pseudonymized, ensuring that
p.(None): is that the additional information with which the personal data can be assigned to an affected person is kept separately
p.(None): become.
p.(None): (2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and confidential handling of all within the framework of a
p.(None): clinical trial data.
p.(None): (3) The study plan, the final report and all data and documents created in connection with the clinical study are for specific periods
p.(None): after completion or termination of the clinical trial, which the Federal Minister of Health and Consumer Protection issues in a regulation
p.(None): Section 66 are to be laid down. This regulation also specifies who is responsible for keeping certain data or documents.
p.(None): (3a) For the period of the retention periods, the right according to Art. 17 General Data Protection Regulation is excluded.
p.(None): (4) All data and documents relevant to the clinical trial must be submitted to the Federal Office for Safety in Health Care upon request
p.(None): Verification of compliance with the provisions of this federal law on clinical trials are made available.
p.(None): Quality control and quality management
...
p.(None): ethics committees
p.(None): Section 57. (1) The clinical examination of a medical device may only be carried out if the assessment has been carried out by the responsible ethics committee
p.(None): has been caught up.
p.(None): (2) Within the framework of a multicenter examination, a responsible ethics committee can comment on the opinion of another person responsible for this clinical examination
p.(None): Declare ethics committee sufficient. In this case, the assessing ethics committee must also announce all involved auditors and all
p.(None): Documents are made available that provide an assessment with regard to their professional quali fi cation and experience as well as the existing facilities
p.(None): and allow the staff.
p.(None): § 58. (1) With regard to clinical trials outside of hospitals, the governor must ensure that in the area of his
p.(None): A sufficient number of independent state ethics committees are set up to perform the tasks set out in Section 60.
p.(None): (2) For the clinical examination at hospitals, the responsible ethics committee in accordance with Section 8c of the Hospitals Act, Federal Law Gazette No. 1/1957.
p.(None): (3) The appointment of ethics committees in accordance with paragraph 1 is to the Federal Ministry of Health and Women and the Federal Office for Security in the
p.(None): 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 not covered by Z 1 to 8, who is entrusted with the pastoral care or otherwise through the
p.(None): required ethical competence. Additional experts should be consulted if the assessment of a clinical trial requires it. The
p.(None): Ethics Committee has to be made up of women and men. If possible, care should be taken to ensure a balanced relationship. For each
p.(None): A representative is to be appointed. The members of the ethics committee listed in Z 1 and 2 may not at the same time clinical investigators within the scope of the
p.(None): assessing clinical trial.
p.(None): Section 59. (1) The members of the ethics committee and their deputies must be free of instructions in this function. You have any relationships with manufacturers
p.(None): or distributors of medical devices to the governor in full. They have become active in the ethics committee -
p.(None): without prejudice to any other reasons for bias - to include in all matters in which such a relationship is appropriate, their full
p.(None): To question impartiality.
p.(None): (1a) Within the framework of the organization, internal quality assurance measures are to be provided, which include in particular the regularity of the processes and
p.(None): Ensure procedures.
p.(None): (2) The implementation of the agendas of the ethics committee and the proper completion of its decisions and statements is in one
p.(None): To set down the rules of procedure in writing, which require the approval of the responsible governor.
p.(None): (3) The sponsor or clinical investigator must provide the ethics committee with all the necessary documents for assessing the clinical trial in accordance with § 43,
p.(None): in particular also evidence of qualifications, the test plan, the evidence of the technical safety of the medical device, the preclinical documents, the
...
p.(None): stipulate the required information by ordinance Art. Content, 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 the directive 93/42 / EEC and for in-vitro diagnostics of Annex II and in-vitro diagnostics
p.(None): The Federal Minister of Health may notify the Federal Minister of Health of all information that identifies the medical device in order to apply Directive 98/79 / EC
p.(None): enable and determine the labeling and instructions for use if these medical devices are in operation within the scope of this federal law
p.(None): be taken. The Federal Minister of Health can also use this ordinance with regard to reporting requirements, modalities and access authorizations
p.(None): commit to the European database as defined by Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC.
p.(None): Section 2
p.(None): monitoring
p.(None): Section 68. (1) Companies, facilities or persons who deal with medical devices professionally or commercially, in particular manufacture medical devices,
p.(None): Check, store, transport, pack, exhibit, place on the market or assemble the medical devices professionally or within the meaning of Section 33 (1)
p.(None): Maintain, convert, assemble, adapt or process commercially, clean, disinfect or professionally or professionally clean medical devices
p.(None): sterilize or use or operate the medical devices in healthcare facilities are subject to the following with regard to these activities
p.(None): Monitoring.
p.(None): (2) Monitoring within the meaning of paragraph 1 is carried out by the organs of the Federal Office for Safety in Health Care, the Federal Minister for
p.(None): Health and women or by experts commissioned by them. The activity of relevant accredited bodies, from
p.(None): Federal Minister of Health and Women recognized organizer of proficiency tests, operators of medical device registers or other organizers
p.(None): supra-regional comparative tests and assessments in connection with medical devices recognized by the Federal Minister of Health and Women
p.(None): be included.
p.(None): (3) Insofar as monitoring is provided within the scope of conformity assessment procedures in accordance with an ordinance pursuant to Section 28, this is carried out by
p.(None): the relevant notified body responsible for the conformity assessment procedure. Monitoring by notified bodies is carried out in accordance with a regulation
p.(None): § 28.
p.(None): (4) The monitoring according to Paragraph 1 can relate to all aspects relating to the safety, functionality and quality of medical devices as well as the
p.(None): Protect the safety and health of patients, users or third parties.
p.(None): (5) The monitoring of health care facilities can be systematic, taking into account the respective hazard potential,
p.(None): carried out on a random basis or in the event of an incident, in particular with regard to possible dangers to the life or health of patients or users
p.(None): or third parties in connection with medical devices or with a view to ensuring quality-assured availability, use and
p.(None): Maintenance of medical devices in the interest of health. Is there a violation of provisions of this federal law or on the basis thereof
p.(None): decrees, the institution must be instructed to remedy the defects within a reasonable period of time. Comes in surveillance
p.(None): that a violation of provisions of this federal law or on the basis of ordinances issued on it
p.(None): Health of patients, users or third parties is endangered, so are the necessary measures to protect the life and health of these
p.(None): Meet people.
p.(None): (6) The monitoring of facilities and establishments, which of establishments, facilities or persons within the meaning of paragraph 1 with the storage and the
p.(None): Transport of medical devices has only been commissioned if circumstances exist that justify the assumption that medical devices are stored
p.(None): or the means of transport are used for other purposes than storage facilities beyond the time required to complete the transport agenda.
p.(None): (7) The organs of the Federal Office for Safety in Health Care, the Federal Ministry for Health and Women and those pursuant to para. 2
p.(None): commissioned experts are authorized to
p.(None): 1.On entering and inspecting real estate, business premises, business premises, means of transport in or on which an activity has been carried out in accordance with paragraph 1
p.(None): becomes,
p.(None): 2. to inspect and test medical devices, especially to put them into operation and to take samples,
p.(None): 3. to inspect and check any necessary measuring and testing equipment,
p.(None): 4. the documents to be kept available on the basis of this federal law or the decrees issued under this federal law
p.(None): a) Development, production, testing, clinical testing and evaluation, performance evaluation testing and performance evaluation of in vitro diagnostic medical devices,
p.(None): Acquisition, storage, packaging, placing on the market and other whereabouts of the 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, in particular also in accordance with Section 72,
p.(None): e) the information and advertising material on the market,
p.(None): f) the performance of testing, monitoring and certification activities in accordance with this Federal Act,
p.(None): g) the conformity assessment,
p.(None): h) the fulfillment of the basic requirements within the meaning of §§ 8 and 9 and a regulation according to § 10 and others for medical device safety
p.(None): relevant information
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 and the organs of the
p.(None): Federal Office for Safety in Health Care, the 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 required to make the premises, medical devices and records available to them
p.(None): to allow prescribed or officially ordered testing, to provide the necessary staff and aids for this, and to provide the information and
p.(None): to submit the documents necessary for the performance of the tasks of the bodies responsible for monitoring or of the experts commissioned in accordance with paragraph 2
p.(None): required are.
p.(None): (9) The official acts in accordance with paragraphs 5 to 8 are, except in the event of imminent danger or if there is a reasonable assumption that the effectiveness of the
p.(None): Official action is impaired to perform during the operating hours and to announce beforehand. The organs and the experts according to paragraph 2 have
p.(None): in the course of their surveillance, taking care that any disruption or hindrance to the activities of undertakings which is not absolutely
p.(None): Facilities or persons in accordance with paragraph 1 is avoided.
p.(None): (10) The Federal Minister of Health and Women has from the point of view of an expedient and effective control for the following
p.(None): To issue a directive on the implementation of the inspections (inspection plan) during the calendar year. 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 March 31 of the following calendar year on enforcement
p.(None): to report.
p.(None): (11) Market surveillance authority within the meaning of Regulation (EC) № 765/2008 of the European Parliament and of the Council of 9 July 2008 on the
p.(None): Regulations for accreditation and market surveillance in connection with the marketing of products and repealing the regulation (EEC)
p.(None): No. 339/93 for products within the meaning of this federal law is the Federal Office for Safety in Health Care.
p.(None): (12) The Federal Office for Safety in Health Care has in accordance with the requirements of the Federal Ministry of Health
p.(None): Develop market surveillance programs for medical devices and regularly update and implement them. These are the Federal Minister for
p.(None): Submit health for approval. The Federal Office for Safety in Healthcare has these programs in the other Member States and the
p.(None): To be communicated to the European Commission and made available to the public by electronic means of communication and, if necessary, by other means
p.(None): put.
p.(None): (13) The Federal Ministry of Health operates the market surveillance activities of the Federal Office for Safety in Health Care
p.(None): Check and evaluate regularly, but at least every four years. The results of these reviews are the other Member States and the
p.(None): To be communicated to the European Commission and made accessible to the public by electronic means of communication and, if necessary, other means
p.(None): do.
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, facilities or persons who carry out testing, monitoring and certi fi cation activities
p.(None): carry out according to this federal law.
...
p.(None): Maintenance of medical devices
p.(None): Section 85. (1) Medical devices are comprehensible and professional, taking into account the manufacturer's information through inspection, maintenance and repair
p.(None): to be maintained in such a way that the functionality and safety of patients, users and third parties is guaranteed over their service life.
p.(None): (2) Inspection, maintenance and repair as well as all related tests may only be transferred to persons or bodies who, on the basis of their
p.(None): technical training and their experience gained through practical work as well as their knowledge, especially with regard to the relevant
p.(None): Legislation and standards are able to take and assess the measures required for this, as well as the possible effects and
p.(None): Recognize dangers and carry out their work properly. They must carry out and evaluate the exams in their professional
p.(None): Assessment must be free of instructions.
p.(None): (3) Healthcare facilities must take all necessary precautions for the proper maintenance of medical devices.
p.(None): (4) Provided that the corresponding types, groups or classes of medical devices are listed in an ordinance pursuant to Section 92
p.(None): 1. the providers of social insurance as well as medical and / or accident care for medical devices, which the insured / insured depend on
p.(None): Are made available for treatment in a home environment or for personal use or as part of insurance
p.(None): / Utilities are at least partially reimbursed in costs, and
p.(None): 2. Institutions that use life-saving or other health-relevant medical devices in their or in a public area for use
p.(None): keep ready,
p.(None): to take the necessary precautions for their proper maintenance. The Federal Minister of Health and Women made the determination
p.(None): of these medical devices in a regulation in accordance with Section 92 each on significant risks to the health and safety of patients and on
p.(None): Take into account any deterioration in the performance of these medical devices that would be expected in the absence of proper maintenance. In the
p.(None): Ordinance according to § 92 may also have special requirements with regard to the proper preparation and use of these medical devices and
p.(None): regarding the required training measures.
p.(None): § 86. After the repair of medical devices, the essential structural and functional requirements for safety and functionality
p.(None): Features are checked as far as they can be affected by the repair.
p.(None): Recurring safety-related tests of medical devices
p.(None): Section 87. Health care institutions must ensure that medical devices listed in an ordinance pursuant to Section 92 are of an appropriate type
p.(None): technically suitable person or position are checked regularly.
p.(None): § 88. (1) The tests in accordance with § 87 have considering the type of the medical device to be tested and the information of the manufacturer in one
p.(None): The scope is sufficient to be able to assess the safety and functional condition of the medical device. Accessories or
p.(None): Product combinations that can influence the medical device to a significant degree in safety must be taken into account.
p.(None): (2) The Federal Minister of Health and Consumer Protection has in the regulation according to § 92 with regard to the safety of patients, users and
p.(None): Third, and the proper condition of medical devices to designate those types, groups, or classes of medical devices that are regular
...
p.(None): Quality management systems with regard to the construction, application, operation, maintenance, disinfection and sterilization of medical devices
p.(None): or certain types or groups of medical devices in healthcare facilities and to ensure compliance with the requirements
p.(None): in accordance with a regulation in accordance with paragraph 2, stipulate requirements and requirements for those bodies that have quality management systems in accordance with paragraphs 1 and 2
p.(None): check, monitor or certify. He has to take into account any relevant national and international standards.
p.(None): § 96. The Federal Minister of Health and Consumer Protection has, if this is with regard to serious interests of public health or
p.(None): the prevention of serious risks is required by regulation the use or operation of certain types or groups of medical devices
p.(None): Restrict healthcare institutions, whose quality management systems in this regard demonstrably meet the requirements of a regulation
p.(None): in accordance with section 95 (1) or certified in the sense of a regulation in accordance with section 95 (2).
p.(None): minimum standards
p.(None): § 97. The Federal Minister of Health and Consumer Protection has, if this is with regard to serious interests of public health or
p.(None): the prevention of serious risks is required with regard to certain medical services by regulation minimum standards for the provision of these
p.(None): 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 of Economics and Labor, provided that this is under
p.(None): Consideration of proper operation and the required quality, safety and performance of medical devices as well as the protection of safety
p.(None): and health of the patient, the user or third parties is required by regulation special provisions for companies or facilities that
p.(None): Manufacture, place on the market, process or store medical devices within the scope of this federal law.
p.(None): (2) In a regulation in accordance with paragraph 1, users are users with regard to the safety and performance of medical devices and the protection of patients
p.(None): or third parties in particular to make regulations about
p.(None): 1. production, storage, acquisition and distribution,
p.(None): 2. precautions for information and advice as well as instruction in the operation and use 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 the prevention of risks,
p.(None): 8.Maintenance of medical devices in healthcare facilities and at other operators or users,
p.(None): 9. Measures for quality management in the manufacture and other handling of 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 the operational processes relevant for medical devices.
p.(None): (3) In a regulation according to paragraph 1 it should also be provided that certain companies manufacture and store and trade in medical devices
...
p.(None): Section 1
p.(None): Confidentiality and automated data traffic
p.(None): § 110. Unless there are other statutory confidentiality obligations, persons are tasks related to the execution
p.(None): of this federal law are bound to secrecy about all facts that have become known to them exclusively from this activity.
p.(None): Section 110a. (1) To ensure the safety of medical devices and to ensure the protection of life and health of people, those for
p.(None): the completion of this federal law requires data (Art. 4 Z 1 General Data Protection Regulation) about the production, the placing on the market, the availability,
p.(None): building, using, testing, clinical evaluation and testing, performance evaluation and performance evaluation examination, preparation, the
p.(None): Commissioning, quality management, maintenance, market monitoring and vigilance of medical devices processed with automation support
p.(None): become.
p.(None): (2) To ensure the safety of medical devices and to ensure the protection of life and health of people, those for
p.(None): Enforcement of this federal law with regard to the personal data of patients required for medical device monitoring as well
p.(None): Subjects are processed in an automated manner in connection with the use of medical devices. Processing this
p.(None): Data by the Federal Office for Safety in Health Care must be in pseudonymised form, as long as the data is used for the purposes of
p.(None): Medical device monitoring in this form is required.
