Federal law consolidated: Entire legal provision for the Medical Devices Act,
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Federal Act on Medical Devices (Medical Devices Act - MPG)
StF: BGBl. No. 657/1996 (NR: GP XX RV 313 AB 389 p. 43. BR: AB 5286 p. 618.)
[CELEX No .: 390L0385, 393L0068, 393L0042]
modification
BGBl. I No. 30/1998 (NR: GP XX RV 915 AB 1037 p. 104. BR: AB 5611 p. 634.)
BGBl. I No. 117/1999 (NR: GP XX RV 1778 AB 1983 p. 174. BR: AB 5984 p. 656.)
[CELEX No .: 398L0079]
BGBl. I No. 98/2001 (NR: GP XXI RV 621 AB 704 p. 75. BR: 6398 AB 6424 p. 679.)
BGBl. I No. 33/2002 (NR: GP XXI RV 777 AB 934 p. 89. BR: 6541 AB 6566 p. 683.)
[CELEX No .: 398L0027]
BGBl. I No. 119/2003 (NR: GP XXII RV 236 AB 289 p. 37. BR: 6888 AB 6904 p. 703.)
[CELEX-No .: 32000L0070, 32001L0104]
BGBl. I No. 107/2005 (NR: GP XXII RV 675 AB 720 p. 90. BR: AB 7180 p. 717.)
BGBl. I No. 153/2005 (NR: GP XXII RV 1092 AB 1142 p. 125.)
[CELEX-No .: 32004L0024, 32004L0027, 32004L0028]
BGBl. I No. 77/2008 (NR: GP XXIII RV 504 AB 531 p. 59. BR: AB 7943 p. 756.)
BGBl. I No. 143/2009 (NR: GP XXIV RV 466 AB 549 p. 49. BR: AB 8236 p. 780.)
[CELEX-No .: 32007L0047, 32009L0120]
BGBl. I No. 32/2014 (NR: GP XXV RV 33 AB 77 S. 17. BR: AB 9151 S. 828.)
[CELEX-No: 31989L0105, 32009L0050, 32011L0024, 32011L0051, 32011L0095, 32011L0098, 32012L0052,
32013L0025]
BGBl. I No. 37/2018 (NR: GP XXVI RV 108 AB 139 P. 23. BR: 9967 AB 9970 P. 880.)
[CELEX-No .: 32017L2399, 32017L1572]
BGBl. I No. 59/2018 (NR: GP XXVI RV 191 AB 231 S. 36. BR: 10001 AB 10017 S. 883.)
BGBl. I No. 100/2018 (NR: GP XXVI RV 329 AB 413 p. 57. BR: 10079 AB 10082 p. 888.)
text
Article II
(Note: amendment of the Measurement and Verification Act, Federal Law Gazette No. 152/1950)
Article III
(Note: Amendment to the Radiation Protection Act, Federal Law Gazette No. 227/1969)
Article IV
(Note: Amendment of the Medicinal Products Act, Federal Law Gazette No. 185/1983)
I. MAIN PIECE
Section 1
scope of application
§ 1. This federal law regulates the functionality, performance, safety and quality
Manufacturing, placing on the market, distribution, construction, commissioning, maintenance, the
Operation, application, clinical evaluation and testing, monitoring and sterilization,
Disinfection and cleaning of medical devices and their accessories as well as defense against risks and that
Quality management when handling medical devices and their accessories.
Section 2
definitions
General definitions
§ 2. (1) Medical Devices “are all instruments used individually or in combination,
Apparatus, devices, software, materials or other objects, including those from the manufacturer
Specifically designed for use in diagnostic or therapeutic purposes and for a flawless
Function of the medical device software used by the manufacturer for application to people
are intended for the following purposes:
1. detection, prevention, monitoring, treatment or relief of diseases,
2. Detect, monitor, treat, alleviate or compensate for injury or
disabilities,
3. Examination, change or to replace the anatomical structure or physiological
Operations or
4. Conception regulation
and their intended main effect in or on the human body neither through
pharmacological or immunological agents are still metabolically achieved, but their mode of action
can be supported by such means. The new one is a reprocessed medical device
equal.
(1a) “Subcategory of medical devices” is a group of medical devices that are used in the same
Areas to be used or equipped with the same technologies.
(1b) "Generic product group" is a group of medical devices with the same or similar
Terms of use or with technological similarities so that they are general without
Taking into account specific characteristics that can be classified.
(1c) "Disposable product" is a medical device that is for single use on a single person
is determined.
(2) "Accessories" for a medical device are objects, materials, preparations from materials and
Software that is not itself a medical device according to paragraph 1, according to the manufacturer's express
specified purpose but are intended
1. To be used together with a medical device, so that it complies with the requirements of
Manufacturer of the medical device specified purpose of the medical device applied
can be, or
2. to support the intended purpose for the medical device.
Accessories are considered medical devices. Accessories for active implantable medical devices are themselves considered active
implantable medical device. Accessories for an in-vitro diagnostic device are themselves considered in-vitro diagnostic devices,
unless the products are invasive and are intended for taking samples,
that come into direct contact with the human body for the purpose of sampling. This
are considered medical devices within the meaning of Directive 93/42 / EEC.
(3) "Active medical device" is any medical device that is operated by an electrical device
Energy source or another energy source is dependent on that directly by the human
Body or gravity generated energy. A medical device that is used to transfer energy,
Bumps or parameters between an active medical device and the patient is used without
the fact that there is a significant change in energy, impact or parameters does not count as active
Medical product.
(4) "Active implantable medical device" is any medical device that operates on an electrical device
Energy source or any energy source other than that directly through the human body or the
Gravity-generated energy, and is designed to be wholly or partially by one
surgical or other medical intervention in the human body or through a
medical intervention to be introduced into a natural opening of the body and is intended after the
Intervention to stay there.
(5) "Medical device for in-vitro diagnosis" or "in-vitro diagnostic device" is any medical device that
1. individually or in combination as specified by the manufacturer
a) reagent,
b) reagent product,
c) calibration material,
d) control material,
e) kit,
f) instrument,
g) apparatus, device or
h) system
for the in vitro analysis of samples from the human body, including
Blood and tissue donation is used, and
2. serves solely or predominantly to
a) Information about physiological or pathological conditions or congenital anomalies
give or
(b) check the safety and tolerability of the potential recipients, or
c) monitor a therapeutic measure.
Sample containers, evacuated or non-evacuated, by the manufacturer are also considered to be in vitro diagnostics
especially for the in vitro analysis of samples from the human body as
Primary container are intended for storage. Products for general laboratory needs do not apply
as in vitro diagnostics, unless they are based on their characteristics according to the manufacturer
to use the intended purpose for in vitro investigations within the meaning of Z 2.
(5a) "In-vitro diagnostic for self-use" is any in-vitro diagnostic that is based on the
Manufacturer specified purpose of laypersons can be applied in the home environment.
(5b) “Calibration and control material” are substances, materials and objects that are manufactured by your
Manufacturer to compare measurement data or to test the performance characteristics of an in vitro
Diagnostic agents are intended for the application for which it is intended.
(5c) "Medical device with a derivative from human blood" is a medical device according to the
Directive 90/385 / EEC or Directive 93/42 / EEC, which contains a substance as a component, which - separately
used - as a drug component or drug from human blood or blood plasma in the sense
of Art. 1 Point 10 of Directive 2001/83 / EC and in addition to the medical device
can have an effect on the human body. The aforementioned shock is referred to below as “derivative
from human blood ”.
(6) "Custom-made products" are all medical devices, with the exception of in vitro diagnostic medical devices, which according to
written prescription from a doctor or another legally based on their professional qualifications
authorized person, under their responsibility, specially made according to speci fi c design criteria
and are intended for exclusive use in a named patient.
Standard medical devices that have to be adapted to the speci fi c
To meet the requirements of the doctor or any other licensed user authorized to do so,
are not considered to be custom-made.
(7) "Manufacturer" is any natural or legal person responsible for the design, manufacture, packaging
and labeling a medical device with a view to placing it on the market for the first time
Name is responsible. This applies regardless of whether these activities are carried out by this person or
Company or acting on behalf of a third party.