p.(None): (3) The Federal Office for Safety in Health Care is authorized to provide data in the sense of paragraphs 1 and 2 with automated support
p.(None): 1. the Federal Ministry of Health and Women and subordinate authorities for the purposes of paragraph 1,
p.(None): 2. the Austrian Agency for Health and Food Security, the Advisory Board in accordance with Section 117 (2) and experts, provided that they are in enforcement
p.(None): this Federal Act assigns tasks that correspond to the intended use of paragraphs 1 and 2,
p.(None): 3. the Austrian Federal Institute for Health Care, university institutes and other research institutions, insofar as they are in the interest
p.(None): are active in public health, for tasks within the meaning 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 the federal states, the Austrian
p.(None): Dentists' Chamber, the umbrella organization of high-level medical-technical services, the midwifery committee, the social insurance institutions and the
p.(None): Umbrella organization of social insurance institutions, insofar as this data is an essential prerequisite for the tasks assigned to them by law,
p.(None): 5. the health care facilities insofar as they place or use medical devices on the market and the safe use or protection of the
p.(None): Life or human health 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 European Economic Area and the European
p.(None): Commission for tasks within the meaning of the intended use of paragraphs 1 and 2
p.(None): to transmit.
p.(None): (4) The Federal Office for Safety in Health Care and the Federal Ministry for Health and Women or a body designated by the latter
p.(None): further authorized to use data within the meaning of Article 14a of Directive 93/42 / EEC on medical devices and Article 12 of Directive 98/79 / EC on in vitro diagnostic medical devices
p.(None): enter the European database provided there and the necessary information to the competent authorities and notified bodies of the contracting parties
p.(None): of the Agreement on the European Economic Area and the European Commission to ensure a uniform application of the to implement the
p.(None): 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 Section 6, erects, installs, commissions or uses it or places it on the market contrary to Section 7 (1)
p.(None): or put into operation,
p.(None): 2. delivers a medical device to users, consumers or patients without any information corresponding to § 9,
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, is not provided with the CE marking,
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 or does not comply with Section 27 or one
p.(None): Ordinance pursuant to Section 28 has been made
p.(None): 7. as a manufacturer of a custom-made product or as his authorized representative does not meet his obligations under Section 30,
p.(None): 8. Issues a medical device for demonstration purposes without fulfilling its obligations under Section 31,
...
p.(None): 36. as the operator of a health care facility, does not have the minimum equipment available in accordance with an ordinance pursuant to Section 97,
p.(None): 37. runs an operation contrary to the special regulations for operation in accordance with an ordinance pursuant to Section 98 (1) or as defined in Section 98 (5)
p.(None): Performs activities without complying with Section 98 (5),
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. visits people for the purpose of collecting orders for medical devices within the meaning of Section 101 or places the order therefor,
p.(None): 41. Use labels or presentations, make statements or announcements that are misleading or suitable within the meaning of Section 102,
p.(None): 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. contrary to Section 108, requests, promises or accepts a premium, financial or material advantages,
p.(None): 45. contrary to Section 112, places medical devices on the market, puts them into operation or operates or uses them in healthcare facilities,
p.(None): is guilty of an administrative offense if the act is not threatened with judicial punishment and is subject to a fine of up to € 25,000
p.(None): Repeat trap up to € 50,000.
p.(None): Section 111a. For all personal names used in this federal law, the chosen form applies to 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 Federal Minister of Finance, may charge fees for this
p.(None): Federal acts and activities to be carried out by federal agencies, the necessity of which is derived from this federal law and the
p.(None): based on regulations or relevant legal acts of the European Union adopted in a tariff. The tariff can also
p.(None): Fees for reports in accordance with Section 67 and for reports in connection with implant registers in accordance with an ordinance in accordance with Section 73 are set.
p.(None): (2) When determining the fee-based facts, on the one hand, the experience has shown that the average costs arise, on the other hand
p.(None): to take due account of the importance or the benefit for the debtor. The tariff and its changes are in the “Official Gazette of Vienna
p.(None): Newspaper ”.
p.(None): (3) Does this result from this federal law, the regulations issued on the basis thereof or from legal acts of the European Union
p.(None): The necessity for official acts or activities of federal agencies for which a tariff has not been set are those that actually arise
p.(None): To prescribe costs.
p.(None): (4) For cash expenses, irrespective of the fees set in the tariff in accordance with Section 76 of the General Administrative Procedure Act 1991,
p.(None): 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 as physically available individual products according to the on December 31, 1994 in
p.(None): Regulations that were in force before 15 June 1998 were placed on the market in Austria, and
p.(None): 1. which are safe and efficient,
p.(None): 2. whose expiry date has not passed and
...
p.(None): Version of the Federal Law BGBl. I No. 117/1999 come into force on June 7, 2000.
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, section 67 subsections 1 to 3, section 76 subsection 2, section 77 subsection 3, section 111 line 19a,
p.(None): Section 112 (1) and (2), Section 113, Section 116a, Section 117 (1) (2) of this Federal Act as amended by Federal Law BGBl. I No. 117/1999 shall come into force on December 7, 1999
p.(None): in force.
p.(None): (5) § 104 and § 111a in the version of the Federal Law BGBl. I № 33/2002 occur one month after the announcement of the Federal Law BGBl. I
p.(None): No. 33/2002 following the first day of the month.
p.(None): (6) Section 5 (3) and Section 29 in the version of Federal Law BGBl. I No. 119/2003 enter into force upon the 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 (2) 1 and 2, section 41 subsection 5, section 44, section 55 subsection 4, section 56 subsection 3,
p.(None): Section 58 subsection 3, Section 67 subsection 1, 3 and 4, Section 68 subsection 2, 7, 8 and 10, Section 70 subsection 1, 3 and 4, Section 71, Section 75 and Section 76 subsection 2, Section 77 (1), Section 79 (2), Section 98 (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) As of December 31, 2005, pending proceedings pursuant to the provisions listed in Paragraph 7 are required by the Federal Office for Security
p.(None): to continue in healthcare. The administrative files are immediately from the Federal Ministry of Health and Women to the Federal Office for Security
p.(None): to forward 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, Paragraphs 2, 2a, 2b, 4, 5, 8, 9 and 15, § 4 Abs. 1 Z 1, 4 and 6, § 4a,
p.(None): §§ 5a and 5b including headings, § 8 paragraphs 4 and 5, the introductory words of § 15 paragraph 2, § 22 paragraphs 2 and 3, § 23, §§ 26a and 26b including heading, § 28 paragraph 2 line 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 Section 1 of III. Main piece, § 38, § 40, §§ 40a
p.(None): and 40b including headings, § 41 paragraph 1, 2, 4 and 6, § 42 paragraph 8, § 43, § 44, § 47 paragraph 1, 2 and 3, § 49, § 50 paragraph 1, 2 and 4, § 51, § 52a para. 3, § 56 para. 3 to 7,
p.(None): Section 59 subsection 1, 1a and 3, Section 60 subsection 1 to 3, Section 61, Section 63 subsection 4 to 6, Section 64 subsection 1, 4 and 7, Section 65, Section 65a subsection 1 and 2, Section 66, Section 67 subsection 7, Section 70 subsection 1, 3, 4, 6 and 7, Section 77
p.(None): Para. 1 Z 2a and 3, § 77 Paragraph 2a, § 111 Z 5, 13 and 15, § 113, § 116 Paragraph 2 and 3, § 116a Z 7, as amended by Federal Law BGBl. I № 143 / 2009 join
p.(None): March 21, 2010 in force. Section 68 (11) to (13) as amended by Federal Law Gazette I No. 143/2009 comes into force on January 1, 2010.
p.(None): (10) Data protection consent in connection with clinical trials that were issued before May 25, 2018, need not be renewed
p.(None): become.
p.(None): (11) Section 11 (4), Section 49 (4), 5 and 6, Section 50 (1), Section 52a (3) and (5), Section 55 (1), Section 59 (3) and Section 64 (3) 4a, § 73 paragraphs 1, 2, 4, 4a, 5, 6, 8, 11, 12 14, 17,
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Social / Youth/Minors
Searching for indicator minor:
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p.(None): , the consent must be given to a witness who has to confirm the consent with his signature.
p.(None): (2) Unless otherwise stipulated in Section 51, the consent is only legally effective if the exam participant is able to determine the nature, meaning, scope,
p.(None): See the benefits, risks and burdens of 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 several for participation in the clinical trial
p.(None): If consent is required, the clinical trial on this person may not be continued if even one of these consent is withdrawn.
p.(None): (4) The test participants, possibly legal representatives (§ 1034 ABGB), must be informed in writing about the insurance protection according to § 47
p.(None): become.
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): 1. the medical device that is being tested is intended to be used for minors in accordance with Section 2 (1) and the clinical trial
p.(None): for the validation of data obtained during clinical trials on adults or using other research methods
p.(None): is required,
p.(None): 2. the use of the medical device that is being tested, based on the knowledge of medical science, is indicated to the minor,
p.(None): on which the clinical trial is carried out, to achieve a purpose in accordance with Section 2 (1) and which includes inclusion in the clinical trial
p.(None): Exam related benefits for the test subject outweigh the risk
p.(None): 3. The consent of the legal guardian has been demonstrably and in writing given the appropriate information,
p.(None): 4. the minor, prior to the start of the clinical trial, by one of the clinical investigators experienced in dealing with minors, should be able to do so
p.(None): understand has received appropriate information,
p.(None): 5. the consent of the minor who is able to see the nature, meaning, scope and risks of the clinical trial, and
p.(None): its will to be determined according to it has been demonstrably granted, and it is ensured that the wish expressly expressed by a minor,
p.(None): not participating in the clinical trial or ending at any time is considered by the clinical investigator,
p.(None): 6. the consent can be withdrawn at any time without causing a disadvantage for the minor,
p.(None): 7. there are no incentives or financial benefits with the exception of an allowance for participation in the clinical trial,
p.(None): 8. The clinical trial is planned in such a way that it takes into account as little as possible, taking into account the illness and the stage of development of the minor
p.(None): Pain, discomfort, fear and other foreseeable risks are connected, whereby the risk threshold as well as the degree of exposure are specific
p.(None): must be defined and constantly checked,
p.(None): 9. The test plan from an ethics committee that has knowledge in the field of pediatrics and adolescent medicine or that is in clinical, ethical
p.(None): and psychosocial issues in the field of paediatrics and adolescent medicine was advised, endorsed, and
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of science.
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 a significant extension of the scientific understanding of the condition, the illness or the disorder of the minor
p.(None): aims and can thereby benefit either the patient or the patient group to which the minor belongs, and
p.(None): 2. the clinical trial brings minimal risk and burden to the minor; a clinical trial shows a minimal
p.(None): Risk and a minimal burden, if it can be expected that they lead to a minor and only temporary impairment
p.(None): and any symptoms or inconveniences may be very minor and will only occur temporarily.
p.(None): § 52. The clinical trial may be carried out on a person who is suffering from a mental illness or a comparable impairment of their
p.(None): Ability to make decisions has a legal representative or has been stopped by judicial or official order or in accordance with the Accommodation Act,
p.(None): BGBl. No. 155/1990, is not carried out.
p.(None): Section 52a. (1) A clinical trial of its kind can only be used in emergency situations in which, within a reasonable time, no consent of the legal representative
p.(None): can be obtained, a clinical trial can then be performed on a person who is unable to consent,
p.(None): if
p.(None): 1. There are no indications that either the patient refused or would refuse the clinical trial or that the requirements of the
p.(None): § 52 exist,
p.(None): 2. Such research for the validation of data used in clinical trials on persons capable of obtaining informed consent or by means of
p.(None): other research methods have been obtained and are essential 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 is intended to fulfill an intended purpose within the meaning of Section 2 (1) nos. 1 to 3 in an emergency situation,
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Searching for indicator youth:
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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 in the Austrian healthcare system and
p.(None): 5. for scientific purposes
p.(None): To maintain implant registers for active implantable medical devices, soft tissue implants, cardiovascular, 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, specific implant parameters, data on individual implant settings, and
p.(None): 7. Technical, clinical, organizational, temporal and event-related data for aftercare.
p.(None): (3) The implanting / treating healthcare facilities are, if this is to protect the health and safety of patients
p.(None): is necessary, the personal data of Gesundheit Österreich GmbH mentioned in Paragraph 2 and required for the purposes of keeping the register
p.(None): can also be submitted online. Health Austria GmbH is responsible for granting access to health care facilities
p.(None): documented in a comprehensible manner.
p.(None): (4) The Federal Minister for Health, Family and Youth has set up implant registers and the speci fi c data sets for the individual
p.(None): Specify register by regulation. This regulation also includes 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 in accordance with paragraphs 1 and 2, only that is required for patient identification
p.(None): Use of the area-specific personal identifiers GH and AS (Section 10 (2) E-Government Act, Federal Law Gazette I No. 10/2004) permitted. The
p.(None): area-specific personal identifiers AS may only be used and saved in encrypted form. The direct personal reference is immediate
p.(None): irreversibly deleted after conversion.
p.(None): (6) The area-specific personal identifiers are to be deleted as soon as they are no longer required for the purposes set out in paragraph 1. The federal agency
p.(None): "Statistics Austria" has the Health Austria GmbH - upon 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 identity and role of the authorized user at every access
p.(None): be proven and logged according to the state of the art. He must ensure that the appropriate state of the art
p.(None): Appropriate precautions are taken to prevent the destruction or modification of the data by program errors (viruses) and to prevent
p.(None): Prevent destruction, modification or query of the data in the register by unauthorized users or systems. He must also ensure that
...
p.(None): Market surveillance is necessary.
p.(None): (12) The Managing Director of Gesundheit Österreich GmbH is obliged to give access to the individual users of Gesundheit Österreich
p.(None): GmbH individually assign. Health Austria GmbH's authorized users are aware of the provisions of the General Data Protection Regulation and the
p.(None): To teach data security concept. These access rights shall be withdrawn from their access rights if they are used to further fulfill them
p.(None): no longer need the assigned tasks or do not process the data in accordance with their intended purpose.
p.(None): (13) The managing director of Gesundheit Österreich GmbH has to ensure through organizational and technical precautions that access is granted
p.(None): Rooms in which the database server is located can only be accessed by those with access to Health Austria GmbH.
p.(None): (14) If the database server is removed from the area of Gesundheit Österreich GmbH, the managing director of Gesundheit Österreich GmbH
p.(None): ensure that unauthorized use is excluded.
p.(None): (15) The marketers of implants, which are kept in registers according to paragraph 1, are obliged to do what is necessary for the purposes of the register
p.(None): to provide the technical data of your implants to Gesundheit Österreich GmbH in electronic form.
p.(None): Traceability of medical devices
p.(None): Section 73b. The Federal Minister of Health, Family and Youth has, insofar as this is concerned with the protection of the health and safety of patients,
p.(None): Users or third parties and the defense against risks is required, considering types, groups or classes of medical devices with increased
p.(None): Risk potential through ordinance for the placing on the market of medical devices and those responsible for health care facilities
p.(None): To take precautions and measures with regard to the traceability of medical devices and to make stipulations about
p.(None): 1. the types, groups or classes of medical devices that are covered by the traceability requirements,
p.(None): 2. the product or product group-speci fi c requirements with regard to traceability as well as with regard to type, content, speci fi city and availability of
p.(None): records required in this regard, and
p.(None): 3. the manner in which suitable implant registers are set up in healthcare facilities and the necessary records.
p.(None): observational
p.(None): § 74. The Federal Minister of Health and Consumer Protection can consider serious interests of public health and
p.(None): with a view to gaining improved knowledge about the benefit / risk assessment of certain types or groups of medical devices, in particular
p.(None): also about the long-term effects of implantable medical devices that can only be obtained through systematic data collection and analysis
p.(None): can, by regulation, prescribe that relevant data, which have been collected in connection with the use of these medical devices and for which
p.(None): Obtaining these findings are necessary for a central evaluation. As part of the central collection and evaluation
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p.(None): Medical devices and commercial law provisions are concerned, and with regard to Section 99 (1), as far as commercial law concerns are concerned,
p.(None): the Federal Minister for Health and Consumer Protection in agreement with the Federal Minister for Economic Affairs and
p.(None): 4. With regard to Section 98 (1), the Federal Minister for Health and Consumer Protection in agreement with the Federal Minister for Economic Affairs
p.(None): Affairs
p.(None): entrusted.
p.(None): (2) Before enacting ordinances in accordance with this federal law, the federal ministers responsible in accordance with para
p.(None): Experts in the field of matter to be regulated in each 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 Austrian Dental Association, the Federal Chamber of Labor,
p.(None): the Austrian Chamber of Commerce, the Austrian Chamber of Pharmacists, the Main Association of Austrian Social Insurance Institutions, the
p.(None): Belong to Austrian Agency for Health and Nutritional Security GmbH, business unit PharmMed, and the Austrian Senior Council.
p.(None): Furthermore, according to the state law implementing provisions to § 11e of the Federal Law 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, Family and Youth, the activities of the advisory board are updated
p.(None): rules of procedure to be adopted by the Federal Minister for Health, Family and Youth. 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. In agreement with the chairman, the
p.(None): Consult representatives in accordance with paragraph 2 further experts.
p.(None): to the top
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Social / education
Searching for indicator education:
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p.(None): (4) As part of the clinical trial of a medical device, all of the features of the
p.(None): Medical device, including the safety-related and performance-related properties and the effects on the patient.
p.(None): (5) The criteria and test parameters used to ascertain the safety-related characteristics, performance and side effects of a medical device
p.(None): must be determined using suitable observation and measurement methods and must be meaningful with regard to the ascertainment of the benefit / risk ratio.
p.(None): (6) The procedure for carrying out a clinical trial must be adapted to the medical device under test.
p.(None): (7) Clinical trials must be carried out under the intended conditions of use of the medical device.
p.(None): (8) All serious adverse events must be fully registered by the sponsor and immediately reported to the Federal Office for Security in the
p.(None): Healthcare and the competent authorities of the other concerned EEA Contracting Parties in which the clinical trial is being conducted
p.(None): Report.
p.(None): Documentation, documents
p.(None): § 43. For each clinical trial, the objectives, medical, scientific and technical foundations, planning, organization,
p.(None): Conducting and evaluating the clinical trial and beyond for the protection of health, safety, integrity and rights of
p.(None): Exam participants record relevant points of view and precautions in suitable documentation.
p.(None): Section 44. The following documentation and documents must be prepared for each clinical trial and submitted to the Federal Office for Safety in
p.(None): Submit health care:
p.(None): 1. the test plan,
p.(None): 2. the clinical investigator's manual,
p.(None): 3. the information to be used for the education of the test participants and, if applicable, their legal representatives in accordance with § 51 and the
p.(None): Letter of acceptance,
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 that define their responsibilities,
p.(None): 6. the opinions of all ethics committees to be addressed and the points of view that were the subject of these opinions, and
p.(None): 7. the final report.
p.(None): test plan
p.(None): Section 45. (1) There must be a written agreement between the sponsor and the clinical investigator regarding the study plan in accordance with Section 42.
p.(None): (2) The study plan must determine the scientifically sound structure and sequence of the clinical trial and its scientific significance with regard
p.(None): to ensure their objectives and questions.
p.(None): final report
p.(None): Section 46. (1) For each clinical trial, a written final report must be drawn up, signed by all clinical investigators involved in the trial
p.(None): is.
p.(None): (2) The final report must contain a critical evaluation of all scientifically relevant data obtained in the course of the clinical trial.
p.(None): insurance
p.(None): Section 47. (1) The sponsor has to take out personal injury insurance, taking into account paragraph 2, which covers all damage to life or life
p.(None): Health of the test participant can be caused by the clinical trial measures carried out on him and for which the clinical trial
p.(None): Examiners would be liable if they were to blame (§ 1295 ABGB), with the exception of damage due to changes in the genetic material in cells of the
p.(None): Germ line of man.
p.(None): (2) Personal injury insurance in accordance with Paragraph 1 must be taken out in accordance with the following principles:
p.(None): 1. The sponsor must be the policyholder and the exam participant must be an independent insured person.
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 be ensured if necessary.
p.(None): 5. The scope of the insurance must be proportionate to the risks associated with the clinical trial; the
p.(None): The minimum insurance amount is to be determined by ordinance of the Federal Minister of Health and Consumer Protection.
p.(None): (3) The test participant and, in the cases of Section 51, his legal representative must be covered by the insurance cover before the clinical trial begins
p.(None): to inform 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 whether the clinical investigator has sufficient liability.
p.(None): and legal expenses insurance has, if necessary, the clinical investigator arising from the increased risk associated with the clinical trial
p.(None): To adequately replace additional costs for own insurance or suitable insurance for the benefit of the clinical investigator
p.(None): complete.
p.(None): Education and consent
p.(None): Section 49. (1) The clinical examination of a medical device may only be carried out if the test participant is informed by a doctor or dentist about the purpose,
p.(None): The importance, scope, benefits, risks and burdens of the clinical trial has been elucidated and his consent to participate in the clinical trial
p.(None): granted.
p.(None): (2) The information must be sufficiently clear and easy for the test participant to understand, so that the decision on the consent to
p.(None): Participation in the clinical trial can take place with full knowledge of the relevant facts.
p.(None): (3) The information must be given both verbally and in writing. You must clarify that a rejection is required at the clinical trial
p.(None): participate, or withdraw from the clinical trial 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 the medical consequences of leaving the
p.(None): clinical trial at certain times.
p.(None): (4) The test participants are to be informed about the purpose and scope of the collection and use of personal data. Here are the
p.(None): Test takers in particular point out that data
p.(None): 1. can be checked by the monitor, during an audit and during an inspection by the authority, and
p.(None): 2. passed on to the sponsor in pseudonymized form.
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p.(None): A representative is to be appointed. The members of the ethics committee listed in Z 1 and 2 may not at the same time clinical investigators within the scope of the
p.(None): assessing clinical trial.
p.(None): Section 59. (1) The members of the ethics committee and their deputies must be free of instructions in this function. You have any relationships with manufacturers
p.(None): or distributors of medical devices to the governor in full. They have become active in the ethics committee -
p.(None): without prejudice to any other reasons for bias - to include in all matters in which such a relationship is appropriate, their full
p.(None): To question impartiality.
p.(None): (1a) Within the framework of the organization, internal quality assurance measures are to be provided, which include in particular the regularity of the processes and
p.(None): Ensure procedures.
p.(None): (2) The implementation of the agendas of the ethics committee and the proper completion of its decisions and statements is in one
p.(None): To set down the rules of procedure in writing, which require the approval of the responsible governor.
p.(None): (3) The sponsor or clinical investigator must provide the ethics committee with all the necessary documents for assessing the clinical trial in accordance with § 43,
p.(None): in particular also evidence of qualifications, the test plan, 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 obtaining their consent and documents about the
p.(None): Submit insurance in accordance with sections 47 and 48 and compensation for the participation of the test participants.
p.(None): Section 60. (1) The responsible ethics committee shall assess in particular on the basis of the submitted documents:
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 and medical justification for the test and with regard to its
p.(None): scientific significance and assessment of the benefit / risk ratio,
p.(None): 4. Selection and recruitment of the test participants as well as clarification and obtaining the consent to participate and
p.(None): 5. the precautions necessary for the occurrence of a claim, in particular with regard to the insurance in accordance with sections 47 and 48 in connection with the
p.(None): clinical trial.
p.(None): (2) The Ethics Committee must submit its statements in writing with reference to the submitted documents. The
p.(None): A comment on a clinical trial is to be given within 60 days, and a comment on a change in the trial plan is to be given 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 can ensure the proper conduct of the clinical trial with a view to protecting the health and safety of the
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Social / employees
Searching for indicator employees:
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p.(None): Section 62. (1) The responsibilities and duties of the persons involved in the clinical trial, in particular the sponsor, clinical investigator
p.(None): and monitors must be specified in writing and confirmed by their signatures.
p.(None): (2) The sponsor may assume the function of the sponsor and that of the monitor by the sponsor if this is documented
p.(None): and the respective responsibilities and areas of responsibility are fully assumed.
p.(None): Tasks and areas of responsibility of the sponsor
p.(None): § 63. (1) The sponsor has the clinical investigator taking into account his professional quali fi cation, his availability over the entire period of the
p.(None): Study and taking into account the suitability and availability of the local, medical and medical devices available to the clinical investigator
p.(None): organizational circumstances and options.
p.(None): (2) If necessary, the sponsor must ensure appropriate monitoring of the clinical trial. He has one or more accordingly
p.(None): entrust trained and quali fi ed persons with the function of a monitor in accordance with Section 65 or their areas of responsibility and responsibilities themselves
p.(None): perceive. He must also ensure that internal audits of the study can be carried out if necessary.
p.(None): (3) The sponsor has the clinical investigator all for the safe use of the medical device to be tested and the proper implementation of the
p.(None): clinical trial documentation, including relevant information that becomes available only during the ongoing study
p.(None): to provide him with administrative support, if necessary to provide supportive research staff and if necessary for a suitable one
p.(None): Training of the clinical investigator and his employees in the intended and safe installation, preparation and use of the medical device and
p.(None): of its necessary accessories.
p.(None): (4) The sponsor has to ensure that neither the test participant nor the Austrian social insurance institutions or third parties from the
p.(None): Provision of the medical device intended for clinical testing incurs costs, unless
p.(None): 1. the use of which is associated with a primary individual benefit insofar as it serves to ward off health damage or to remedy one
p.(None): physical suffering is urgently needed and an essential one compared to available medical devices that are already permitted on the market
p.(None): Seriously increases the chances of success,
p.(None): 2. information about the medical device used and the clinical trial has been made available to the social security institution or third parties
p.(None): and
p.(None): 3. Social insurance institutions or third parties on the basis of these documents after assessing the existence of the requirements of points 1 and 2 of an application
p.(None): have agreed to the assumption of costs.
p.(None): (5) The sponsor must assess the test plan and confirm it with his signature.
p.(None): (6) The sponsor may delegate the performance of its duties or obligations in whole or in part to external scientific institutions.
p.(None): Tasks and responsibilities of the clinical investigator
p.(None): Section 64. (1) Clinical investigators may only be appropriately qualified for independent practice of the medical or dental profession in Austria
p.(None): be an authorized 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 has at least two years of experience in clinical trials
p.(None): can demonstrate.
...
p.(None): to familiarize yourself thoroughly with its intended use. The sponsor has access to all relevant data to the clinical investigator
p.(None): guarantee.
p.(None): (3) The clinical investigator must ensure that he and his staff also consider the personnel and the available
p.(None): Institutions and medical facilities 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 information and, if necessary, their information required by this federal law
p.(None): legal representative and obtaining the necessary consent.
p.(None): (4a) The clinical investigator has to fulfill the obligations for the sponsor according to Art. 13, 15, 16 and 18 of the General Data Protection Regulation and in the event of violations of the
p.(None): Protection of personal data to notify the test participant in accordance with Art. 34 of the General Data Protection Regulation and to the sponsor
p.(None): inform.
p.(None): (5) The clinical investigator has the sponsor about all medical device side effects and all serious adverse events within the scope of the
p.(None): clinical trial.
p.(None): (6) The clinical investigator must sign the study plan and confirm in writing and with his signature that he has completed the clinical study in accordance with the
p.(None): Test plan and the provisions of this federal law.
p.(None): (7) The clinical investigator has all employees who are involved in the conduct of the clinical trial or in the supervision of the trial participants,
p.(None): to provide all information relevant to them.
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 sponsor for appropriate monitoring of the clinical
p.(None): Exam to ensure
p.(None): 2. to work in accordance with the standard operating instructions (SOP), to visit the clinical investigator before, during and after the completion of the clinical trial,
p.(None): to check compliance with the test plan and to ensure that all data are correctly and completely recorded and recorded, and
p.(None): 3. Compare the entries in the test sheets with the original findings and inform the clinical investigator about errors and omissions.
p.(None): (2) The monitor must have the qualifications that enable it to provide expert support for the clinical trial.
p.(None): Section 65a. (1) The provisions of sections 39, 40 (1), 3, 4, 5 and 7, 40a and 40b, 41 to 44, 45 (2), 46 to 64 also apply to performance assessment tests,
p.(None): unless paragraph 2 specifies otherwise.
p.(None): (2) Unless a type or amount of specific sampling of
p.(None): Exam participants or additional medical exams or treatments are provided or as part of the performance evaluation exam
p.(None): Sections 47 to 54 do not apply if the in vitro examinations carried out can have diagnostic or therapeutic consequences for the test participants
p.(None): for the performance evaluation of in vitro diagnostics.
p.(None): statutory authorization
p.(None): § 66. The Federal Minister of Labor, Health and Social Affairs has, if this is in view of the clinical evaluation, the proper planning,
...
p.(None): Österreich GmbH must be proven.
p.(None): (6) When processing data in accordance with paragraphs 1 and 2, the use of the name and the area-speci fi c is for patient identification
p.(None): Personal identification number GH and AS (Section 10 Paragraph 2 E Government Act, Federal Law Gazette I No. 10/2004) permitted. The area-specific personal identifier AS may only be in
p.(None): encrypted form can be used and saved. The person responsible must delete the direct personal link irreversibly as soon as it is for
p.(None): the purposes according to paragraph 1 nos. 1 and 3 are no longer necessary.
p.(None): (7) Gesundheit Österreich GmbH is entitled to obtain information on the time and cause of death from
p.(None): To request persons whose data are processed in the register.
p.(None): (8) The managing director of Gesundheit Österreich GmbH has to ensure that the identity and role of those authorized to access the state of health at every access
p.(None): Technically proven and logged accordingly. He must ensure that the appropriate state-of-the-art technology is used
p.(None): Precautions are taken to prevent the destruction or modification of the data due to program errors (viruses), to prevent destruction,
p.(None): Prevent unauthorized users or systems from changing or querying the data in the register. Furthermore, he must ensure that everyone
p.(None): processing operations carried out, such as entries, changes, queries and transmissions in particular, are traceable. He has a
p.(None): To create a data security concept that is binding for the employees of Gesundheit Österreich GmbH.
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 access the data processed or processed in the register
p.(None): 1. basically only in pseudonymized form,
p.(None): 2. to exercise the rights of data subjects in accordance with Chapter 3 of the General Data Protection Regulation, but also in a directly personal form
p.(None): access. For scientific purposes, Gesundheit Österreich GmbH may only access in a pseudonymized form.
p.(None): (12) The health care institutions participating in the registers may
p.(None): 1. For the purposes of paragraph 1 no. 3, access all data relating to this person in the register, also in personal form, if this is within the scope
p.(None): a specific treatment situation of the respective person is required,
p.(None): a) with the express consent of the data subject, or
p.(None): (b) where consent cannot be obtained, in the vital interest of the data subject, and
p.(None): 2. access the data processed in the register in pseudonymized form for scientific purposes (para. 1 no. 6).
p.(None): (13) For purposes of medical device vigilance, the Federal Office for Safety in Health Care is entitled to access the data processed in the register
...
p.(None): (5) Personal data must be pseudonymized immediately. When processing data in accordance with paragraphs 1 and 2, only that is required for patient identification
p.(None): Use of the area-specific personal identifiers GH and AS (Section 10 (2) E-Government Act, Federal Law Gazette I No. 10/2004) permitted. The
p.(None): area-specific personal identifiers AS may only be used and saved in encrypted form. The direct personal reference is immediate
p.(None): irreversibly deleted after conversion.
p.(None): (6) The area-specific personal identifiers are to be deleted as soon as they are no longer required for the purposes set out in paragraph 1. The federal agency
p.(None): "Statistics Austria" has the Health Austria GmbH - upon 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 identity and role of the authorized user at every access
p.(None): be proven and logged according to the state of the art. He must ensure that the appropriate state of the art
p.(None): Appropriate precautions are taken to prevent the destruction or modification of the data by program errors (viruses) and to prevent
p.(None): Prevent destruction, modification or query of the data in the register by unauthorized users or systems. He must also ensure that
p.(None): all usage processes carried out, such as in particular entries, changes, queries and transmissions, are traceable. He has a
p.(None): To create a data security concept that is binding for the employees of Gesundheit Österreich GmbH.
p.(None): (9) The healthcare institutions participating in the registers may access data in the registers for scientific purposes in
p.(None): access pseudonymized form.
p.(None): (10) Any access to the data processed or to be processed in the registers by Gesundheit Österreich GmbH may only be made for the purposes of paragraph 1
p.(None): respectively.
p.(None): (11) The Federal Office for Safety in Health Care is authorized to access the data processed in the registers in pseudonymised form,
p.(None): if this is for the purpose of protecting the health and safety of patients, for warding off risks and for the purpose of medical device vigilance and
p.(None): Market surveillance is necessary.
p.(None): (12) The Managing Director of Gesundheit Österreich GmbH is obliged to give access to the individual users of Gesundheit Österreich
p.(None): GmbH individually assign. Health Austria GmbH's authorized users are aware of the provisions of the General Data Protection Regulation and the
p.(None): To teach data security concept. These access rights shall be withdrawn from their access rights if they are used to further fulfill them
p.(None): no longer need the assigned tasks or do not process the data in accordance with their intended purpose.
p.(None): (13) The managing director of Gesundheit Österreich GmbH has to ensure through organizational and technical precautions that access is granted
...