(8) A manufacturer is also any natural or legal person who has one or more prefabricated ones
Assembled, packaged, treated, prepared or labeled products or for determining the products
Intended use as a medical device with regard to the placing on the market in your own name
is. However, a manufacturer is not someone who has already been placed on the market without being a manufacturer within the meaning of paragraph 7
Assembled products for a named patient according to their intended use
adapts.
(8a) "Authorized Representative" is the natural or established in the European Economic Area (EEA)
legal person who has been expressly designated by the manufacturer with regard to his from this
Federal law obligations to act on his behalf and those of the authorities and
To be contacted in this sense in the EEA. Has a manufacturer in its own name
Medical device, does not have a seat in a contracting party to the EEA, it must be in writing for
at least all medical devices of the same model have a single authorized representative in
Name EEA.
(9) "Intended use" is the use for which the medical device is designed according to the information provided by the
Manufacturer in the label, the instructions for use or the advertising material.
(10) "Placing on the market" is the return of a medical device, whether for a fee or free of charge, or that
Have it ready for delivery. A placing on the market does not exist if
1. it is a medical device exclusively intended for clinical testing within the meaning of § 3
Paragraph 3 or an in vitro diagnostic medical device for performance evaluation purposes within the meaning of Section 3 Paragraph 3a
These,
2. it is ensured by means of suitable measures that the medical device does not reach the consumer,
Can reach users or operators, or
3. individual medical devices to a single specific person exclusively free of charge and in
private area or neighborhood help.
(11) "Placing on the market for the first time" is the first placing on the market of a medical device or the first
Placing a medical device on the market after its reprocessing with a view to its distribution or
its use within the scope of the Agreement on the European Economic Area.
(12) "Responsible for the first placing on the market in the European Economic Area"
1. the manufacturer,
2. his representative or
3. the importer,
which is a medical device for the first time within the scope of the Agreement on the European
Puts the economic area on the market and within the scope of the Agreement on the European
Economic area is established.
(13) “Commissioning” is the phase in which a medical device is used by the end user as an article
Is made available for the first time as a ready-to-use medical device according to its
Purpose in the scope of the European Economic Area can be used. at
active implantable medical devices is considered to be the commissioning provided by the
medical personnel for implantation.
(14) "Exhibiting" is the setting up or demonstration of medical devices for the purpose of advertising or
the information of the specialist circles.
(15) "Harmonized standards" are national standards of the contracting states to the Agreement on the
European Economic Area implementing relevant harmonized European standards, their
Locations as "harmonized standards" for medical devices in the Official Journal of the European Communities
have been published. The harmonized standards are relevant monographs of the European
Pharmacopoeia for medical devices, their sources in the Official Journal of the European
Communities have been released. The harmonized standards are also common
Technical speci fi cations that are in accordance with Article 7 (2) of Directive 98/79 / EC of the European Parliament
and the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331 of 7 December 1998)
adopted and published in the Official Journal of the European Communities. In these
Speci fi cations are used in a suitable manner to define the criteria for the evaluation and re-evaluation of the
Performance, the batch release criteria, the reference methods and the reference materials.
(16) "Notified Body" is one of a Contracting Party to the Agreement on the European
Economic area of ​​the European Commission and the other contracting parties for the
Execution of tasks in the context of conformity assessment procedures for medical devices
notified body.
(17) “Side effects” are those when the medical device is used as intended
occurring and related undesirable side effects.
(18) "Mutual influence" means those that occur when used as intended
Effects of
1. Medical devices on top of each other or
2. Medical devices and other objects, substances or preparations made of substances on top of each other.
(19) "Maintenance" of a medical device is the entirety of the measures for preservation and
Restoration of the desired target state and for the determination and assessment of the
Current state of a medical device. The term "maintenance" includes inspection, maintenance and
Repair.
(20) "Inspection" of a medical device is the entirety of all measures to determine and
Assessment of the current status.
(21) "Maintenance" of a medical device is the entirety of all measures for the preservation of the
desired target state, the flawless safety and functionality of the medical device
guaranteed.
(22) "Repair" of a medical device are the measures to restore the
specified target state, the flawless safety and functionality of the medical device
guaranteed.
(23) 'Healthcare institution' means any institution, post or institution in which
Medical devices used by healthcare professionals or authorized professionals
operated or applied, including those of the Federal Army that the
Serve medical supplies.
Definitions for clinical evaluation and testing of medical devices as well as for
Performance assessment testing of in vitro diagnostic medical devices
§ 3. (1) "Clinical evaluation" is the medical evaluation of a medical device in the sense of
Annex 7 № 1.1 of Council Directive 90/385 / EEC of June 20, 1990 on the approximation of the
Member States legislation on active implantable medical devices, OJ. EG № L 189
of July 20, 1990, and Annex X № 1.1 of Council Directive 93/42 / EEC of June 14, 1993 on
Medical devices, OJ EG No.L 169 of July 12, 1993.
(2) "Clinical Trial" is a systematic examination of a medical device, with the exception of in-
in vitro diagnostics, on test subjects, with the aim of
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 by the manufacturer or other sponsor
correspond to the specified performance data,
2. any side effects that occur under normal conditions of use according to type, severity and
Frequency in order to determine whether this taking into account the given
Services represent acceptable risks or
3. Determine mechanisms of action and suitable clinical areas of application of the medical device,
to investigate the safety and effectiveness of the medical device.
(2a) "Performance evaluation test" is a systematic examination of an in vitro diagnostic medical device in
medical laboratories or other suitable facilities on samples from test participants,
including blood and tissue donations, with the aim of
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 under normal conditions of use by the manufacturer or other sponsor
correspond to the specified performance data,
2. any risks arising under normal conditions of use in terms of type, severity and frequency
With regard to determining whether this is acceptable taking into account the specified services
Represent risks or
3. Possibilities of detection and suitable medical fields of application of the in vitro diagnostic medical device
determine,
to investigate the safety and performance of the in vitro diagnostic medical device.
(2b) "Clinical data" is safety or performance information that results from the use of a
Medical device and come from the following sources:
1. clinical trials of the medical device in question, or
2. clinical trials or other studies reproduced in the scientific literature
about a similar medical device, its similarity to the medical device in question
can be demonstrated, or
3. Published or unpublished reports of other clinical experience with either
the relevant medical device or a similar medical device, the similarity with
the medical device in question can be proven.
(3) "Medical device intended for clinical trials" is any medical device that is intended to
a physician qualified in the respective field to conduct clinical trials
Medical product on humans according to paragraph 2 in one of the intended medical
Appropriate medical environment to be made available.
(3a) "In vitro diagnostic medical device for performance evaluation purposes" is any in vitro diagnostic medical device that is dated
Manufacturer is destined to pass one or more performance assessment tests in medical laboratories
Analyzes or in another appropriate environment outside of the company's premises
to become.
(4) "Clinical investigator" is the doctor or dentist who is responsible for carrying out the clinical trial and
is responsible in particular for the well-being of the candidate.
(5) "Sponsor" is any natural or legal person who is responsible for planning the
Initiation, implementation and funding of a clinical trial takes over. The sponsor must be in
a contracting party to the EEA. The clinical investigator has the duties and the
Sponsor to assume additional responsibility if he / she is conducting a clinical trial independently of
Manufacturer of the medical device and carried out under their own responsibility.
(6) "Monitor" is a person designated by the sponsor who is responsible for monitoring and
reporting on the progress of the clinical trial is responsible.
(7) “Clinical trial plan” or “Protocol” is a document that provides detailed information on the reasons,
Intentions, goals, execution as well as planned analyzes, methodology and implementation of the clinical
Exam contains.
(7a) "Evaluation Plan" is a document that provides detailed information about a planned
Performance evaluation test, especially with regard to the scientific, technical and
medical justification, the objectives, the methodology, the intended analyzes and sampling, the
testing performance criteria and requirements as well as the type and scope of the intended evaluation
contains.
(8) "Examiner" is either a patient or a healthy subject participating in a clinical
Test or takes part in a performance evaluation test of an in vitro diagnostic medical device.