Social / gender
Searching for indicator gender:
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p.(None): Preserve with regard to the importance of the medical device for the enforcement of any liability claims.
p.(None): (2) Agreements that prevent health care facilities from fulfilling their obligations under paragraph 1 are null and 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 to ward off risks associated with
p.(None): Implantations of pacemakers, implantable defibrillators and loop recorders,
p.(None): 2. for the purpose of medical device vigilance and market surveillance in connection with pacemakers, implantable defibrillators and loop devices
p.(None): recorders,
p.(None): 3. for the purpose of quality-assured treatment in connection with the corresponding implantations,
p.(None): 4. for the purpose of quality assurance of pacemakers, implantable defibrillators and loop recorders,
p.(None): 5. for the purpose of statistics as a basis for planning, quality assurance and quality reporting in the Austrian healthcare system and
p.(None): 6. for scientific purposes
p.(None): maintain a register for pacemakers, implantable defibrillators and loop recorders. Gesundheit Österreich GmbH is responsible for the
p.(None): 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 implanting / treating facility or name of the
p.(None): treating doctor, hospital number, contact details),
p.(None): 2. Data on patient identification (name, gender, date of birth, social security number, contact details, area-speci fi c
p.(None): Personal identifiers)
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 (pre-intervention, symptoms, etiology, preoperative heart rhythm),
p.(None): 5. Technical, clinical, organizational and temporal data on the care process (surgeon, implantation data of the medical devices and the
p.(None): associated probes, date of implantation, location of medical devices, access, secondary prophylaxis),
p.(None): 6. Technical data on the implant, speci fi c implant parameters, data on the individual implant setting (model, manufacturer and serial number of the
p.(None): Medical devices and the associated probes, implant parameters), and
p.(None): 7. Technical, clinical, organizational, temporal and event-related data for aftercare (technical and clinical control data of the implanted
p.(None): Medical devices and the associated probes, functional status, date and indication of the control, complications, explant date,
p.(None): Explantationsgrund).
p.(None): (3) The implanting / treating health facilities are obliged in accordance with paragraph 4, the data types mentioned in paragraph 2 of the
p.(None): Gesundheit Österreich GmbH to be transmitted personally online.
p.(None): (4) The transmission according to paragraph 3 is only permitted if the data subjects
p.(None): 1. have been informed about the processing for the purposes of the pacemaker, ICD or loop recorder register and
p.(None): 2. have expressly consented to this processing.
p.(None): If the consent is withdrawn in the event of a follow-up contact, the person concerned must be informed that the data is directly related to a person
...
p.(None): (15) The managing director of Gesundheit Österreich GmbH must ensure through organizational and technical precautions that access is granted
p.(None): Rooms in which the database server is located can only be accessed by those with access to Health Austria GmbH.
p.(None): (16) If the database server is removed from the area of Gesundheit Österreich GmbH, the managing director of Gesundheit Österreich GmbH
p.(None): ensure that unauthorized use is excluded.
p.(None): (17) The distributors of medical devices, which are kept in the pacemaker, ICD, loop recorder register, are required for purposes
p.(None): to make the necessary technical data of your implants available 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 to ward off the risks of implantable
p.(None): Medical devices,
p.(None): 2. for the purpose of medical device vigilance and market surveillance of implantable 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 in the Austrian healthcare system and
p.(None): 5. for scientific purposes
p.(None): To maintain implant registers for active implantable medical devices, soft tissue implants, cardiovascular, 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, specific implant parameters, data on individual implant settings, and
p.(None): 7. Technical, clinical, organizational, temporal and event-related data for aftercare.
p.(None): (3) The implanting / treating healthcare facilities are, if this is to protect the health and safety of patients
p.(None): is necessary, the personal data of Gesundheit Österreich GmbH mentioned in Paragraph 2 and required for the purposes of keeping the register
p.(None): can also be submitted online. Health Austria GmbH is responsible for granting access to health care facilities
p.(None): documented in a comprehensible manner.
p.(None): (4) The Federal Minister for Health, Family and Youth has set up implant registers and the speci fi c data sets for the individual
p.(None): Specify register by regulation. This regulation also includes 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 in accordance with paragraphs 1 and 2, only that is required for patient identification
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): form a combined product, the intended main effect of which is based on the chemical composition of the medicinal product and which is used exclusively for
p.(None): Use in this compound is intended and is not reusable, so this product is subject to the Medicines Act. The Federal Office for Security in
p.(None): Health care has the basic requirements according to the II. Main part of this federal law when assessing the medical device part
p.(None): apply as far as safety and performance-related medical device functions are affected.
p.(None): (3) Does a medical device - with the exception of in vitro diagnostic medical devices - contain a substance as an integrated component, which - used separately - as a pharmaceutical in
p.(None): According to the Medicines Act and in addition to the medical device, it can have an effect on the human body
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 (5c), this medical device is also subject to it
p.(None): 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 his authorized representative in the event of the intended
p.(None): first placing a product on the market to determine whether that product fulfills one of the definitions according to § 2 Paragraphs 1 to 6 and, if necessary, via the
p.(None): Decide on the classification and classi fi cation of the medical device. The manufacturer or his authorized representative must be domiciled in Germany. in the
p.(None): As part of this procedure, it can obtain an opinion from the Delimitation and Classification Advisory Board in accordance with Section 5b.
p.(None): (2) The Federal Office for Safety in Health Care may make ex officio determinations in accordance with paragraph 1. It can also be a
p.(None): Obtain the opinion of the delimitation and classification advisory board in accordance with § 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 Health Care on issues relating to the delimitation of
p.(None): Medical devices for other products as well as for the preparation of reports on whether a product fulfills one of the definitions according to § 2 Paragraphs 1 to 6 and
p.(None): if necessary on the classification of the medical device, is an advisory board to the Federal Ministry of Health (delimitation and classification advisory board)
p.(None): to set up.
p.(None): (2) In order to clarify delimitation questions from medical devices to medicinal products, the Advisory Board pursuant to para
p.(None): (Delimitation Advisory Board) in accordance with Section 49a AMG.
p.(None): (3) The Federal Minister of Health has to appoint qualified persons as permanent members for a period of five years. In the
p.(None): Composition is to be considered that a balanced cast with regard to the delimitation and classification is considered
p.(None): upcoming products or product groups is guaranteed.
p.(None): (4) Depending on the nature of the subject to be treated, the deliberations of the Delimitation and Classification Advisory Board can be non-permanent in individual cases
p.(None): Members who are professionally qualified are involved.
p.(None): (5) The Federal Minister of Health has an employee of his ministry with the chair in the demarcation and
p.(None): Entrust 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. Representatives only have such voting rights if they are prevented from doing so
...
p.(None): 2. There are meaningful results of the required non-clinical examinations that have been carried out in accordance with the current state of science
p.(None): were.
p.(None): method
p.(None): § 40. (1) For clinical trials of medical devices, the sponsor has to do this in Appendix 6 of Directive 90/385 / EEC, in Appendix VIII of the
p.(None): Directive 93/42 / EEC, to use the procedure listed in Annex VIII of Directive 98/79 / EC for the performance evaluation of in vitro diagnostic medical devices.
p.(None): (2) With the clinical trial of active implantable medical devices in accordance with Directive 90/385 / EEC as well as class III or medical devices
p.(None): Implantable or long-term use invasive medical devices of classes IIa or IIb according to directive 93/42 / EEC can according to
p.(None): approval by the responsible ethics committee and submission of a proper report to the Federal Office for Security in the
p.(None): Health care should be started, provided the Federal Office for Health Safety does not work within a period of 60 days after the due date
p.(None): Notification of the clinical trial is the clinical trial for the protection of the trial participants, public health or due to other non-existence of the
p.(None): Prohibited the requirements of Section 41 (4) or approved the conduct of the clinical trial before this deadline.
p.(None): (3) With the clinical trial of medical devices in accordance with Directive 93/42 / EEC, which are not mentioned in paragraphs 2 and 5, and the
p.(None): Performance assessment tests of in vitro diagnostic medical devices according to directive 98/79 / EG, which are not mentioned in paragraph 5, can be carried out after a favorable opinion
p.(None): be started by the responsible ethics committee and reporting a proper report to the Federal Office for Safety in Health Care.
p.(None): (4) The notification to the Federal Office for Safety in Health Care has, including the declaration mentioned in the annexes in paragraph 1
p.(None): to take place. The documentation listed there must be made available immediately upon request.
p.(None): (5) With the clinical testing of medical devices in accordance with Directive 93/42 / EEC, which carry the CE marking in accordance with Section 15, the clinical
p.(None): Testing does not have a purpose of the medical device other than that provided for in the conformity assessment and the clinical trial
p.(None): no additional diagnostic or therapeutic measures are necessary - after a positive opinion from the responsible ethics committee
p.(None): be started. With the performance evaluation test of in vitro diagnostic medical devices according to the directive 98/79 / EG, which carry the CE marking according to § 15
p.(None): - provided that the performance assessment test does not serve any other purpose of the in vitro diagnostic medical device than the one intended in the conformity assessment
p.(None): The subject has to be started - after a favorable opinion has been given by the responsible ethics committee. Section 47 does not apply.
p.(None): (6) The sponsor has given the Federal Office for Safety in Health Care and the competent authorities of other parties to the EEA contract
p.(None): Completion of the clinical trial, in the event of early termination, with a justification, to be reported. This message also sent to the
p.(None): competent authorities of all other EEA contracting parties and the European Commission to take place if the early termination comes from
p.(None): Security reasons. The final report in accordance with section 2.3.7 of Annex 7 to Directive 90/385 / EEC or section 2.3.7 of Annex X to
p.(None): Directive 93/42 / EEC is for the Federal Office for Safety in Health Care and the competent authorities of the other contracting parties to the EEA
p.(None): ready injury.
p.(None): (7) Reports in accordance with paragraphs 1, 2, 3 and 6, § 40b and § 42 paragraph 8 must be in accordance with a regulation in accordance with § 67 by means of the European database for
p.(None): Medical devices are made.
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 change is significant and specifically affects the
p.(None): The sponsor has to influence the safety of the trial participants or influence the scientific significance of the clinical trial
p.(None): Examinations in accordance with section 40 (2) and (3) of the Federal Office for Safety in Health Care and the responsible ethics committee check the content of the change and
...
p.(None): according to paragraph 1.
p.(None): (5) Without prejudice to paragraphs 1 to 4, the sponsor and the clinical investigator have to deal with any new circumstance regarding the course of the examination or
p.(None): Development of a clinical trial medical device that can compromise the safety of subjects or users of the urgently needed
p.(None): Take security measures to protect test takers or users from immediate danger. You followed up on clinical trials
p.(None): Section 40 (2) and (3) immediately the Federal Office for Safety in Health Care and the responsible ethics committee about these new circumstances and the
p.(None): measures taken to inform. In the case of clinical trials in accordance with Section 40 (5), they immediately have the responsible ethics committee about these new ones
p.(None): To inform about the circumstances and the measures taken. The notification requirements according to § 70 remain unaffected.
p.(None): Suspension or prohibition of the clinical trial
p.(None): Section 40b. (1) If the Federal Office for Safety in Health Care has objective reasons to assume that the requirements for the notification in accordance with § 40
p.(None): Paragraphs 2 and 3 are no longer given, or has information that relates to the safety or the scientific basis of a clinical
p.(None): If the exam raises concerns, it must suspend or prohibit the clinical trial. Before the decision, except in the case of danger (§ 57 des
p.(None): AVG), to hear the sponsor and to inform the clinical investigator. The sponsor must give his opinion within one week.
p.(None): (2) The Federal Office for Safety in Health Care, if it suspends or prohibits the conduct of a clinical trial, the others
p.(None): Contracting parties of the EEA, the responsible ethics committee, and the European Commission, stating the reasons for its decision, the clinical
p.(None): Suspend or prohibit examination, inform. The Federal Office for Health Safety has made a major change to a clinical
p.(None): Ordered, it has the other contracting parties of the EEA, in whose territory the clinical trial is carried out, as well as the competent
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 or the clinical investigator or anyone else at the
p.(None): clinical trial participants no longer fulfilled their obligations, 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 also applies if the clinical trial is already
p.(None): has ended. Reporting obligations according to paragraph 2 remain unaffected.
p.(None): general requirements
p.(None): Section 41. (1) When planning, setting up and conducting clinical trials, the health risks and burdens for the trial participants are so
p.(None): to keep it as low as possible.
p.(None): (2) The clinical trial of medical devices may only be carried out if the risks associated with it for the trial participants
p.(None): measured by the expected significance of the result of the test for medicine and the risk of impairment that cannot be ruled out
...
p.(None): Science fulfilled professionally.
p.(None): (5) Ethics committees are obliged to provide the Federal Office for Safety in Health Care with all information and to send documents that
p.(None): this is required to perform its duties under this section.
p.(None): (6) If an inspection determines that a clinical trial is being carried out in contravention of the provisions of this Federal Act, or will arise
p.(None): Concerns about the safety or the scientific basis of the clinical trial and will affect the life or health of
p.(None): Exam participants or users are at risk, the Federal Office for Safety in Health Care can take measures within the meaning of Section 40b (1) without
p.(None): previous procedure or before issuing a decision; however, written notification of this must be issued within two weeks,
p.(None): otherwise the measure is deemed to be canceled.
p.(None): (7) If the Federal Office for Safety in Health Care incurs cash expenses during the inspection of a clinical trial, these are the sponsor
p.(None): to be invoiced, unless the clinical investigator performs the sponsor's duties within the meaning of Section 3 (5).
p.(None): ethics committees
p.(None): Section 57. (1) The clinical examination of a medical device may only be carried out if the assessment has been carried out by the responsible ethics committee
p.(None): has been caught up.
p.(None): (2) Within the framework of a multicenter examination, a responsible ethics committee can comment on the opinion of another person responsible for this clinical examination
p.(None): Declare ethics committee sufficient. In this case, the assessing ethics committee must also announce all involved auditors and all
p.(None): Documents are made available that provide an assessment with regard to their professional quali fi cation and experience as well as the existing facilities
p.(None): and allow the staff.
p.(None): § 58. (1) With regard to clinical trials outside of hospitals, the governor must ensure that in the area of his
p.(None): A sufficient number of independent state ethics committees are set up to perform the tasks set out in Section 60.
p.(None): (2) For the clinical examination at hospitals, the responsible ethics committee in accordance with Section 8c of the Hospitals Act, Federal Law Gazette No. 1/1957.
p.(None): (3) The appointment of ethics committees in accordance with paragraph 1 is to the Federal Ministry of Health and Women and the Federal Office for Security in the
p.(None): 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,
...
General/Other / Dependent
Searching for indicator dependent:
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p.(None): (1a) “Subcategory of medical devices” is a group of medical devices that are to be used in the same areas or with the same
p.(None): Technologies.
p.(None): (1b) “Generic product group” is a group of medical devices with the same or similar usage regulations or with technological ones
p.(None): Similarities so that they can be generally classified without taking into account specific characteristics.
p.(None): (1c) "Disposable product" is a medical device that is intended for single use by a single person.
p.(None): (2) "Accessories" for a medical device are objects, substances, preparations made of substances and software that are not themselves medical devices according to paragraph 1,
p.(None): but are intended according to their intended purpose expressly defined by the manufacturer,
p.(None): 1. to be used together with a medical device, so that it corresponds to the one specified by the manufacturer of the medical device
p.(None): Purpose of the medical device can be used, 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 implantable medical devices. Accessories for an in-
p.(None): Vitro Diagnostic is itself an In Vitro Diagnostic, unless it is an invasive product intended for taking samples as well
p.(None): Products that come into direct contact with the human body for the purpose of sampling. These are considered medical devices in the sense of
p.(None): Directive 93/42 / EEC.
p.(None): (3) "Active medical device" is any medical device, the operation of which is dependent on an electrical energy source or another energy source than
p.(None): the energy generated directly by the human body or by gravity. A medical device that is used to transmit energy, shock or
p.(None): Parameters between an active medical device and the patient is used without a significant change in energy, shock or
p.(None): Parameters does not count as an active medical device.
p.(None): (4) “Active implantable medical device” is any medical device that operates on an electrical energy source or an energy source other than that
p.(None): is directly dependent on the energy generated by the human body or gravity, and is designed to be wholly or partly by one
p.(None): surgical or other medical intervention in the human body or by a medical intervention in a natural body opening
p.(None): and is intended to remain there after the procedure.
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): used for the in vitro examination of samples from the human body, including blood and tissue donations, and
p.(None): 2. serves solely or predominantly to
p.(None): (a) provide information about physiological or pathological conditions or congenital anomalies, 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, which are specifically designed for in-vitro analysis from the manufacturer by the manufacturer are also considered to be in-vitro diagnostics
p.(None): human body samples are intended as a primary container for storage. Products for general laboratory needs are not considered
p.(None): Vitro diagnostics, unless, due to their characteristics, they are intended for in vitro investigations in accordance with their intended purpose specified by the manufacturer
p.(None): to use the Z 2.
p.(None): (5a) "In vitro diagnostic medical device for personal use" is any in vitro diagnostic medical device that is designed according to the intended purpose of the layperson in the
p.(None): home environment can be applied.
...
General/Other / Natural Hazards
Searching for indicator hazard:
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p.(None): Maintain, convert, assemble, adapt or process commercially, clean, disinfect or professionally or professionally clean medical devices
p.(None): sterilize or use or operate the medical devices in healthcare facilities are subject to the following with regard to these activities
p.(None): Monitoring.
p.(None): (2) Monitoring within the meaning of paragraph 1 is carried out by the organs of the Federal Office for Safety in Health Care, the Federal Minister for
p.(None): Health and women or by experts commissioned by them. The activity of relevant accredited bodies, from
p.(None): Federal Minister of Health and Women recognized organizer of proficiency tests, operators of medical device registers or other organizers
p.(None): supra-regional comparative tests and assessments in connection with medical devices recognized by the Federal Minister of Health and Women
p.(None): be included.
p.(None): (3) Insofar as monitoring is provided within the scope of conformity assessment procedures in accordance with an ordinance pursuant to Section 28, this is carried out by
p.(None): the relevant notified body responsible for the conformity assessment procedure. Monitoring by notified bodies is carried out in accordance with a regulation
p.(None): § 28.
p.(None): (4) The monitoring according to Paragraph 1 can relate to all aspects relating to the safety, functionality and quality of medical devices as well as the
p.(None): Protect the safety and health of patients, users or third parties.
p.(None): (5) The monitoring of health care facilities can be systematic, taking into account the respective hazard potential,
p.(None): carried out on a random basis or in the event of an incident, in particular with regard to possible dangers to the life or health of patients or users
p.(None): or third parties in connection with medical devices or with a view to ensuring quality-assured availability, use and
p.(None): Maintenance of medical devices in the interest of health. Is there a violation of provisions of this federal law or on the basis thereof
p.(None): decrees, the institution must be instructed to remedy the defects within a reasonable period of time. Comes in surveillance
p.(None): that a violation of provisions of this federal law or on the basis of ordinances issued on it
p.(None): Health of patients, users or third parties is endangered, so are the necessary measures to protect the life and health of these
p.(None): Meet people.
p.(None): (6) The monitoring of facilities and establishments, which of establishments, facilities or persons within the meaning of paragraph 1 with the storage and the
p.(None): Transport of medical devices has only been commissioned if circumstances exist that justify the assumption that medical devices are stored
p.(None): or the means of transport are used for other purposes than storage facilities beyond the time required to complete the transport agenda.
p.(None): (7) The organs of the Federal Office for Safety in Health Care, the Federal Ministry for Health and Women and those pursuant to para. 2
p.(None): commissioned experts are authorized to
p.(None): 1.On entering and inspecting real estate, business premises, business premises, means of transport in or on which an activity has been carried out in accordance with paragraph 1
p.(None): becomes,
p.(None): 2. to inspect and test medical devices, especially to put them into operation and to take samples,
...
p.(None): № L 262 of July 27, 1976, issued national regulations until December 31, 1994, may be placed on the market and in June 30, 2004
p.(None): Be put into operation.
p.(None): (6) Medical devices that are in operation in healthcare facilities at the time this Federal Act comes into force or that are used for
p.(None): Application are kept available, may continue to be operated or used there, unless they indicate with regard to their safety or performance
p.(None): Defects that could endanger patients, users or third parties.
p.(None): (7) Companies, facilities or persons within the meaning of § 67 Paragraphs 1, 3 and 4 who already carry out their work when this Federal Act comes into force
p.(None): to comply with the reporting obligation pursuant to Section 67 by 1 March 1997 at the latest.
p.(None): (8) Assessments by ethics committees that are pending when this federal law comes into force are by the ethics committees
p.(None): to complete in its previous composition.
p.(None): (9) Medical devices with derivatives from human blood that comply with the regulations that were in force in Austria on January 10, 2002
p.(None): will be placed on the Austrian market until the end of January 10, 2007. Medical products with derivatives placed on the market in this way
p.(None): human blood may continue to be placed on the market or put into operation in Austria until the end of January 10, 2009, unless the
p.(None): Requirements according to §§ 8 and 9 are not met or measures according to § 77 are taken. Changes to these regulations are in each case
p.(None): Use purposes of protecting human beings from an immediate or indirect health hazard.
p.(None): § 113. Insofar as this federal law refers to provisions of other federal laws, these provisions are in their currently applicable version
p.(None): apply.
p.(None): Come into effect
p.(None): Section 114. (1) This Federal Act comes into force one month after the first day of the month following its announcement.
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 paragraph 5a and 5b, § 2 paragraph 6, § 2 paragraph 8a, § 2 paragraph 10 line 1, § 2 paragraph 11, § 2 paragraph 15, the heading to § 3, Section 3 (2a), Section 3
p.(None): Paragraph 3a, § 3 Paragraph 7a, § 3 Paragraph 14a, § 9 Paragraph 2 and 3, § 9 Paragraph 5, § 11 Paragraph 4, § 13 Paragraph 1a, § 15 Paragraph 1, § 18 Paragraph 1, Section 19 Paragraph 1, Section 21, Section 27, Section 28 Paragraph 2 Nos 7 to 9,
p.(None): Section 29 (2), Section 29 (5), Section 29 (7), Section 31, Section 33, Section 34, Section 37 (9) to (11), Section 65a, Section 66, Section 111 Z 2a, Section 111 Z 13a , Section 112 (4a) of this Federal Act, in which
p.(None): Version of the Federal Law BGBl. I No. 117/1999 come into force on June 7, 2000.
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, section 67 subsections 1 to 3, section 76 subsection 2, section 77 subsection 3, section 111 line 19a,
p.(None): Section 112 (1) and (2), Section 113, Section 116a, Section 117 (1) (2) of this Federal Act as amended by Federal Law BGBl. I No. 117/1999 shall come into force on December 7, 1999
p.(None): in force.
p.(None): (5) § 104 and § 111a in the version of the Federal Law BGBl. I № 33/2002 occur one month after the announcement of the Federal Law BGBl. I
p.(None): No. 33/2002 following the first day of the month.
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of science.
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 a significant extension of the scientific understanding of the condition, the illness or the disorder of the minor
p.(None): aims and can thereby benefit either the patient or the patient group to which the minor belongs, and
p.(None): 2. the clinical trial brings minimal risk and burden to the minor; a clinical trial shows a minimal
p.(None): Risk and a minimal burden, if it can be expected that they lead to a minor and only temporary impairment
p.(None): and any symptoms or inconveniences may be very minor and will only occur temporarily.
p.(None): § 52. The clinical trial may be carried out on a person who is suffering from a mental illness or a comparable impairment of their
p.(None): Ability to make decisions has a legal representative or has been stopped by judicial or official order or in accordance with the Accommodation Act,
p.(None): BGBl. No. 155/1990, is not carried out.
p.(None): Section 52a. (1) A clinical trial of its kind can only be used in emergency situations in which, within a reasonable time, no consent of the legal representative
p.(None): can be obtained, a clinical trial can then be performed on a person who is unable to consent,
p.(None): if
p.(None): 1. There are no indications that either the patient refused or would refuse the clinical trial or that the requirements of the
p.(None): § 52 exist,
p.(None): 2. Such research for the validation of data used in clinical trials on persons capable of obtaining informed consent or by means of
p.(None): other research methods have been obtained and are essential 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 is intended to fulfill an intended purpose within the meaning of Section 2 (1) nos. 1 to 3 in an emergency situation,
p.(None): 4. The application of the medical device that is being tested, based on the knowledge of medical science, is indicated to the emergency patient
p.(None): a) to recognize, prevent, monitor, treat or alleviate an illness,
p.(None): (b) identify, monitor, treat, alleviate or compensate for an injury or disability, or
p.(None): c) to examine, change or replace the anatomical structure or physiological processes,
p.(None): and the benefit to the patient associated with inclusion in the clinical trial outweighs the risk
p.(None): 5. the conduct of the test and the test plan by an ethics committee that has knowledge in the field of the disease concerned, in relation to the
p.(None): EmergencyXsituation and the affected patient group or who are in clinical and ethical questions in the field of the disease in question
p.(None): With regard to the emergency situation and the affected patient group, advice was given, specifically for the conduct of clinical trials in emergency situations
p.(None): to persons who are unable to give their personal consent, and
p.(None): 6. In case of doubt, the patient's interests always outweigh the public and scientific interests.
p.(None): (2) The test center at which a clinical test is carried out in emergency situations on persons who are unable to give consent is the
p.(None): To inform the public about this in an appropriate manner.
p.(None): (3) If the patient gains the consent, he must be informed immediately that a clinical trial in an emergency situation is on him
p.(None): was or will be carried out. It must be clarified in the sense of Sections 49 and 50. 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. Further processing of the data processed up to that point requires the
p.(None): express consent under data protection law.
p.(None): (4) As soon as the consent can be obtained from the legal representative, a continuation of the clinical trial is only under the conditions
p.(None): of § 51 permitted.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, the data processed up to that point may be used for the purposes of this clinical
p.(None): Testing can be used.
p.(None): Section 53. The clinical trial of a medical device may only be carried out on a pregnant or breastfeeding mother if
...
p.(None): have agreed to the assumption of costs.
p.(None): (5) The sponsor must assess the test plan and confirm it with his signature.
p.(None): (6) The sponsor may delegate the performance of its duties or obligations in whole or in part to external scientific institutions.
p.(None): Tasks and responsibilities of the clinical investigator
p.(None): Section 64. (1) Clinical investigators may only be appropriately qualified for independent practice of the medical or dental profession in Austria
p.(None): be an authorized 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 has at least two years of experience in clinical trials
p.(None): can demonstrate.
p.(None): (2) Before the start of the clinical trial, the clinical investigator has to deal with all relevant data and documents, in particular with regard to the study plan, the
p.(None): relevant scientific literature, the preclinical data, the results of previous clinical trials with the medical device, the evidence of the
p.(None): Technical safety, the documents on the structure, composition, functionality, properties and performance of the medical device and the instructions
p.(None): to familiarize yourself thoroughly with its intended use. The sponsor has access to all relevant data to the clinical investigator
p.(None): guarantee.
p.(None): (3) The clinical investigator must ensure that he and his staff also consider the personnel and the available
p.(None): Institutions and medical facilities 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 information and, if necessary, their information required by this federal law
p.(None): legal representative and obtaining the necessary consent.
p.(None): (4a) The clinical investigator has to fulfill the obligations for the sponsor according to Art. 13, 15, 16 and 18 of the General Data Protection Regulation and in the event of violations of the
p.(None): Protection of personal data to notify the test participant in accordance with Art. 34 of the General Data Protection Regulation and to the sponsor
p.(None): inform.
p.(None): (5) The clinical investigator has the sponsor about all medical device side effects and all serious adverse events within the scope of the
p.(None): clinical trial.
p.(None): (6) The clinical investigator must sign the study plan and confirm in writing and with his signature that he has completed the clinical study in accordance with the
p.(None): Test plan and the provisions of this federal law.
p.(None): (7) The clinical investigator has all employees who are involved in the conduct of the clinical trial or in the supervision of the trial participants,
p.(None): to provide all information relevant to them.
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 sponsor for appropriate monitoring of the clinical
p.(None): Exam to ensure
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General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): In vitro diagnostic agent participates.
p.(None): (9) “Ethics Committee” is an independent body composed of medical experts and others in accordance with Section 58 (4)
p.(None): Members whose job it is to assess whether there is a scientifically sound clinical trial and whether the safety of that
p.(None): Wellbeing, the rights and integrity of test takers are protected.
p.(None): (10) "Final report of the clinical trial" or "Final report" is a complete description and evaluation of the clinical trial after its
p.(None): Termination.
p.(None): (11) “Multi-center trial” is a clinical trial that follows a single clinical trial schedule but at multiple sites
p.(None): is carried out.
p.(None): (12) “Case report scheme” or “test sheet” is a set of documents that are designed so that all relevant patient and medical device related
p.(None): Data that are required by the clinical trial plan are fully documented.
p.(None): (13) "Audit" is the comparison of the raw data and the related records with the interim or final report to determine whether the
p.(None): Raw data was reported and evaluated correctly and the clinical trial was conducted in accordance with the study plan. An audit must either
p.(None): by an internal sponsor unit that operates independently of the unit responsible for clinical research, or by an external unit
p.(None): scientific institution.
p.(None): (14) "Inspection of a clinical trial" is carried out by the responsible ethics committee, the Federal Office for Safety in Health Care
p.(None): this commissioned expert or a check carried out by a foreign health authority at the test center or at the sponsor who
p.(None): Compliance with the provisions of this federal law or other regulations on the clinical trial of medical devices checked.
p.(None): (14a) "Inspection of a performance assessment test" is one commissioned by the Federal Office for Safety in Health Care
p.(None): Experts or by a foreign health authority review of a performance assessment test that compliance
p.(None): Regulations of this federal law or other regulations on the performance evaluation of in vitro diagnostics checked.
p.(None): (15) “Adverse event” means any adverse clinical event in a subject included in a clinical trial, independent
p.(None): whether it is related to the tested or performance-rated medical device or not.
p.(None): (16) An event or a side effect within the meaning of Section 2 (17) that is fatal or life-threatening is to be classified as serious
p.(None): Causes damage or requires inpatient treatment or an extension of the inpatient stay. Any undesirable event or any
p.(None): Medical device side effect that causes damage to a fetus, its death or a congenital malformation, or the appearance of a malignant
p.(None): In any case, tumors are classified as serious.