(9) “Ethics Committee” is an independent body composed according to Section 58 (4)
medical experts and other members whose job it is to assess whether a
there is a scientifically adequately substantiated clinical trial and whether the safety of that
Wellbeing, the rights and integrity of test takers are protected.
(10) "Clinical Trial Final Report" or "Final Report" is a complete description and
Evaluation of the clinical trial after its completion.
(11) “Multicentre trial” is a clinical trial that corresponds to a single clinical trial
Test plan, but is carried out at several examination sites.
(12) "Case report scheme" or "test sheet" is a set of documents designed in such a way that all
relevant patient and medical device related data required by the clinical trial plan
are fully documented.
(13) “Audit” is the comparison of the raw data and the corresponding records with the intermediate
or final report to determine whether the raw data have been correctly reported and evaluated and the
clinical trial was conducted in accordance with the study plan. An audit must go through either
an internal sponsor unit that operates independently of the clinical unit
Research is responsible, or be carried out by an external scientific institution.
(14) "Inspection of a clinical trial" is one by the responsible ethics committee, the Federal Office
for safety in healthcare, by an expert commissioned by this or by a
foreign health authority carried out check at the test center or at the sponsor who the
Compliance with the provisions of this federal law or other regulations on the clinical investigation of
Medical devices checked.
(14a) "Inspection of a performance evaluation test" is one by the Federal Office for Security in the
Health care, an expert commissioned by this or by a foreign
Health agency conducted review of a performance assessment review that required adherence to
Provisions of this federal law or other provisions on the performance evaluation of in vitro
Diagnostics checked.
(15) “Adverse event” is any adverse clinical event in a clinical event
Exam participants included, regardless of whether it is related to the exam
or performance-rated medical device stands or not.
(16) An event or a side effect within the meaning of Section 2 (17) is to be classified as serious if
that is fatal or life threatening, causes permanent damage, or requires inpatient treatment or
Extension of the inpatient stay is necessary. Any undesirable event or any
Medical device side effect, the damage to a fetus, its death or a congenital
Malformation or the appearance of a malignant tumor are in any case considered to be serious
classified.
Section 3
Differentiation from other regulations
Exceptions to the scope
§ 4. (1) This Federal Act does not apply to
1. Medicinal products within the meaning of the Medicinal Products Act (AMG), Federal Law Gazette № 185/1983, in accordance with Section 5
the decision as to whether a product falls under the AMG or this federal law is made
especially due to the main mode of action of the product,
2. cosmetic products within the meaning of § 5 of the Food Act 1975, Federal Law Gazette № 86, (note: from
January 21, 2006: Food Safety and Consumer Protection Act - LMSVG, BGBl. I No. 13/2006)
3. human blood, blood products, blood plasma or blood cells of human origin or products,
blood products, blood plasma or blood cells of this type at the time of placing on the market
included, with the exception of in vitro diagnostics and medical devices within the meaning of § 2
Paragraph 5c,
4. Organs, tissues or cells of human origin as well as products containing tissues or cells
contain human origin or were obtained from such tissues or cells, be it
because they are in-vitro diagnostics or medical devices according to § 2 Paragraph 5c,
5. Transplants, tissues or cells of animal origin unless a medical device is used
Use of killed animal tissue or products made
were obtained from animal tissue or are in-vitro diagnostics,
6. Natural healing deposits and products from a natural healing deposit within the meaning of Section 42a
Paragraph 2 of the Federal Act on Hospitals and Health Centers, Federal Law Gazette No. 1/1957.
(2) This Federal Act does not affect the 1994 Industrial Code, Federal Law Gazette No. 194.
§ 4a. (1) Medical devices according to Directive 93/42 / EEC, which are also used by the manufacturer
determined according to the regulations for personal protective equipment of the directive 89/686 / EEC
are also subject to the provisions of this federal law.
(2) Medical devices according to directives 90/385 / EEC and 93/42 / EEC, which are also machines in the sense
of Article 2 letter a of Directive 2006/42 / EC are subject to the provisions of this
Federal law.
Differentiation from drug regulations
Section 5
are to apply a drug within the meaning of the drug law, are subject to this federal law
without prejudice to the provisions of the Medicinal Products Act relating to medicinal products.
(2) Is a combination of medical device and medicinal product placed on the market in such a way that
Medical device and drug form a single, interconnected product, the
main intended effect is based on the abusive composition of the drug and that
is intended for use in this connection only and is not reusable
this product the drug law. The Federal Office for Safety in Health Care has at
Assessment of the medical device part the basic requirements according to the II
Federal law to apply, insofar as safety and performance-related medical device functions
are affected.
(3) Contains a medical device - with the exception of in vitro diagnostic medical devices - as an integrated component
Sto ff, which - used separately - as a medicinal product within the meaning of the Medicinal Products Act and in addition to
the medical device can have an effect on the human body, it is a
Medical device in the sense of this federal law.
(4) If a medical device contains a derivative of human blood as part of Section 2
Paragraph 5c, this medical device is also subject to this federal law.
Approval procedure
§ 5a. (1) The Federal Office for Safety in Health Care has at the request of a manufacturer or
its authorized representative in the event that a product is intended to be placed on the market for the first time
to determine whether this product fulfills one of the definitions according to § 2 Paragraphs 1 to 6 and, if necessary, via
to decide on the classification and classi fi cation of the medical device. The manufacturer or
whose authorized representative is domiciled in Germany. As part of this procedure, there may be an opinion
Obtain the delimitation and classification advisory board in accordance with § 5b.
(2) The Federal Office for Safety in Health Care may also make determinations in accordance with para
carry out for office. The delimitation and classification advisory board can also provide an expert opinion
obtain according to § 5b.
(3) The costs for expert opinions are to be borne by the applicant.
Delimitation and classification advisory board
§ 5b. (1) To advise the Federal Minister of Health and the Federal Office for Safety in the
Health care in questions of the delimitation of medical devices from other products as well as
Preparation of expert reports on whether a product fulfills one of the definitions according to § 2 Paragraphs 1 to 6 and
if necessary via the classification of the medical device, is in the Federal Ministry of Health
Advisory Board (delimitation and classification advisory board).
(2) In order to clarify delimitation questions from medical devices to medicinal products, the Advisory Board must
Paragraph 1 in a joint meeting with the Commission (delimitation advisory board) in accordance with Section 49a AMG.
(3) The Federal Minister of Health has technically suitable persons as permanent members for the
To be ordered for a period of five years. When it comes to the composition, care should be taken that a
balanced composition with regard to those that can be delimited and classified
Products or product groups is guaranteed.
(4) The deliberations of the delimitation and classification advisory board can, depending on the type of
subject to be treated in individual cases as non-permanent members
People are involved.
(5) The Federal Minister of Health has one of his employees for the period specified in paragraph 3
Ministry to chair the delimitation and classification advisory board.
(6) A deputy must be appointed for each member and the chairman.
(7) All members as well as the chairman and their deputies have a casting vote.
Representatives have such a right to vote only if the persons they represent are prevented.
(8) The work of the delimitation and classification advisory board is carried out by the Federal Minister for
Health led by rules of procedure.
(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 delimitation and classification advisory board, their deputies
and consulted experts according to the highest fee level of the travel fee regulation 1955, BGBl.
No. 133 to replace on request.
(10) The members of the delimitation and classification advisory board, which are appointed by the Federal Office for
Health care was entrusted with the preparation of relevant expert reports
adequate compensation in terms of effort and time, which the
Applicant has to bear.
II. MAIN PIECE
Section 1
Medical device requirements
Requirements for placing on the market and commissioning
§ 6. It is forbidden to place medical devices on the market, to set them up, to install them, to put them into operation
take or apply if
1. there is reasonable suspicion that they meet the basic requirements within the meaning of sections 8 and 9
and a regulation according to § 10 or, if applicable, does not meet the requirements of § 11 or
2. their expiry date has passed.
Section 7. (1) Medical devices may only be placed on the market and in facilities in accordance with Section 112
of the healthcare system can be put into operation if the for the first placing on the market
Responsible for its seat in a party to the Agreement on the European Economic Area
Has.