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 deciding whether a product is under the
p.(None): AMG or falls under this federal law, in particular due to the main mode of operation of the product,
p.(None): 2. cosmetic products within the meaning of § 5 of the Food Act 1975, Federal Law Gazette № 86, (note: from 21.1.2006: food safety and
p.(None): Consumer Protection Act - LMSVG, Federal Law Gazette I No. 13/2006)
p.(None): 3. human blood, blood products, blood plasma or blood cells of human origin or products at the time of placing on the market
...
p.(None): To adequately replace additional costs for own insurance or suitable insurance for the benefit of the clinical investigator
p.(None): complete.
p.(None): Education and consent
p.(None): Section 49. (1) The clinical examination of a medical device may only be carried out if the test participant is informed by a doctor or dentist about the purpose,
p.(None): The importance, scope, benefits, risks and burdens of the clinical trial has been elucidated and his consent to participate in the clinical trial
p.(None): granted.
p.(None): (2) The information must be sufficiently clear and easy for the test participant to understand, so that the decision on the consent to
p.(None): Participation in the clinical trial can take place with full knowledge of the relevant facts.
p.(None): (3) The information must be given both verbally and in writing. You must clarify that a rejection is required at the clinical trial
p.(None): participate, or withdraw from the clinical trial 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 the medical consequences of leaving the
p.(None): clinical trial at certain times.
p.(None): (4) The test participants are to be informed about the purpose and scope of the collection and use of personal data. Here are the
p.(None): Test takers in particular point out that data
p.(None): 1. can be checked by the monitor, during an audit and during an inspection by the authority, 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 paragraph 1, the express data protection consent must also be obtained. The
p.(None): Withdrawal of consent has no effect on activities which, based on consent, have already been carried out prior to its revocation
p.(None): or the use of the data collected on this basis. The right under Article 17 of the General Data Protection Regulation is excluded.
p.(None): This must be clarified in the course of obtaining consent.
p.(None): (6) For further processing in accordance with Art. 9 Para. 2 lit. j of the General Data Protection Regulation, Section 2d (3) of the Research Organization Act, Federal Law Gazette I applies
p.(None): No. 131/2015.
p.(None): § 50. (1) If a test participant agrees to participate after comprehensive information, his consent must be recorded in writing
p.(None): become. The consent must be dated and given with the signature of the test participant. If the test participant is unable to do so
p.(None): , the consent must be given to a witness who has to confirm the consent with his signature.
...
p.(None): clinical trial data.
p.(None): (3) The study plan, the final report and all data and documents created in connection with the clinical study are for specific periods
p.(None): after completion or termination of the clinical trial, which the Federal Minister of Health and Consumer Protection issues in a regulation
p.(None): Section 66 are to be laid down. This regulation also specifies who is responsible for keeping certain data or documents.
p.(None): (3a) For the period of the retention periods, the right according to Art. 17 General Data Protection Regulation is excluded.
p.(None): (4) All data and documents relevant to the clinical trial must be submitted to the Federal Office for Safety in Health Care upon request
p.(None): Verification of compliance with the provisions of this federal law on clinical trials are made available.
p.(None): Quality control and quality management
p.(None): Section 56. (1) The sponsor and the clinical investigator have an adequate view of the planning, implementation and evaluation of a clinical trial
p.(None): System of quality management to apply, the complete traceability of all observations and findings, the correct collection and
p.(None): Processing of data and the correct derivation of conclusions guaranteed.
p.(None): (2) An audit initiated by the sponsor must be carried out by bodies or organizational units that are independent of those for the clinical trial
p.(None): Are responsible.
p.(None): (3) Test centers, facilities including laboratories as well as any kind of data are for a review by the responsible ethics committee and for
p.(None): an inspection by the Federal Office for Safety in Health Care or by a foreign health authority is available after prior notice
p.(None): do.
p.(None): (4) The aim of an inspection is to determine, by means of an objective, independent review, whether the standard prescribed in this federal law
p.(None): with regard to the planning, implementation and evaluation of clinical trials. 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 duties in accordance with this federal law in accordance with the status of
p.(None): Science fulfilled professionally.
p.(None): (5) Ethics committees are obliged to provide the Federal Office for Safety in Health Care with all information and to send documents that
p.(None): this is required to perform its duties under this section.
p.(None): (6) If an inspection determines that a clinical trial is being carried out in contravention of the provisions of this Federal Act, or will arise
p.(None): Concerns about the safety or the scientific basis of the clinical trial and will affect the life or health of
p.(None): Exam participants or users are at risk, the Federal Office for Safety in Health Care can take measures within the meaning of Section 40b (1) without
p.(None): previous procedure or before issuing a decision; however, written notification of this must be issued within two weeks,
p.(None): otherwise the measure is deemed to be canceled.
p.(None): (7) If the Federal Office for Safety in Health Care incurs cash expenses during the inspection of a clinical trial, these are the sponsor
p.(None): to be invoiced, unless the clinical investigator performs the sponsor's duties within the meaning of Section 3 (5).
...
p.(None): to support the fulfillment of their tasks. You are required to make the premises, medical devices and records available to them
p.(None): to allow prescribed or officially ordered testing, to provide the necessary staff and aids for this, and to provide the information and
p.(None): to submit the documents necessary for the performance of the tasks of the bodies responsible for monitoring or of the experts commissioned in accordance with paragraph 2
p.(None): required are.
p.(None): (9) The official acts in accordance with paragraphs 5 to 8 are, except in the event of imminent danger or if there is a reasonable assumption that the effectiveness of the
p.(None): Official action is impaired to perform during the operating hours and to announce beforehand. The organs and the experts according to paragraph 2 have
p.(None): in the course of their surveillance, taking care that any disruption or hindrance to the activities of undertakings which is not absolutely
p.(None): Facilities or persons in accordance with paragraph 1 is avoided.
p.(None): (10) The Federal Minister of Health and Women has from the point of view of an expedient and effective control for the following
p.(None): To issue a directive on the implementation of the inspections (inspection plan) during the calendar year. 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 March 31 of the following calendar year on enforcement
p.(None): to report.
p.(None): (11) Market surveillance authority within the meaning of Regulation (EC) № 765/2008 of the European Parliament and of the Council of 9 July 2008 on the
p.(None): Regulations for accreditation and market surveillance in connection with the marketing of products and repealing the regulation (EEC)
p.(None): No. 339/93 for products within the meaning of this federal law is the Federal Office for Safety in Health Care.
p.(None): (12) The Federal Office for Safety in Health Care has in accordance with the requirements of the Federal Ministry of Health
p.(None): Develop market surveillance programs for medical devices and regularly update and implement them. These are the Federal Minister for
p.(None): Submit health for approval. The Federal Office for Safety in Healthcare has these programs in the other Member States and the
p.(None): To be communicated to the European Commission and made available to the public by electronic means of communication and, if necessary, by other means
p.(None): put.
p.(None): (13) The Federal Ministry of Health operates the market surveillance activities of the Federal Office for Safety in Health Care
p.(None): Check and evaluate regularly, but at least every four years. The results of these reviews are the other Member States and the
p.(None): To be communicated to the European Commission and made accessible to the public by electronic means of communication and, if necessary, other means
p.(None): do.
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, facilities or persons who carry out testing, monitoring and certi fi cation activities
p.(None): carry out according to this federal law.
p.(None): (2) Insofar as the bodies or facilities in accordance with Paragraph 1 are accredited bodies within the meaning of the Accreditation Act, the
...
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, 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, the manufacture, the placing on the market, the distribution, the
p.(None): Erection, commissioning, maintenance, operation, application, clinical evaluation and testing, monitoring and sterilization,
p.(None): Disinfection and cleaning of medical devices and their accessories as well as averting risks and quality management when dealing with
p.(None): 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, apparatus, devices, software, materials or other used individually or connected
p.(None): Items, including those specifically designed by the manufacturer for use in diagnostic or therapeutic purposes, and for being in good condition
p.(None): Functioning of the software used by the medical device, which are intended for use by humans for the following purposes:
p.(None): 1. detection, prevention, monitoring, treatment or relief of diseases,
p.(None): 2. detection, monitoring, treatment, alleviation or compensation of injuries or disabilities,
p.(None): 3. Examination, change or to replace the anatomical structure or physiological processes or
p.(None): 4. Conception regulation
p.(None): and their intended main effect in or on the human body neither by pharmacological or immunological means nor metabolically
p.(None): is achieved, but the mode of action can be supported by such means. A new, reprocessed medical device is equivalent to the new one.
p.(None): (1a) “Subcategory of medical devices” is a group of medical devices that are to be used in the same areas or with the same
...
p.(None): endangers the safety of users or third parties if they are used under the intended conditions and for the intended purposes. any
p.(None): Risks and side effects that can occur with the intended installation, implantation or application must be taken into account
p.(None): Effectiveness of medical devices according to the state of the medical sciences and technology to be justifiable and protection of health and safety
p.(None): must be guaranteed.
p.(None): (2) Medical devices must be designed, manufactured and packaged in such a way that they are suitable for the medical services specified by the manufacturer
p.(None): according to § 2 paragraph 1 or 5, if they are exposed to loads that are normal and under the conditions provided by the manufacturer
p.(None): Transport and storage conditions can occur.
p.(None): (3) The design and construction of medical devices must take into account the generally recognized state of science and technology
p.(None): according to the principles of integrated security. When choosing the most appropriate solutions for design and construction are given in the
p.(None): Order to apply the following principles:
p.(None): 1. Elimination or minimization of risks by integrating the safety concept into the development and construction of the medical device,
p.(None): 2. if necessary, taking appropriate protection and alarm devices against risks that cannot be eliminated from the design point of view,
p.(None): 3. Educate users about the residual risks for which no adequate protective measures can be taken.
p.(None): (4) Medical devices in accordance with Section 4a (1) must also meet the relevant basic health and safety requirements of Directive 89/686 / EEC
p.(None): fulfill.
p.(None): (5) If there is a relevant risk with medical devices within the meaning of Section 4a (2), these must also meet the basic health and safety requirements
p.(None): Safety requirements in accordance with Annex I to Directive 2006/42 / EC comply, provided that these meet basic health and safety requirements
p.(None): are more specific than the basic requirements according to the respective Annexes I of the Directives 90/385 / EEC or 93/42 / EEC.
p.(None): § 9. (1) Each medical device must be accompanied by information that takes into account the level of training and knowledge of the intended
p.(None): User group for the safe use of the medical device are required. This information must include information in the label and after
p.(None): In accordance with paragraph 3 such exist in the instructions for use.
p.(None): (2) The information required for safe use must be on the medical device itself, on the package and, if applicable, on the
p.(None): Commercial packaging must be specified. If individual packaging is not possible, the information must appear on the accompanying information. The Federal Minister
p.(None): for work, health and social issues can be found in the regulation pursuant to § 10 in accordance with Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC with regard to the
p.(None): Practicability and adequacy of the attachment or provision of this information and to ensure the safe use of
p.(None): Provide exceptions for medical devices.
p.(None): (3) Each medical device must be accompanied by instructions for use in its packaging. Instructions for use are for medical devices
p.(None): Class I and Class IIa within the meaning of Directive 93/42 / EEC or for in vitro diagnostics within the meaning of Directive 98/79 / EC in duly justified cases
p.(None): not necessary if the correct and safe use of the medical device is guaranteed without instructions for use.
...
p.(None): (3) The person or facility that manufactures or places the medical device on the market has the costs of monitoring, testing or other costs
p.(None): To take measures in accordance with paragraph 2 if the CE marking has been incorrectly affixed or is missing in violation of this federal law.
p.(None): § 23. (1) The Federal Office for Safety in Health Care determines that the CE marking has been incorrectly affixed or in violation
p.(None): This federal law is missing or evidence according to § 15 paragraph 2 has not been provided within a reasonable period of time, so is the manufacturer or his
p.(None): Authorized representative, without prejudice to Section 77, is obliged to notify the further violation under the Federal Office for Safety in Health Care
p.(None): prevent specified conditions.
p.(None): (2) If the conditions in accordance with paragraph 1 are not met, the Federal Office for Safety in Health Care has all in accordance with the procedure in Section 77
p.(None): take appropriate measures to restrict or prohibit the placing on the market of the product concerned or to ensure that it
p.(None): is withdrawn from the market. The manufacturer or his authorized representative must immediately follow these measures.
p.(None): § 24. Is a medical device or other product that does not comply with this federal law unlawfully with the CE marking in accordance with
p.(None): provided this federal law, the Federal Minister of Labor, Health and Social Affairs has to the person who affixed the CE marking,
p.(None): without prejudice to Section 77, to take the necessary measures to restore the correct condition and to take them in accordance with Directives 90/385 / EEC,
p.(None): 93/42 / EEC and 98/79 / EC.
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, by ordinance with regard to the intended purpose, the technology used
p.(None): and the place, type and duration of application of the medical devices, taking into account the relevant legal acts of the European Communities
p.(None): 1. to determine the classes to which medical devices can be assigned, particularly with regard to conformity assessment, 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): § 26. Exists between a manufacturer and a notified body within the scope of this federal law within the framework of a
p.(None): Conformity assessment procedure with regard to the classification of a medical device based on the classification rules according to an ordinance according to § 25
p.(None): If there is no agreement, the notified body must apply for the decision of the Federal Office for Safety in Health Care.
p.(None): European delimitation, classification and derogation clause
p.(None): Section 26a. Is the Federal Minister of Health after referral to the Advisory Board in accordance with § 5b of the statement that according to the technical progress and the
p.(None): due to the information available in § 70, an 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 ask them to take the necessary measures to adapt the
p.(None): To adopt classification rules.
p.(None): § 26b. The Federal Minister of Health must submit a sufficiently reasoned application to the European Commission and request that the
p.(None): take the necessary measures if, after referral to the Advisory Board in accordance with § 5b, he considers that
p.(None): 1. the application of the classification rules in accordance with Annex IX to Directive 93/42 / EEC a decision on the classification of a particular one
p.(None): Medical device or a specific category of medical device, or
p.(None): 2. a specific medical device or a specific series deviating from the provisions in Annex IX of Directive 93/42 / EEC into another
p.(None): Class is to be classified, or
p.(None): 3. the conformity of a medical device or a series deviating from Article 11 of Directive 93/42 / EEC or deviating from Article 9 of the
p.(None): Directive 90/385 / EEC is to be determined in the exclusive application of a certain procedure, which results from the in Article 11 of the
p.(None): Directive 93/42 / EEC or from the procedures provided for in Article 9 of Directive 90/385 / EEC, or
p.(None): 4. A decision is required as to whether a certain product or a certain product group falls under one of the basic provisions in Article 1
p.(None): Paragraph 2 lit. a to e of Directive 93/42 / EEC or one of the definitions in Article 1 paragraph 2 lit. a, c, d or e of Directive 90/385 / EEC,
p.(None): or
p.(None): 5. the list of products listed in Annex II to Directive 98/79 / EC is to be amended or expanded, or
p.(None): 6. the conformity of a product or a product group deviating from the provisions of Article 9 of Directive 98/79 / EC when applying a
p.(None): one or more alternative procedures selected from the procedures provided for in Article 9 of Directive 98/79 / EC.
p.(None): conformity assessment
p.(None): § 27. Medical devices may only be placed on the market or put into operation if they conform to the provisions of this
p.(None): Federal law was assessed in accordance with a regulation pursuant to Section 28.
p.(None): § 28. (1) The Federal Minister of Health and Consumer Protection has, taking into account the relevant legal acts of the European
p.(None): Communities to make more detailed regulations on the conformity assessment of medical devices by ordinance.
p.(None): (2) This Ordinance shall specify in particular:
p.(None): 1. Type, design and implementation of the conformity assessment procedures including the respective declarations of conformity and the
p.(None): Conditions for affixing the CE marking,
p.(None): 2. the assignment of the conformity assessment procedures to the individual classes of medical devices,
p.(None): 3. Which conformity assessment procedures are to be carried out by a notified body and which are to be carried out by the manufacturer,
p.(None): 4. those conformity assessment procedures which may be initiated by the authorized representative,
p.(None): 5. the storage and provision of documents in connection with conformity assessment procedures,
p.(None): 6. The more detailed requirements under which an exemption according to § 32 can be granted, as well as Art. Content, implementation and treatment
p.(None): the related requests,
p.(None): 7. Art. Content and requirements of the declarations to be issued for custom-made products as well as type and content of those for the responsible authorities
p.(None): available documentation,
p.(None): 8. Art. Content, availability and transmission of records of custom-made products that have been placed on the market or put into operation,
p.(None): 9. Which conformity assessment procedures may have to be carried out when medical devices are manufactured in health care facilities
p.(None): or put into operation.
p.(None): (3) The Federal Minister of Health and Consumer Protection can in a regulation in accordance with paragraph 1, as far as it is in the interest of a uniform and
...
p.(None): CE marking, for which the manufacturer has provided sterilization prior to use, must be sterilized for placing on the market for the first time, one of the
p.(None): Use the procedure described in Annexes II or V to Directive 93/42 / EEC. The application of these annexes and the involvement of the notified body are up
p.(None): limits the aspects of the sterilization process to achieve sterility of the medical device up to opening or damage to the packaging. The
p.(None): A person or company must provide a statement that the sterilization has been performed in accordance with the manufacturer's instructions.
p.(None): Section 35. (1) Medical devices within the meaning of Section 33 (1) and Section 34 may not be provided with an additional CE marking. You must
p.(None): Information according to § 9 and a regulation according to § 10 may be attached, which may also be that of the manufacturers of the composite
p.(None): Medical instructions included.
p.(None): (2) The declarations for the medical devices listed in para. 1 are for monitoring by the Federal Office for Safety in Health Care and
p.(None): to keep the experts commissioned by him available for five years.
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 which are to be carried out by notified bodies may only be carried out by such bodies
p.(None): Bodies are carried out by the European Commission and the other contracting parties to the Agreement on the European Economic Area for this purpose
p.(None): and in the Official Journal of the European Communities in the list of notified bodies, stating their identification number and the
p.(None): Tasks for which they were named are listed.
p.(None): (2) The Federal Minister of Health and Consumer Protection may appoint relevant domestic certification bodies with the appropriate expertise
p.(None): their application for the performance of certain tasks in connection with the procedures according to § 28 for certain medical devices or
p.(None): Name medical device groups if they are considered by the Federal Minister for Economic Affairs to carry out these tasks
p.(None): Certi fi cating body and as a testing or inspection body accredited in accordance with the Accreditation Act, Federal Law Gazette No. 468/1992, taking into account that
p.(None): the criteria of section 37 are met.
p.(None): (3) Bodies that meet the criteria set out in the relevant harmonized standards are assumed to meet the minimum criteria
p.(None): according to paragraph 2 are sufficient.
p.(None): (4) The Federal Minister of Health and Consumer Protection must revoke the appointment of a position if it finds that the position meets the criteria
p.(None): of paragraph 2 is no longer sufficient, or to restrict if it determines that it meets 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 to the Agreement on the European Economic Area and
p.(None): the European Commission immediately in terms of designations in accordance with paragraph 2 and on the revocation or restriction of a designation in accordance with paragraph 4
p.(None): To put knowledge.
p.(None): Minimum criteria for notified bodies
p.(None): Section 37. (1) The notified body, its manager and the personnel responsible for carrying out the assessments and tests must be independent of the body
p.(None): be the one who developed or designed the medical device to be assessed, as well as its manufacturer, distributor, installer or user You may not
p.(None): directly as a representative for the development or construction, for the manufacture, for distribution or for the applicant for the maintenance of these
p.(None): Products to be involved. This does not make it possible to exchange technical information between the manufacturer and the notified body
p.(None): locked out.
p.(None): (2) The notified body must be able to perform all the tasks provided for in a conformity assessment procedure in accordance with an ordinance pursuant to Section 28
p.(None): be assigned to such a body and for which it is designated, be it that these tasks are performed by the notified body itself or be that it is in
p.(None): Sub-areas are carried out under their responsibility. In particular, it must have the personnel and the resources necessary to meet the requirements of the
...
p.(None): must be taken into account, must be carried out according to a defined and methodically flawless procedure based on a critical assessment
p.(None): 1. the available relevant scientific literature on safety, performance, design features and purpose of the medical device,
p.(None): in which
p.(None): (a) the conformity of the medical device with the medical device to which the data relate must be demonstrated; and
p.(None): (b) the data are reasonably capable of demonstrating compliance with the relevant essential 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 class III medical devices of Directive 93/42 / EEC
p.(None): conduct clinical trials unless the use of existing clinical data is adequately proven.
p.(None): (4) The clinical evaluation and its result must be documented. This documentation or a detailed reference to it are in the technical
p.(None): Include documentation about the medical device.
p.(None): (5) The clinical evaluation and its documentation must be actively based on the data obtained from the post-marketing surveillance on the
p.(None): kept up to date. If post-marketing clinical monitoring is 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 does not consider it necessary to demonstrate compliance with the essential requirements
p.(None): Such an exception must be justified accordingly on the basis of clinical data within the meaning of paragraph 1. This justification has on the result
p.(None): of risk management and has the peculiarities of the interaction between body and medical device, the intended clinical performance and
p.(None): to take into account the information provided by the manufacturer. The suitability of demonstrating compliance with the essential requirements solely by
p.(None): Performance evaluation, product tests and preclinical evaluation must be justified separately.
p.(None): (7) Evidence that the performance-related requirements set out in Annex I, Chapter A, Section 3 of Directive 98/79 / EC have been
p.(None): Diagnostics are fulfilled under normal conditions of use, as well as the assessment of risks and the acceptability of the benefit / risk ratio on which
p.(None): Annex I, Chapter A, Section 1 of Directive 98/79 / EC, must always be based on performance data.
p.(None): (8) The evaluation of the performance data in accordance with paragraph 7, hereinafter referred to as "performance evaluation", where applicable the common
p.(None): technical speci fi cations and relevant harmonized standards must be taken into account in accordance with a de fi ned and methodologically perfect process
p.(None): to be done on the basis of a critical assessment
p.(None): 1. the available relevant scientific literature on safety, performance, design features and purpose of the in vitro
p.(None): Diagnostic agent, whereby
p.(None): (a) the conformity of the in vitro diagnostic medical device with the in vitro diagnostic medical device to which the performance data relate must be demonstrated; and
p.(None): (b) the performance data are reasonably capable of demonstrating compliance with the relevant essential requirements; or
p.(None): 2. the results of all performance assessment tests carried out, or
p.(None): 3. of published or unpublished reports about other clinical experiences with the relevant in vitro diagnostic or similar
p.(None): In vitro diagnostic medical device, the similarity of which 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 detailed reference to it are in the technical
p.(None): Include documentation of the in vitro diagnostic medical device. The performance appraisal and its documentation must be active on the basis of monitoring
p.(None): performance data received after placing on the market are kept up to date.
p.(None): Section 2
p.(None): Clinical trial
p.(None): Purpose of the clinical trial
...
p.(None): Sections 47 to 54 do not apply if the in vitro examinations carried out can have diagnostic or therapeutic consequences for the test participants
p.(None): for the performance evaluation of in vitro diagnostics.
p.(None): statutory authorization
p.(None): § 66. The Federal Minister of Labor, Health and Social Affairs has, if this is in view of the clinical evaluation, the proper planning,
p.(None): Implementation, evaluation and control of clinical trials or performance evaluation tests of in vitro diagnostics with a view to protecting the
p.(None): Health and safety of the trial participants and ensuring the scientific significance of clinical trials or
p.(None): Performance assessment tests appear to be required by regulation taking into account the relevant legal acts of the European Communities
p.(None): more detailed provisions regarding
p.(None): 1. The requirements for the clinical evaluation of medical devices, their documentation and their implementation, especially in the context of
p.(None): Conformity assessment,
p.(None): 2. those types, groups or classes of medical devices, the clinical evaluation of which in any case requires clinical data,
p.(None): 3. Further requirements for the planning, implementation and evaluation of clinical trials of medical devices or the
p.(None): Performance assessment testing 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 trial or the performance assessment exam
p.(None): involved people,
p.(None): 5. Art. Content, scope and design of the documents required for the conduct of the clinical trial or performance assessment exam,
p.(None): in particular the test plan, the evaluation plan, the manual of the clinical investigator, the final report, the documents for the clarification
p.(None): and obtaining consent, as well as statistical planning, analysis and evaluation and the 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 performance evaluation of in vitro diagnostic medical devices
p.(None): with regard to relevant harmonized standards
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) Anyone who is responsible for the initial placing on the market of medical devices in accordance with Section 2 (12), medical devices as defined in Section 33 (1)
p.(None): composed or sterilized within the meaning of § 34, and has its seat in the scope of this federal law, this has taken into account the
p.(None): Provisions of an ordinance according to paragraph 7 to the Federal Ministry of Labor, Health and Social Affairs or a body designated by the Federal Ministry of Labor before admission
p.(None): to report the activity. This also applies to the further placing on the market of medical devices, insofar as this is covered by an ordinance pursuant to Section 99 sales 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 that is necessary for the rapid coordination of measures in accordance with sections 75 and 77, in particular with regard to the
p.(None): Security officers according to § 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, for more information on the medical devices
p.(None): that are placed on the market for the first time.
p.(None): (3) Bodies, facilities or persons who carry out testing, monitoring or certi fi cation activities in accordance with this Federal Act on a professional or commercial basis
p.(None): have to do this before starting work at the Federal Ministry of Labor, Health and Social Affairs or a body designated by the latter
p.(None): Indication of the name and address of the body, facility or person and the type of testing, monitoring and certi fi cating activities carried out
p.(None): Report. Notified bodies within the meaning of Section 2 (16) have the Federal Ministry of Labor, Health and Social Affairs or a body designated by it
p.(None): Information related to certificates issued in accordance with the procedures in Annexes 2 to 5 of Directive 90/385 / EEC, Annexes II to VII of the Directive
p.(None): 93/42 / EEC and Annexes III to VII to Directive 98/79 / EC were issued, modified, supplemented, suspended, withdrawn or refused to notify. The
p.(None): Federal Minister of Labor, Health and Social Affairs has the type, form and content of the relevant reports in accordance with the requirements in connection
p.(None): to be regulated with the European databases for medical devices in a regulation in accordance with paragraph 7.
p.(None): (4) Healthcare facilities that operate or use medical devices or have them ready for operation or use, which are in a
p.(None): Ordinance pursuant to Paragraph 7 are listed under the Federal Ministry of Health and Consumer Protection or a body designated by the latter
p.(None): Specification of the type of medical devices, the name and address of the facility and data on accessibility via telecommunications facilities
p.(None): Report. When designating the medical devices in the regulation according to paragraph 7, there is a significant risk potential for these medical devices and that
p.(None): Need to be promptly informed of these facilities in the cases of Section 77 and 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 parties to the Agreement about the European
p.(None): Economic area and the European Commission on their request and by means of a common European data network on the
p.(None): Reports according to paragraphs 1, 2 and 5.
p.(None): (7) The Federal Minister of Health can take into account the uniformity of the reports and the one for medical device monitoring
p.(None): stipulate the required information by ordinance Art. Content, 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 the directive 93/42 / EEC and for in-vitro diagnostics of Annex II and in-vitro diagnostics
p.(None): The Federal Minister of Health may notify the Federal Minister of Health of all information that identifies the medical device in order to apply Directive 98/79 / EC
p.(None): enable and determine the labeling and instructions for use if these medical devices are in operation within the scope of this federal law
...
p.(None): 2. previously unknown serious side effects or the increased occurrence of known serious side effects, or
p.(None): 3. previously unknown mutual influences, or
p.(None): 4. serious quality defects,
p.(None): who have become aware of them as a result of their professional activities must be reported immediately to the Federal Office for Safety in Health Care and all
p.(None): Communicate observations and data that may be important for medical device safety.
p.(None): (2) Reports in accordance with paragraph 1 have to be made uniformly by the medical director at hospitals, unless there is any other imminent danger.
p.(None): (3) All natural or legal persons who place medical devices on the EEA for the first time and those companies, facilities or persons who
p.(None): Placing medical devices on the market has the Federal Office for Safety in Healthcare immediately incidents according to paragraph 1 and beyond
p.(None): corrective measures, such as
p.(None): 1. Any technical or medical reason associated with a medical device that leads to the systematic recall of medical devices of the same
p.(None): Type of the market led by the manufacturer,
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 to ensure that the first-time placing on the market in the EEA
p.(None): Responsible person is also informed of an incident in accordance with paragraph 1.
p.(None): (5) Insofar as it is necessary to ensure the uniformity and the information content of the reports, the Federal Minister of Health and
p.(None): Consumer protection taking into account the requirements of in-depth and rapid information by ordinance, more detailed provisions on content, scope,
p.(None): To issue the form and transmission of the messages as well as the data carriers and communication channels to be used.
p.(None): (6) All natural or legal persons who place medical devices on the EEA for the first time and those companies, facilities or persons who
p.(None): Placing medical devices on the market is obliged to report and inform you in connection with incidents in accordance with paragraphs 1 and
p.(None): Measures under paragraph 3 towards the contracting parties of the EEA in accordance with Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC immediately and
p.(None): verifiably to comply.
p.(None): (7) After the Federal Office for Safety in Health Care an incident according to paragraph 1 and measures according to paragraph 3, if possible
p.(None): jointly with the manufacturer or his authorized representative, the European Commission and the other Member States must immediately report it
p.(None): to inform the measures taken. This includes information about the underlying incidents.
p.(None): Registration and evaluation of reports; investigations
p.(None): Section 71. The Federal Office for Safety in Health Care must record, evaluate and inform the information brought to its attention in accordance with section 70
p.(None): if necessary, to determine, coordinate and monitor the measures to be taken under this Act. The responsibilities and duties
p.(None): the persons responsible for the placing on the market as well as the professional or professional users and operators in accordance with § 72 are not affected.
p.(None): Section 72. (1) The users and operators of medical devices in health care facilities and those for the placing on the market of
p.(None): Medical devices are responsible, especially in connection with the evaluation of reports according to § 70 or a reasonable suspicion
p.(None): According to § 75, which you have become aware of in the course of your professional or commercial activity,
p.(None): 1. Take all necessary measures and precautions in your own area to avoid possible risks and dangers to health and safety
p.(None): Recognize and evaluate patients, users or third parties,
p.(None): 2. All necessary precautions and measures, in particular also with regard to the disclosure of information about dangers from medical devices
p.(None): meet to ensure the protection of the health and safety of patients, users or third parties, and
p.(None): 3. To support investigations by the responsible authorities with all available means and, if necessary, to conduct own investigations
p.(None): To carry out or arrange for medical devices and to make their results immediately available to the responsible 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, as far as this is important for the evaluation, also combinations
p.(None): with accessories, with other medical devices, with drugs or other products to make them accessible for examinations,
p.(None): 2. If applicable, documents and other information, as well as certi fi cates and other information about the conformity assessment procedures carried out
p.(None): To make accessible, which enable an assessment of the extent to which the medical device and its manufacture meet the requirements of this federal law
p.(None): correspond,
p.(None): 3. if necessary, enable comparisons with similar or similar medical devices from our own area,
p.(None): 4. to provide information on the exact identification of the affected medical devices or combinations in accordance with Z 1,
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 installation, erection, maintenance and application of the
p.(None): to provide affected medical devices with the necessary information and advice.
p.(None): Section 72a. (1) If there is reasonable suspicion that a patient has suffered health damage or was killed as a result of a defective medical device,
...
p.(None): Users or third parties and the defense against risks is required, considering types, groups or classes of medical devices with increased
p.(None): Risk potential through ordinance for the placing on the market of medical devices and those responsible for health care facilities
p.(None): To take precautions and measures with regard to the traceability of medical devices and to make stipulations about
p.(None): 1. the types, groups or classes of medical devices that are covered by the traceability requirements,
p.(None): 2. the product or product group-speci fi c requirements with regard to traceability as well as with regard to type, content, speci fi city and availability of
p.(None): records required in this regard, and
p.(None): 3. the manner in which suitable implant registers are set up in healthcare facilities and the necessary records.
p.(None): observational
p.(None): § 74. The Federal Minister of Health and Consumer Protection can consider serious interests of public health and
p.(None): with a view to gaining improved knowledge about the benefit / risk assessment of certain types or groups of medical devices, in particular
p.(None): also about the long-term effects of implantable medical devices that can only be obtained through systematic data collection and analysis
p.(None): can, by regulation, prescribe that relevant data, which have been collected in connection with the use of these medical devices and for which
p.(None): Obtaining these findings are necessary for a central evaluation. As part of the central collection and evaluation
p.(None): Such personal data must be removed 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 the health or safety of patients, users or third parties even with proper implantation, erection, maintenance
p.(None): or endanger its intended use to an extent that is acceptable according to the knowledge of medical science
p.(None): can, or
p.(None): 2. a medical device fulfills the basic requirements within the meaning of §§ 8, 9, a regulation according to § 10 or, if applicable, the requirements of § 11
p.(None): not met, or
p.(None): 3. a medical device has other defects that can lead to an unacceptable risk to patients, users or third parties, or
p.(None): 4. Defects have occurred or occur in the course of the development, manufacture or final inspection of a medical device, which lead to an unacceptable one
p.(None): Can endanger patients, users or third parties,
p.(None): the Federal Office for Safety in Health Care has to carry out the necessary assessments, monitor measures in accordance with Section 72, necessary
p.(None): Carry out or arrange for examinations or the person or device that places the medical device on the market, uses, puts into operation or
p.(None): operates to arrange for the medical device to be checked by a notified body, another suitable accredited body or by an expert
p.(None): leave and present the reports and results to him. The positions or experts are in agreement with the Federal Office for Security in the
p.(None): Select healthcare.