(2) The provisions of section 6 (2) and (1) do not apply to the armed forces when deployed in accordance with section 2
Paragraph 1 lit. a of the Wehrgesetzes 2001, BGBl. I № 146, as well as in the immediate preparation of this
Insert.
basic requirements
§ 8. (1) Medical devices must be designed and manufactured in such a way that their use does not comply with the
clinical condition or patient safety still endangers the safety of users or third parties,
if they are used under the intended conditions and for the intended purposes.
Any risks and side effects that may result from proper installation, implantation or
Application may need to be considered taking into account the effectiveness of the medical devices
be defensible to the state of the medical sciences and technology and the protection of health
and security must be guaranteed.
(2) Medical devices must be designed, manufactured and packaged in such a way that they are suitable for use by
Manufacturer to provide specified medical services in accordance with § 2 paragraph 1 or 5 if they
Are exposed to loads under normal conditions of use and under those of the manufacturer
provided transportation and storage conditions may occur.
(3) The design and construction of medical devices must take into account the
generally recognized state of science and technology according to the principles of integrated
Straighten security. When choosing the most appropriate solutions for design and construction are in the
apply the following principles in the order specified:
1. Elimination or minimization of risks by integrating the security concept into the
Development and construction of the medical device,
2. If necessary, taking appropriate protective and alarm devices against constructively not
eliminating risks,
3. Educate users about the residual risks for which there are no adequate safeguards
can be hit.
(4) Medical devices in accordance with Section 4a (1) must also include the relevant basic health
and meet the safety requirements of Directive 89/686 / EEC.
(5) If there is a relevant risk in the case of medical devices within the meaning of Section 4a (2),
these also meet the basic health and safety requirements in accordance with Annex I of the Directive
2006/42 / EG, provided these meet basic health and safety requirements
are more speci fi c than the basic requirements according to the respective Annex I of the guidelines
90/385 / EEC or 93/42 / EEC.
§ 9. (1) Every medical device must be provided with information that takes into account the
Training and knowledge of the intended user group for the safe use of the
Medical device are required. This information must include information in the labeling and
in accordance with paragraph 3 exist in the instructions for use.
(2) The information required for safe use must be on the medical device itself,
be indicated on the unit pack and, if applicable, on the retail pack. If one
Individual packaging is not possible, the information must appear on accompanying information. The
Federal Minister of Labor, Health and Social Affairs can in accordance with § 10 in accordance with the regulation
Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC with regard to the practicability and adequacy of the
Attach or provide this information and to ensure safe use
provide exceptions for medical devices.
(3) Each medical device must be accompanied by instructions for use in its packaging. A
Instructions for use are for class I and class IIa medical devices within the meaning of the directive
93/42 / EEC or for in vitro diagnostics within the meaning of Directive 98/79 / EC in duly justified cases
then dispensable if the proper and safe use of the medical device without
Instructions for use is guaranteed.
(4) The labeling of medical devices and, according to paragraph 3, their instructions for use
must have the manufacturer's name or company name and address.
(5) If medical devices fall within the scope of the Agreement on the European
The economic area must be introduced in order to be placed on the market there for the first time
Labeling, if necessary the outer packaging or the instructions for use, further
the name or company name and the address of the person responsible for placing the product on the market for
in vitro diagnostics from the authorized representative, provided that this is not identical to the manufacturer.
(6) Medical devices may only be given to the user or consumer if they are for him
or certain information is written to the patient in German. The Federal Minister for
Health and consumer protection can be ensured by taking into account a sufficient regulation
Information for patients and users and taking into account the guarantee of the
Medical device safety Allow exceptions to the requirement of the German language or regulations
about the admissibility of suitable measures other than the package leaflet for informing the
Provide users or patients.
§ 10. The Federal Minister of Health and Women has with regard to ensuring the
medical services of medical devices according to § 2 and with regard to the protection of health
and safety of patients, users and, if applicable, third parties and the prevention of risks
Ordinance to define the basic requirements for medical devices.
Requirements for medical devices for in vitro diagnosis
Section 11. (1) Medical devices for in-vitro diagnosis may be without prejudice to Sections 6 to 9 and one
Ordinance pursuant to Section 10 only placed on the market, set up, put into operation and applied,
if, in addition, the requirements according to paragraph 2 and a regulation according to paragraph 3 are met.
(2) Medical devices for in vitro diagnosis must be designed and manufactured so that they can be used under
Consideration of the generally recognized state of the art for the one specified by the manufacturer
Purpose according to § 2 paragraph 5 are suitable. You need the performance parameters, especially in
With regard to the sensitivity, specificity, precision, accuracy, reproducibility specified by the manufacturer
and detection limits. The traceability of the calibration substances or devices
Values ​​attributed to or control materials must be available through available parent
Reference measurement methods and reference materials can be guaranteed.
(3) The Federal Minister of Health and Consumer Protection may use medical devices for in vitro
Diagnosis, insofar as this is in view of ensuring the medical performance of such
Medical devices according to § 2 paragraph 5 and with regard to the protection of health and safety of
Patients, users and third parties and the defense against risks is required by regulation
Define safety and performance requirements. He can also refer to relevant
harmonized or other national or international standards.
(4) In the removal, collection and use of tissues, cells and human impacts
Dignity comes from the production, application and use of in vitro diagnostic medical devices
and to protect human integrity and privacy. With regard to corresponding
Diagnostic measures is the confidentiality of personal data Art. 4 Z 1 of the Regulation (EU)
2016/679 for the protection of natural persons when processing personal data, for free
Traffic and repealing Directive 95/46 / EC (General Data Protection Regulation), OJ No. L 119 dated
May 4, 2016 p. 1 through appropriate precautions and discrimination on the ground
genetic systems not allowed.
statutory authorizations
§ 12. Regulations in accordance with § 10 and § 11 paragraph 3 are, as far as it concerns the electrical safety and the
of the measurement and calibration law, Federal Law Gazette № 152/1950, covers measuring functions of medical devices, in
To be agreed with the Federal Minister for Economic Affairs.
Section 2
Harmonized standards
§ 13. (1) To the extent that harmonized standards within the meaning of this Federal Act are observed, this is
assume that the respective provisions of this federal law will be complied with, unless it
the cases of section 14 or section 77 apply.
(1a) The manufacturers must comply with the Common Technical Speci fi cations. Come in
duly substantiated cases do not follow these speci fi cations, they must choose solutions that meet the requirements
Level of specifications are at least equivalent.
(2) The Federal Minister of Health and Women has the sites of the relevant national
harmonized standards, the relevant monographs of the European Pharmacopoeia and the
Announce relevant Common Technical Specifications in the Federal Law Gazette.
§ 14. The Federal Minister of Labor, Health and Social Affairs has, if the reasonable suspicion
exists that the harmonized standards and the relevant relevant to them in accordance with § 2 Paragraph 15
Monographs of the European Pharmacopoeia and Common Technical Speci fi cations, the
do not meet the basic requirements in the sense of sections 8 and 9 and a regulation in accordance with section 10,
in addition to any necessary measures in accordance with sections 68, 75 or 77, those in accordance with the guidelines
90/385 / EEC, 93/42 / EEC and 98/79 / EC procedures therefor provided for at Community level
initiate.
Section 3
CE marking
§ 15. (1) Medical devices with the exception of custom-made products, medical devices according to § 32, for
clinical testing of certain medical devices as well as in vitro diagnostics for
Performance evaluation purposes may only be placed on the market and put into operation if
they with the CE marking in accordance with this federal law or on the basis of the guidelines
90/385 / EEC, 93/42 / EEC and 98/79 / EC issued national regulations of other contracting parties of the
Agreement on the European Economic Area.
(2) Medical devices may only be provided with the CE marking if they can be proven
1. meet the basic requirements within the meaning of sections 8 and 9 and a regulation under section 10,
2. meet any other regulations applicable to medical devices in accordance with § 16 which refer to them
Taking into account their intended purpose, and
3. a conformity assessment prescribed for the respective medical device according to a
Regulation according to § 28, which gives the authorization to carry the CE marking
have been.
(3) The CE marking must be affixed by the person who has issued an ordinance pursuant to Section 28
is intended for this.
Section 16. (1) If medical devices also have to comply with other regulations, the other aspects
regulations and in which the CE marking is also provided is provided with the CE marking
stated that these medical devices also comply with these other regulations.
(2) Is the manufacturer due to one or more regulations within the meaning of paragraph 1 during a
however, the transition period specified there is free to choose the applicable regulations, so with
the CE marking simply states that the medical devices are only those used by the manufacturer
Comply with guidelines. In this case, the numbers of these guidelines, published in the Official Journal of the
European Communities are published in the documents enclosed with the medical devices,
Notes or instructions can be given.
(3) The documents, information or instructions within the meaning of paragraph 2 must be without destroying the
Packaging that guarantees the sterility of the medical device must be accessible.
§ 17. In the event of changes to a medical device that require approval in the form of an addendum to
The notified body may require a certificate of conformity assessment from it
CE marking can only be applied if the manufacturer or his are within the scope of the
Agreement on the European Economic Area
in accordance with an ordinance pursuant to Section 28. An addendum is necessary for changes that the
Conformity of the medical device with the basic requirements within the meaning of sections 8 and 9 and
a regulation according to § 10 or with the prescribed application regulations.
Note for the following provision
Comes into force on June 7, 2000 in accordance with section 114 (2), but already on December 7, 1999 in accordance with section 114 (3).
§ 18. (1) The CE marking is for active implantable medical devices according to Annex IX of the
Directive 93/68 / EEC, for medical devices according to Directive 93/42 / EEC according to Annex XII
Directive and for in vitro diagnostics in accordance with Annex X of Directive 98/79 / EC.
(2) The CE marking must be on the medical device or the sterile packaging on which
Retail packaging and on the instructions for use clearly visible, legible and permanently attached
his. The CE marking does not have to be affixed to the medical device itself if it is too small
is, its nature does not allow this or it is otherwise impracticable or inappropriate. this applies
also with regard to the attachment on the retail packaging.
§ 19. (1) In addition to the CE marking, the
Identification number of the notified body responsible for carrying out the
Conformity assessment procedure in accordance with Annexes 2, 3, 4 and 5 of Directive 90/385 / EEC, the
Annexes II, IV, V and VI to Directive 93/42 / EEC and Annexes III, IV, VI and VII to the Directive
98/79 / EG is responsible for the respective medical device.
(2) Is a conformity assessment for a medical device according to an ordinance according to § 28
CE marking, which does not have to be carried out by a notified body
no identification number of a notified body can be added.
§ 20. Signs or inscriptions that are misleading as to meaning or graphic
Design of the CE marking are not permitted. All other characters
may appear on the medical device, the packaging or the instructions for use for the medical device
provided that they do not affect the visibility and legibility of the CE marking.
Section 21. Custom-made products, medical devices intended for clinical testing, unless section 40 subsection 4
applicable, as well as in vitro diagnostics for performance evaluation purposes may not have a CE marking in the sense
of this federal law. Intermediate products specified by the manufacturer as part of
Custom-made products may be provided with the CE marking if the
The requirements of section 15 (2) are met.
Section 22. (1) The following applies to medical devices that are provided with the CE marking in accordance with Section 15, provided that
this was not refuted, basically the assumption that it meets the requirements of § 15 paragraph 2
correspond.
(2) If there is reasonable suspicion that a CE marking is contrary to this federal law
has been unlawfully attached or is missing in violation of this federal law, the Federal Office of
Initiate appropriate measures of surveillance in accordance with Section 68
carry out or arrange for the necessary evaluations and investigations or the person or
Organization that manufactures or places the medical device on the medical device by
a notified body, an otherwise suitable accredited body or an expert
to let him present the reports and results to the legality of the attachment or the
Clarify the absence of the CE marking. The bodies or experts are in agreement with the
Federal Office for Safety in Health Care.
(3) The person or facility that manufactures or places the medical device on the market has the costs
monitoring, testing or other measures in accordance with paragraph 2 if the CE
Labeling was wrongly applied or is missing in violation of this federal law.
§ 23. (1) The Federal Office for Safety in Healthcare determines that the CE marking
was improperly attached or is missing in violation of this federal law or evidence in accordance with
15 para. 2 have not been taught within a reasonable period of time, so is the manufacturer or his
Authorized representative, without prejudice to Section 77, is obliged to commit the further violation under the conditions of the Federal Office for
Preventing healthcare safety from conditions stipulated.
(2) If the conditions in accordance with paragraph 1 are not met, the Federal Office for Security in
Healthcare in accordance with the procedure of Section 77 to take all appropriate measures to
Restrict, prohibit or ensure that the product concerned is placed on the market,
that it will be taken off the market. The manufacturer or his authorized representative have these measures
to follow immediately.
§ 24. Is a medical device that does not comply with this federal law or is another
Unlawfully provided the product with the CE marking in accordance with this federal law
Federal Minister of Labor, Health and Social Affairs vis-à-vis those who have the CE marking
has applied, without prejudice to Section 77, the measures required to produce the correct
Condition and to take into account the provisions of Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC
Initiate proceedings.
Section 4
Classification and conformity assessment
Classification of medical devices
§ 25. The Federal Minister of Health and Consumer Protection has ordinance with regard to
the intended purpose, the technology used and the location, type and duration of the
Medical devices taking into account the relevant legal acts of the European Communities
1. Specify those classes that medical devices in particular with regard to
Conformity assessment can be assigned, and
2. to define the criteria and rules according to which medical devices are to be assigned to the classes according to Z 1
are.
§ 26. Exists between a manufacturer and a notified body within its scope
Federal law as part of a conformity assessment procedure with regard to the classification of a
Medical device based on the classification rules according to a regulation according to § 25 none
Agreement, so the notified body has the decision of the Federal Office for Security in the
To apply for healthcare.
European delimitation, classification and derogation clause
Section 26a. If the Federal Minister of Health has referred to the Advisory Board in accordance with Section 5b of the Statement,
that in accordance with technical progress and the information available on the basis of § 70
Adjustment of the classification rules in accordance with Annex IX of Directive 93/42 / EEC is required, he can
Submit a sufficiently reasoned application to the European Commission and request that the
to take necessary measures to adapt the classification rules.
§ 26b. The Federal Minister of Health has given the European Commission sufficient
submit a reasoned request and ask them to take the necessary action if it is after
Referral to the Advisory Board in accordance with Section 5b believes that
1. the application of the classification rules in accordance with Annex IX to Directive 93/42 / EEC
Decision on the classification of a specific medical device or a specific one
Medical device category required, or
2. a specific medical device or a specific series deviating from the provisions in
Annex IX to Directive 93/42 / EEC is to be classified in another class, or
3. the conformity of a medical device or a series deviating from Article 11 of the
Directive 93/42 / EEC or in derogation from Article 9 of Directive 90/385 / EEC in exclusive
Application of a specific procedure to be determined, which results from the Article 11 of the
Directive 93/42 / EEC or from the procedures provided for in Article 9 of Directive 90/385 / EEC
is to be selected, or
4. A decision is required as to whether a particular product or a particular one
Product group under one of the basic terms in Article 1 Paragraph 2 lit. a to e of
Directive 93/42 / EEC or under one of the basic provisions in Article 1 paragraph 2 lit. a, c, d or e
Directive 90/385 / EEC, or
5. The list of products listed in Annex II to Directive 98/79 / EC is changed or expanded
should, or
6. the conformity of a product or a product group deviating from the provisions of
Article 9 of Directive 98/79 / EC using one or more alternative procedures
should be determined from the procedures provided for in Article 9 of Directive 98/79 / EC
were selected.
conformity assessment
§ 27. Medical devices may only be placed on the market or put into operation if their
Conformity with the provisions of this federal law in accordance with a regulation according to § 28
was evaluated.
§ 28. (1) The Federal Minister of Health and Consumer Protection has considered the
Relevant legal acts of the European Communities by regulation more detailed regulations on the
Make conformity assessment of medical devices.