p.(None): Section 76. (1) As part of the assessment of reports in accordance with Section 70 (1), the assessment must extend in particular 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, in particular with regard to similar medical devices,
p.(None): make necessary.
p.(None): (2) Cash expenses incurred by the Federal Office for Safety in Health Care in connection with an assessment in accordance with Section 75 and Paragraph 1
p.(None): to be borne by the person responsible for placing the product on the market if, on the basis of such an assessment, a measure within the meaning of Section 77 results from a defect
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): health
p.(None): General requirements
p.(None): Section 80. (1) Healthcare facilities must ensure that
p.(None): 1.Medical devices only in accordance with their intended purpose, in accordance with the provisions of this Federal Act or those adopted on the basis thereof
p.(None): Regulations, the generally recognized rules of technology as well as the occupational safety and accident prevention regulations are established, operated and applied
p.(None): and be maintained
p.(None): 2. Medical devices for joint use with other medical devices, with accessories, with software or with other objects only then
p.(None): be connected if this connection is harmless with regard to medical safety and functionality,
p.(None): 3. Medical devices are only used by people who, based on their training, their other knowledge or on the basis of their
p.(None): practical experience and, if necessary, product- or product-group-specific instruction guarantee the correct handling
p.(None): Offer; the instructions for use and the other enclosed safety-related information of the products involved must be observed,
p.(None): 4. Before each use of a medical device, the user should check the functionality, operational safety and the proper condition of the
p.(None): Medical device convince insofar as such a review can be reasonably expected according to the circumstances of the specific application; this applies
p.(None): correspondingly also for the other medical devices, accessories, software and others associated with the medical device for common use
p.(None): objects
p.(None): 5. only medical devices are installed, kept ready, put into operation and used in their area, their compliance with the
p.(None): Requirements according to the procedures provided for this by this federal law.
p.(None): (2) The Federal Minister of Health and Consumer Protection has prescribed certain types, groups or classes of medical devices
p.(None): the requirements in accordance with Paragraph 1 with regard to the erection, operation, use and maintenance of medical devices in
p.(None): Establish health care facilities insofar as this is necessary to avert special dangers for patients, users or third parties and so far
p.(None): special requirements for this have not already been laid down on the basis of commercial law.
p.(None): Commissioning, application
p.(None): Section 81. (1) The Federal Minister of Health and Consumer Protection, insofar as this is with regard to the safe use of medical devices in
p.(None): Health care facilities or the defense against application or other medical device-related dangers is required by regulation types,
p.(None): To designate classes or groups of medical devices, to take special safety precautions for their safe operation and safe use
p.(None): and specify the minimum requirements for the type and scope of these security measures. To the extent provided by such a regulation
p.(None): The Federal Minister of Health and Consumer Protection has provided information on the use of medical devices by traders
p.(None): Agreement with the Federal Ministry of Economic Affairs.
p.(None): (2) The institution or person responsible for the implantation of a medical device has the patient to whom a medical device is implanted, or
p.(None): if necessary, to provide his legal representative with information in which all for the identification of the implanted medical device including the
p.(None): Information required as well as information and instructions for the safety of the patient after the implantation
p.(None): are included, including information about when the patient should see a doctor and what environmental influences he or she is not observing or only taking into account
p.(None): appropriate precautions. The relevant information in the instructions for use and the other attached
p.(None): The safety-related information of the implantable medical devices must be observed.
p.(None): (3) The Federal Minister of Health and Consumer Protection, if this takes into account the protection of health and safety and the
p.(None): Rights of patients and with regard to uniformity and practicability appears necessary in a regulation according to § 92 more detailed provisions
p.(None): Art. Content, scope, issuance and accessibility of information according to paragraph 2 as well as other personal data intended for patients in the
p.(None): Related to the use of medical devices.
p.(None): (4) When informing patients in connection with the use of medical devices, refer to the corresponding information in the
p.(None): Use instructions carefully.
p.(None): Information for users
p.(None): § 82. Instructions for use and safety-related information for the user attached to the medical device are in the sense of medical devices
p.(None): of section 81 (1) must be kept in such a way that they are accessible at all times to the persons involved in its use.
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 who work on the medical device or on a device
p.(None): Medical device of this type taking into account the instructions for use and the attached safety-related information in the appropriate
p.(None): Have been instructed in handling and have also been advised of special application and medical device-specific dangers. Only those are allowed
p.(None): Instruct people who, on the basis of their training, knowledge and practical experience, are instructed in the handling of these medical devices
p.(None): are suitable. If necessary, the operator must provide recurring training.
p.(None): (2) If medical devices are combined with accessories, software or other medical devices in accordance with a regulation pursuant to Section 81 (1)
p.(None): extended, the instruction of the personnel has to extend to the respective combinations and their special features.
...
p.(None): (2) The device directory in accordance with paragraph 1 can be kept in one with the inventory in accordance with § 84.
p.(None): (3) Recurring tests, tests after repair or after incidents and their results are to be documented and in the
p.(None): List of devices. The intervals of recurring tests and briefings according to § 83 must also be kept evident in the device directory.
p.(None): Suitability for exams
p.(None): Section 90. (1) Only persons who:
p.(None): 1. on the basis of their professional training and their experience gained through practical work in the testing of medical devices as well as their
p.(None): Knowledge, especially with regard to 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 necessary organizational requirements for planning, implementation and
p.(None): Evaluation of the exams
p.(None): and are able to carry out the examinations in accordance with §§ 86 to 88 properly and comprehensibly in terms of type and scope. Other than that in
p.(None): Paragraph 2 mentioned testing, monitoring or certification bodies are suitable for the tests if they have persons in the sense of Z 1 to 4.
p.(None): (2) Relevant bodies accredited as testing or monitoring bodies for products for the relevant medical device sector are in any case considered as in the sense
p.(None): appropriate paragraph.
p.(None): Avoiding hazards
p.(None): § 91. As far as hazards for patients, users or third parties can arise in the course of measures for the maintenance of a medical device
p.(None): take appropriate measures to avert these hazards from people.
p.(None): statutory authorization
p.(None): § 92. (1) The Federal Minister of Health and Consumer Protection has to guarantee and maintain the medical performance of
p.(None): Medical devices according to § 2 paragraph 1 or 5 and to ensure the continuity of their safe use and the defense against risks, especially under
p.(None): Consideration of the nature of the establishment of health care by ordinance specifies the establishment, operation, application and
p.(None): Maintenance of medical devices or certain types or groups of medical devices, insofar as the electrotechnical safety and the dimension and
p.(None): The functions of medical devices covered by the calibration law are to be determined in agreement with the Federal Minister for Economic Affairs. He
p.(None): has to take into account relevant harmonized standards. If there are no such in the speci fi c regulation area, he can apply to others
p.(None): refer to appropriate 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 in accordance with 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 are authorized to carry out maintenance measures or carry out tests 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 are subject to regular reviews,
p.(None): 7. Types, groups or classes of medical devices which are subject to a maintenance obligation in accordance with Section 85 (4) 1 or 2, including
p.(None): any requirements for the availability and use of these medical devices and the necessary training measures as well
p.(None): 8. Type, scope, implementation and intervals of examinations in accordance with sections 86 to 88
p.(None): to be issued and to designate those medical devices for which special safety precautions must be taken for their safe operation or safe use
p.(None): are, as well as minimum requirements for their type and scope.
p.(None): (3) The umbrella organization of social insurance institutions is before issuing an ordinance in accordance with paragraph 1 regarding medical devices within the meaning of § 85 paragraph 4
p.(None): Z 1 can be heard.
p.(None): Section 2
p.(None): Cleaning, disinfection and sterilization of medical devices in or for healthcare facilities
p.(None): Section 93. (1) Cleaning, disinfection and sterilization of medical devices in or for healthcare facilities are without prejudice to Section 34 below
p.(None): Consideration of the type of medical devices with such devices or device systems and suitable validated procedures and how to perform
p.(None): to organize the type, size and task of the facility in such a way that the success of these procedures is comprehensibly guaranteed and safety
p.(None): and the health of patients, users or third parties is not endangered.
p.(None): (2) Cleaning, disinfection and sterilization of medical devices in or for health care facilities have, in particular, that in one
p.(None): Regulation in accordance with § 94 requirements.
p.(None): § 94. The Federal Minister of Health and Consumer Protection has taken into account the type and size of the institution of health care and
p.(None): taking into account the relevant harmonized standards, other relevant international or national standards with regard to the guarantee
p.(None): the protection of the safety and health of patients, users or third parties by ordinance to enact 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 for the construction, commissioning, application, maintenance, disinfection and sterilization of
p.(None): Medical devices in healthcare facilities
p.(None): Section 95. (1) The Federal Minister of Health and Consumer Protection, insofar as this applies to the construction, commissioning, use, maintenance,
p.(None): Disinfection and sterilization of medical devices 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 or 5, the minimization of possible side effects that
p.(None): Compliance with basic requirements, ensuring the safety and health of patients, users or third parties or the defense against
p.(None): Risks are required and are indicated in terms of the type and scope of the facility, by regulation minimum requirements for measures and
p.(None): Establish quality management arrangements. 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 of Health and Consumer Protection can by ordinance
p.(None): Define requirements and requirements under which systems of quality management in health care facilities with regard to
p.(None): Erection, application, operation, maintenance, disinfection and sterilization of medical devices or certain types or groups of
p.(None): Medical devices can be certi fi ed within the meaning of this federal law. He has any relevant national and international standards
p.(None): consider.
p.(None): (3) The Federal Minister of Health and Consumer Protection can with regard to the proper testing, monitoring and certi fi cation of
p.(None): Quality management systems with regard to the construction, application, operation, maintenance, disinfection and sterilization of medical devices
p.(None): or certain types or groups of medical devices in healthcare facilities and to ensure compliance with the requirements
p.(None): in accordance with a regulation in accordance with paragraph 2, stipulate requirements and requirements for those bodies that have quality management systems in accordance with paragraphs 1 and 2
p.(None): check, monitor or certify. He has to take into account any relevant national and international standards.
p.(None): § 96. The Federal Minister of Health and Consumer Protection has, if this is with regard to serious interests of public health or
p.(None): the prevention of serious risks is required by regulation the use or operation of certain types or groups of medical devices
p.(None): Restrict healthcare institutions, whose quality management systems in this regard demonstrably meet the requirements of a regulation
p.(None): in accordance with section 95 (1) or certified in the sense of a regulation in accordance with section 95 (2).
p.(None): minimum standards
...
p.(None): §§ 5a and 5b including headings, § 8 paragraphs 4 and 5, the introductory words of § 15 paragraph 2, § 22 paragraphs 2 and 3, § 23, §§ 26a and 26b including heading, § 28 paragraph 2 line 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 Section 1 of III. Main piece, § 38, § 40, §§ 40a
p.(None): and 40b including headings, § 41 paragraph 1, 2, 4 and 6, § 42 paragraph 8, § 43, § 44, § 47 paragraph 1, 2 and 3, § 49, § 50 paragraph 1, 2 and 4, § 51, § 52a para. 3, § 56 para. 3 to 7,
p.(None): Section 59 subsection 1, 1a and 3, Section 60 subsection 1 to 3, Section 61, Section 63 subsection 4 to 6, Section 64 subsection 1, 4 and 7, Section 65, Section 65a subsection 1 and 2, Section 66, Section 67 subsection 7, Section 70 subsection 1, 3, 4, 6 and 7, Section 77
p.(None): Para. 1 Z 2a and 3, § 77 Paragraph 2a, § 111 Z 5, 13 and 15, § 113, § 116 Paragraph 2 and 3, § 116a Z 7, as amended by Federal Law BGBl. I № 143 / 2009 join
p.(None): March 21, 2010 in force. Section 68 (11) to (13) as amended by Federal Law Gazette I No. 143/2009 comes into force on January 1, 2010.
p.(None): (10) Data protection consent in connection with clinical trials that were issued before May 25, 2018, need not be renewed
p.(None): become.
p.(None): (11) Section 11 (4), Section 49 (4), 5 and 6, Section 50 (1), Section 52a (3) and (5), Section 55 (1), Section 59 (3) and Section 64 (3) 4a, § 73 paragraphs 1, 2, 4, 4a, 5, 6, 8, 11, 12 14, 17,
p.(None): § 73a paragraphs 2, 3, 5, 6, 9, 11 and 12, § 74, § 89 paragraphs 1 to 3, § 110a paragraphs 1 to 3 and the cancellation of § 73 paragraphs 9, 10 and 18 and of 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 (2) and (4) and Section 52 of this Federal Act, version BGBl. I No. 59/2018, come into force on July 1, 2018.
p.(None): Section 115. Ordinances based on this federal law can be enacted from the day following its announcement. they may
p.(None): earliest with the entry into force of this federal law.
p.(None): Section 116. (1) With the entry into force of this Federal Act, the Health Protection Act, Federal Law Gazette No. 163/1952, shall cease to apply.
p.(None): (2) The ordinance concerning dental amalgam, Federal Law Gazette № 575/1990, comes into effect on the day of the publication of this Federal Act in the version of the
p.(None): Federal Law BGBl. I No. 143/2009 no longer applicable.
p.(None): (3) The condom examination ordinance, Federal Law Gazette № 630/1990, comes into force at the end of the day of publication of this federal law in the version of the
p.(None): Federal Law BGBl. I No. 143/2009 no longer applicable.
p.(None): Reference to guidelines
p.(None): § 116a. This federal law implements the following guidelines of the European Community:
p.(None): 1. Directive 90/385 / EEC on active implantable medical devices (OJ No L 189, 20 July 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 exercise of patient rights in cross-border
p.(None): Health care (OJ No L 88, 4 April 2011, p. 45);
p.(None): 9. Commission Implementing Directive 2012/52 / EU of 20 December 2012 with measures to facilitate the recognition of one in another
p.(None): Medical prescriptions issued by the Member State (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 of Labor, Health and Social Affairs in agreement with
p.(None): the Federal Minister for Economic Affairs,
p.(None): 3. With regard to Section 80 (2), Section 81 (1) and Section 92, insofar as electrotechnical safety, the measuring functions of
p.(None): Medical devices and commercial law provisions are concerned, and with regard to Section 99 (1), as far as commercial law concerns are concerned,
p.(None): the Federal Minister for Health and Consumer Protection in agreement with the Federal Minister for Economic Affairs and
p.(None): 4. With regard to Section 98 (1), the Federal Minister for Health and Consumer Protection in agreement with the Federal Minister for Economic Affairs
p.(None): Affairs
p.(None): entrusted.
p.(None): (2) Before enacting ordinances in accordance with this federal law, the federal ministers responsible in accordance with para
p.(None): Experts in the field of matter to be regulated in each 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 Austrian Dental Association, the Federal Chamber of Labor,
p.(None): the Austrian Chamber of Commerce, the Austrian Chamber of Pharmacists, the Main Association of Austrian Social Insurance Institutions, the
p.(None): Belong to Austrian Agency for Health and Nutritional Security GmbH, business unit PharmMed, and the Austrian Senior Council.
p.(None): Furthermore, according to the state law implementing provisions to § 11e of the Federal Law on Hospitals and Health Centers (KAKuG)
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| army | Soldier |
| authority | Relationship to Authority |
| breastfeeding | breastfeeding |
| child | Child |
| children | Child |
| dependent | Dependent |
| disability | Mentally Disabled |
| 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 |
| threat | Threat of Stigma |
| union | Trade Union Membership |
| usage | Drug Usage |
| women | Women |
| youth | Youth/Minors |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| 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