(2) This Ordinance shall specify in particular:
1. Type, design and implementation of the conformity assessment procedures including the respective
Declarations of conformity to be issued and the conditions for affixing the CE
Labelling,
2. the assignment of the conformity assessment procedures to the individual classes of medical devices,
3. Which conformity assessment procedures by a notified body and which by the manufacturer
are to be carried out
4. those conformity assessment procedures which may be initiated by the authorized representative
can be
5. the storage and availability of documents related to
Conformity assessment procedures,
6. the more detailed conditions under which an exemption according to § 32 is granted
can, as well as Art. Content, implementation and handling of the relevant applications,
7. Art. Content and requirements of the declarations to be issued for custom-made products and Art
and content of the documentation to be made available for the responsible authorities,
8. Art. Content, availability and transmission of records of custom-made products that are in
Placed on the market or put into operation,
9. Which conformity assessment procedures may have to be carried out if medical devices
are manufactured or put into operation in healthcare facilities.
(3) The Federal Minister of Health and Consumer Protection may, in an ordinance pursuant to para. 1,
as far as it is in the interest of a uniform and proper implementation of the conformity assessment
and the procedure for placing systems, treatment centers and the on the market
Sterilizing CE-marked medical devices according to the relevant guidelines of the
The European Union also serves to stipulate:
1. the procedure for different interpretations of the provisions of this federal law
concerns the conformity assessment of medical devices within the scope of
Conformity assessment procedures,
2. More detailed regulations on the recognition of intermediate examinations within the framework of
Conformity assessment procedures,
3. the procedure for the conformity assessment of medical devices according to § 5 paragraphs 3 and 4,
4. the procedure for submitting applications to extend decisions of
notified bodies within the framework of conformity assessment procedures and
5. the procedure for systems and treatment units as well as for the sterilization of
Medical devices according to §§ 33 to 35 including the explanations required for this.
(4) The Federal Minister of Health and Consumer Protection can, provided this is with regard to the
Protection of the health and safety of patients, users and third parties or the defense of significant
Risks is required through regulation conformity assessment procedures for medical devices for the
Prescribe vitro diagnosis as a prerequisite for placing on the market and commissioning and their
Specify the content and implementation in more detail.
Section 29. (1) Sets the conformity assessment procedure in accordance with an ordinance pursuant to Section 28 (1) or
the procedure according to §§ 33 to 35 the participation of a notified body in advance, the
Manufacturer or his authorized representative to a body of his choice designated for the fulfillment of these tasks
turn. The simultaneous referral of several notified bodies within one
Conformity assessment procedure for a medical device by the manufacturer or his authorized representative
is not permitted.
(2) In the conformity assessment procedure for a medical device, the manufacturer or the
Notified body to take into account the results of assessments and tests that may be included in
an intermediate stage of manufacture according to this federal law or other Austrian
Regulations within the meaning of Section 112 (1) and (2) have been made.
(3) The notified body is at its reasonable request all information or information
to be submitted or made available for issuing the certificate of conformity and
Maintenance of the conformity decision with regard to the chosen procedure are required.
(4) The documents and correspondence regarding the procedures for conformity assessment are
if they are carried out within the scope of this federal law, in German
or in another official language of a contracting party to the Agreement on the European
Economic area recognized by the notified body.
(Note: Paragraphs 5 to 7 repealed by Federal Law Gazette I No. 119/2003)
custom made
§ 30. (1) For each custom-made product, the manufacturer or his in the European Economic Area
authorized representative before placing on the market for the first time in a regulation pursuant to § 28
issue the intended declaration and make the documentation listed there available. From the
Documentation must include the design, manufacture and performance data of the medical device
including the intended performance, in such a way that it enables an assessment of whether
has met the requirements of this federal law.
(2) The manufacturer must take all necessary measures to ensure that the
Compliance of the manufactured medical devices with the documentation according to a regulation
§ 28 is ensured. He has an assessment of the effectiveness of these measures or, if necessary, one
Allow formal review (audit).
(3) The Federal Office for Safety in Health Care can report all of the manufacturer
Require custom-made products in accordance with Directive 93/42 / EEC, within the scope of this
Federal law have been put into operation or placed on the market.
Section 5
Exhibit; Exemptions in the interest of health protection; Systems and
Treatment units; Sterilization for placing on the market
Exhibit
Section 31. (1) Medical devices that do not comply with sections 15 and 27 may then
Demonstration purposes, especially at trade fairs, exhibitions, demonstrations and scientific
or medical technology events are issued if there is a visible sign on it
indicates that these medical devices are only placed on the market and put into operation for the first time
if their compliance with this federal law is established. At demonstrations they are
take necessary precautions to protect people.
(2) When issuing in vitro diagnostics, it must also be ensured that these products
not on samples originating from participants or otherwise taken during the exhibition
be used.
Exemptions in the interest of health protection
Section 32. (1) Notwithstanding Sections 15 and 27, the Federal Office for Safety in Health Care
on request the placing on the market and the commissioning of individual medical devices for which the
Conformity assessment procedures according to a regulation according to § 28 were not carried out, only in
Allow Austria if their use is necessary in the interest of health protection.
(2) The Federal Minister of Health and Consumer Protection has through the regulation in accordance with § 28
considering an adequate supply of safe and efficient medical devices
and the availability of equivalent medical devices, for which the procedures according to §§ 15 and 27
have already been carried out to determine the more specific conditions under which the
Exemption according to paragraph 1 can be granted, including the type and content of the applications and the
the documents to be attached in accordance with paragraph 1.
(3) When deploying the Federal Army in accordance with Section 2 (1) lit. a of the Wehrgesetzes 2001 and at
Immediate preparation of this deployment is for placing on the market and commissioning individual
in this case of medical devices required an exemption according to paragraph 1 is not required.
(4) An exemption within the meaning of paragraph 1 is not required if a in Austria for
Self-employed professional authorized doctor confirms that a medical device is for a specific
Patients to avert a life threatening or a serious health impairment
is necessary and the success of treatment with a medical device, in which the procedure according to §§ 15
and 27 have already been carried out, are unlikely to be achieved.
Systems and treatment centers; Sterilization for placing on the market
Section 33. (1) Any natural or legal person, each with a CE marking
Medical devices of the directive 93/42 / EEC according to their purpose and within the
Application restrictions provided by the manufacturer are put together in the form of a system or
Placing a treatment unit on the market for the first time must provide an explanation of the content
have ready that
1. the mutual compatibility of medical devices according to the instructions of the manufacturers
checked and carried out the work steps according to the instructions,
2. it packs the system or the treatment center and pertinent user instructions,
including the relevant instructions from the manufacturer, and
3. the entire activity has been suitably monitored and controlled internally.
(2) Are systems or treatment units with medical devices of Directive 93/42 / EEC, the
do not have a CE marking within the meaning of this Federal Act or for the first time in a type and form in
Placed on the market that are not the original purpose and those provided by the manufacturer
If the application restrictions are met, the system or the treatment center becomes independent
Medical device treats and as such is subject to the provisions provided for it
Ordinance in accordance with section 28 (1) and the procedures laid down therein.
§ 34. Any natural or legal person, the systems or treatment units according to § 33 or
other medical devices of Directive 93/42 / EEC with CE marking, for which the manufacturer issues a
Sterilization provided before their use, sterilized for first placing on the market, must be one
apply the procedures referred to in Annexes II or V to Directive 93/42 / EEC. The application of this
Appendices and the involvement of the notified body are relevant to the aspects of the sterilization process
Achievement of sterility of the medical device limited to opening or damage to the packaging.
The person or company must have a statement ready stating that the sterilization
according to the manufacturer's instructions.
Section 35. (1) Medical devices within the meaning of Section 33 (1) and Section 34 may not be accompanied by an additional CE
Labeling. You must provide information in accordance with section 9 and a regulation in accordance with section 10
may be attached, which may also be those of the manufacturers of the composite medical devices
included instructions included.
(2) The explanations for the medical devices listed in paragraph 1 are for monitoring by the
Federal Office for Safety in Health Care and the experts commissioned by it for five years
long available.
Section 6
Notified bodies
designation
Section 36. (1) The conformity assessment procedures in accordance with an ordinance pursuant to Section 28, those designated by
Positions must only be carried out by bodies that are European
Commission and the other parties to the Agreement on the European Economic Area
for which have been named and which are listed in the Official Journal of the European Communities in the Directory of
notified bodies, stating their identification number and the tasks for which they have been designated
are.
(2) The Federal Minister of Health and Consumer Protection can apply relevant domestic
Certi fi cation bodies with the appropriate expertise at their request for the implementation of certain
Tasks in connection with the procedures according to § 28 for certain medical devices or
Name medical device groups if they are approved by the Federal Minister for Economic Affairs for
the implementation of these tasks as a certification body and as a testing or inspection body in accordance with
the Accreditation Act, Federal Law Gazette № 468/1992, are accredited, whereby it must be taken into account that the
Criteria of § 37 are met.
(3) From the bodies that meet the criteria set out in the relevant harmonized standards
correspond, it is assumed that they meet the minimum criteria set out in paragraph 2.
(4) The Federal Minister of Health and Consumer Protection has the appointment of a position
revoke it if it determines that the position no longer meets the criteria of paragraph 2, or restrict it,
if he determines that they meet the requirements of paragraph 2 with regard to certain tasks, procedures
or medical devices or product groups no longer met.
(5) The Federal Minister of Health and Consumer Protection has the other contracting parties of the
Agreement on the European Economic Area and the European Commission on designations
in accordance with paragraph 2 and about the revocation or the restriction of a designation in accordance with paragraph 4 in
To put knowledge.
Minimum criteria for notified bodies
Section 37. (1) The notified body, its manager and that by carrying out the assessments and tests
Commissioned personnel must be independent of the body responsible for the medical device to be assessed
has developed or constructed, as well as by its manufacturer, distributor, installer or user. they may
neither directly nor as an agent for the development or construction, the manufacture, the sales
or be involved in the maintenance of these products for the applicant. The possibility of one
This does not result in the exchange of technical information between the manufacturer and the notified body
locked out.
(2) The notified body must be capable of all in accordance with a conformity assessment procedure
a regulation provided for in § 28 tasks which are assigned to such a position and for which
it is designated to perceive, be it that these tasks are performed by the notified body itself or be it that it
are carried out in some areas under their responsibility. You must in particular about the staff
dispose of and possess the means necessary to carry out the implementation of the assessments and examinations
associated medical-scientific, technical and administrative tasks required
are. You must have the equipment necessary for the tests and surveillance
however, in some areas operate external facilities if access to them is regulated and their
Suitability is ensured.
(3) The body and the personnel responsible for the examination must include the evaluations and examinations
carry out the required expertise and reliability in the field of medical devices and
regardless of any possible influence, especially of a financial nature, on their assessment or the
Be the results of their test.
(4) If a Notified Body determined after establishing the agreement with the client
If it submits work related to the conformity assessment to a subcontractor
ensure beforehand that the provisions of this section are observed by the subcontractor.
The notified body has the relevant documents to assess the technical competence of the
Subcontractor and on the work carried out by the latter within the framework of this Federal Act on
To be available for inspection by the responsible authorities.
(5) Only parts of conformity assessment procedures to be subcontracted may be smaller
Make up part of the total order. Overall responsibility for carrying out a
The notified body must in any case carry out the conformity assessment procedure.
(6) The personnel responsible for the examinations must meet the following requirements:
1. the necessary basis for the assessments and tests for which the position has been designated
Qualification,
2. Adequate knowledge of the regulations for the tests carried out by him and a
sufficient practical experience in this area and
3. those for carrying out the tests and drafting the certificates, protocols and
Reports, in which the tests carried out are recorded, suitability required.
(7) The independence of the personnel commissioned with the examination must be ensured. The high of
Payments to each examiner may not be based on the number of examinations he has carried out or the number of examinations
Judge the results of these tests.
(8) For cases of liability that may arise from their work, the notified body must:
take out sufficient liability insurance, unless this liability is covered by the Republic
Austria covered.
(9) The notified body has
1. the Federal Ministry of Health on all exhibited, changed, supplemented, suspended,
revoked or refused certificates, and
2. the other bodies designated under Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC
about all suspended, revoked or refused certificates and on request via
certificates issued
to inform. The notified body also has all relevant additional information on request
To make available.
(10) If a notified body ascertains that the relevant requirements of this Federal Act of
Manufacturers have not been met or are no longer met, or a certificate has not been issued
should have been, it takes into account the principle of proportionality
issued, revoked or imposed a certificate, unless the manufacturer
ensures compliance with these requirements through appropriate remedial measures. The
Notified body will inform the Federal Ministry of Labor, Health and Social Affairs if the
Certificates are suspended, revoked or restricted, or the intervention of the
Federal Minister of Labor, Health and Social Affairs could prove necessary.
(11) The notified body has all relevant information and documents available on request
the budgetary documentation to verify compliance with the rules for designated
Make available.
(12) The Federal Minister of Health can issue uniform requirements with a view to ordinance
on the designation, monitoring and activities of relevant notified bodies.
III. KEY PIECE
Section 1
Clinical evaluation and performance evaluation
Section 38. (1) Evidence that the requirements set out in Sections 1 and 2 of Annex I to Directive 90/385 / EEC or
Sections 1 and 3 of Annex I to Directive 93/42 / EEC are relevant to characteristics and performance
Requirements of a medical device are met under normal operating conditions, as well as the
Assessment of undesirable side effects and the acceptability of the benefit / risk ratio,
to Annex I Section 5 of Directive 90/385 / EEC or Annex I Section 6 of the Directive
93/42 / EEC, reference must always be made on the basis of clinical data.
(2) The evaluation of this clinical data, hereinafter referred to as "clinical evaluation", at which
if applicable, relevant harmonized standards have to be taken into account according to a de fi ned and
methodically flawless procedures based on a critical assessment
1. the available relevant scientific literature on safety, performance,
Design features and purpose of the medical device, whereby
a) the similarity of the medical device with the medical device to which the
Get data, and
b) the data is reasonably consistent with the relevant fundamental
Have to prove requirements, or
2. the results of all clinical trials carried out, or
3. Combined clinical data according to Z 1 and 2.
(3) For active implantable medical devices and for implantable medical devices and
Class III medical devices of Directive 93/42 / EEC are to be subjected to clinical trials, if
because the use of existing clinical data is sufficiently proven.
(4) The clinical evaluation and its result must be documented. This documentation or a
A detailed reference to this must be included in the technical documentation for the medical device.
(5) The clinical evaluation and its documentation must be active on the basis of the monitoring
data received after placing on the market are kept up to date. Becomes a clinical
Post-market surveillance as part of the post-marketing surveillance plan
Placing on the market is not considered necessary, this must be justified and documented.
(6) If the manufacturer or his authorized representative deem it unnecessary to provide proof of
Compliance with the essential requirements based on clinical data in the sense of
To lead paragraph 1, such an exception is to be justified accordingly. This justification has on the
Result of risk management and has the peculiarities of the interaction between
Body and medical device, the intended clinical performance and the information provided by the manufacturer
consider. The suitability of evidence of compliance with the essential requirements
Justification of performance, product tests and preclinical evaluation alone must be justified.
(7) Evidence that those listed in Annex I, Chapter A, Section 3 of Directive 98/79 / EC
performance-related requirements of an in vitro diagnostic medical device under normal operating conditions
as well as the assessment of risks and the acceptability of the benefit / risk ratio to which
Annex I, Chapter A, Section 1 of Directive 98/79 / EC, must always refer to
based on performance data.
(8) The evaluation of the performance data in accordance with paragraph 7, hereinafter referred to as "performance evaluation",
where, where appropriate, the common technical speci fi cations and relevant harmonized
Standards have to be taken into account according to a defined and methodically perfect procedure
are based on a critical assessment
1. the available relevant scientific literature on safety, performance,
Design features and purpose of the in vitro diagnostic medical device, whereby
a) the similarity of the in vitro diagnostic with the in vitro diagnostic has to be demonstrated
that the performance data refer, and
b) the performance data reasonably in accordance with the relevant
have to prove basic requirements, or
2. the results of all performance assessment tests carried out, or
3. of published or unpublished reports on other clinical experience with the
concern in-vitro diagnostic or a similar in-vitro diagnostic, the similarity
can be demonstrated with the relevant in vitro diagnostic medical device, or
4. of combined performance data according to Z 1 to 3.
(9) The performance evaluation and its result are to be documented. This documentation or a
Detailed references to this are in the technical documentation on the in vitro diagnostic medical device
take. The performance evaluation and its documentation must be based actively on the from the
Monitoring performance data obtained after placing on the market kept up to date
become.
Section 2
Clinical trial
Purpose of the clinical trial
Section 39. (1) Clinical trials of medical devices may only be carried out if they are the
Correspond to the objective of section 3 (2).
(2) Clinical trials of medical devices may only be carried out if
1. there is sufficient evidence of the fulfillment of the requirements pursuant to Section 41 (4) and
2. Meaningful results of the required non-clinical tests are available, which accordingly
the current state of science.
method
Section 40. (1) The sponsor has the clinical investigations of medical devices in Appendix 6 of the
Directive 90/385 / EEC, in Annex VIII of Directive 93/42 / EEC, for the performance assessment of in-
in vitro diagnostic medical devices apply the procedure listed in Annex VIII to Directive 98/79 / EC.
(2) With the clinical trial of active implantable medical devices in accordance with the directive
90/385 / EEC as well as class III medical devices or implantable or long-term
Use of certain invasive medical devices of classes IIa or IIb according to directive 93/42 / EEC
can be approved by the responsible ethics committee and reimbursed
proper reporting to the Federal Office for Safety in Health Care is started,
provided that the Federal Office for Safety in Health Care is not within a period of 60 days after
proper reporting of the clinical trial, the clinical trial to protect subjects,
public health or due to other non-existence of the requirements of section 41 (4)
prohibited or approved the conduct of the clinical trial before this period.
(3) With the clinical testing of medical devices in accordance with Directive 93/42 / EEC, which is not covered in paragraph 2 and
5, and the performance assessment tests of in vitro diagnostic medical devices according to Directive 98/79 / EC,
that are not mentioned in paragraph 5 can, after a favorable opinion by the responsible
Ethics Committee and reporting a proper report to the Federal Office for Security in the
Healthcare will be started.
(4) The notification to the Federal Office for Safety in Health Care has included in the
to make the declaration mentioned in Paragraph 1. The documentation listed there is on
To provide the request immediately.
(5) With the clinical testing of medical devices in accordance with Directive 93/42 / EEC, which according to § 15 the
If the clinical trial does not indicate a different purpose of the
Medical device as the object of the conformity assessment and the clinical
Testing does not require additional diagnostic or therapeutic measures - after
approval by the responsible ethics committee. With the
Performance assessment testing of in vitro diagnostic medical devices according to the directive 98/79 / EG, which according to § 15 the CE
If the performance assessment test does not indicate any other purpose of the
In-vitro diagnostics as the object of the conformity assessment - after
approval by the responsible ethics committee. Section 47 does not apply.
(6) The sponsor has the Federal Office for Safety in Health Care and the responsible
Authorities of other affected EEA parties to the completion of the clinical trial, in the event of a
early termination with a corresponding reason. This message also sent to the
competent authorities of all other EEA contracting parties and the European Commission
take place if the premature termination occurs for security reasons. The final report according to
Annex 7 section 2.3.7 of Directive 90/385 / EEC or Annex X section 2.3.7 of Directive 93/42 / EEC
is for the Federal Office for Safety in Health Care and the competent authorities of the others
to keep the relevant EEA contracting parties available.
(7) Reports in accordance with paragraphs 1, 2, 3 and 6, § 40b and § 42 paragraph 8 must be in accordance with a
Regulation according to § 67 in the way of the European database for medical devices.
Modification of the test plan
Section 40a. (1) After the clinical trial begins, the sponsor may change the trial schedule. If the
Change is significant and affects in particular the safety of the test participants or the
The sponsor of clinical trials can influence the scientific significance of the clinical trial
Examinations according to § 40 Paragraphs 2 and 3 of the Federal Office for Safety in Health Care and the
report the content of the change and all reasons for it to the responsible ethics committee. In clinical
The sponsor of the responsible ethics committee has the content of the change and
to report all reasons for this.
(2) In the case of a clinical trial pursuant to Section 40 (2), the change can be made after a positive opinion
the responsible ethics committee for a report in accordance with paragraph 1, provided that
Federal Office for Safety in Health Care not within a period of 35 days after
Proper notification of the change to the clinical trial to protect the trial subject
public health or due to other non-existence of the requirements of section 41 (4)
prohibited or approved the implementation of the change before this period.
(3) In the case of a clinical trial pursuant to Section 40 (3), the change can be made after a positive opinion
the responsible ethics committee on a report in accordance with paragraph 1 and reimbursement of the report in accordance with paragraph 1
to the Federal Office for Safety in Health Care.
(4) In the case of a clinical trial in accordance with Section 40 (5), the change can be made after a positive opinion
the responsible ethics committee for a report in accordance with paragraph 1.
(5) Without prejudice to paragraphs 1 to 4, the sponsor and the clinical investigator have each new
Circumstance regarding the course of the examination or the development of the medical device in clinical examination,
which can impair the safety of the test participants or users, the urgently required
Take security measures to protect test takers or users from immediate danger
protect. In the case of clinical trials in accordance with section 40 (2) and (3), you have the Federal Office for
Healthcare security and the responsible ethics committee on these new circumstances and the
measures taken to inform. In the case of clinical trials in accordance with section 40 (5), they must immediately
to inform the responsible ethics committee about these new circumstances and the measures taken.
The notification requirements according to § 70 remain unaffected.
Suspension or prohibition of the clinical trial
Section 40b. (1) Provided the Federal Office for Safety in Health Care has objective reasons for acceptance
has that the requirements of the notification according to § 40 paragraphs 2 and 3 are no longer met, or about
Information that is relevant to the safety or the scientific basis of a
If the clinical trial raises concerns, it must suspend or prohibit the clinical trial.
Before the decision, except in the event of imminent danger (§ 57 AVG), the sponsor and the
to inform clinical investigators. The sponsor must give his opinion within one week.
(2) The Federal Office for Safety in Health Care, provided that it carries out a clinical
Suspends or prohibits review, the other EEA Contracting Parties, the relevant ethics committee,
and the European Commission stating the reasons for its decision to conduct the clinical trial
suspend or prohibit, inform. Has the Federal Office for Safety in Health Care
ordered a significant change in a clinical trial, it has the other contracting parties
of the EEA in whose territory the clinical trial is being conducted, as well as the responsible
To inform the ethics committee about its measures and their reasons.
(3) Does the Federal Office for Safety in Health Care have reasons to believe that the sponsor
or the clinical investigator or any other party involved in the clinical trial does not meet its obligations
more fulfilled, it must inform the concerned person immediately and give him the opportunity to comment
and then inform him of an action plan that he must implement to remedy the situation. This
applies even if the clinical trial has already ended. Obligation to notify according to paragraph 2 remains
unaffected.
general requirements
§ 41. (1) When planning, setting up and carrying out clinical trials, the health
To keep risks and burdens for the test participant as low as possible.
(2) The clinical trial of medical devices may only be carried out if the risks associated with
you are connected to the test participants, measured by the expected meaning of the result of the
Examination for medicine are justifiable and the risk of impairment of the
Health of these subjects
1. is not significant or
2. is outweighed by the benefit to be assumed from the use of the medical device
Health.
(3) The clinical trial of medical devices may only be carried out on patients if the
Application of the medical device according to the knowledge of medical science is indicated to
for the patient on whom the clinical trial is to be carried out, a purpose in accordance with Section 2 (1)
to reach.
(4) The clinical trial of a medical device may only be carried out if all in the
Precautions necessary to protect life related to clinical trial,
the health and safety of the test participants, users or third parties have been taken and
the medical device with the exception of the aspects that are the subject of the clinical trial
basic requirements in accordance with sections 8 and 9 and a regulation in accordance with section 10.
(5) The manufacturer of a medical device intended for clinical trials has all the necessary
Measures to be taken to ensure the conformity of the manufactured items
Ensure medical devices with the documentation according to an ordinance according to § 66. He has one
Assessment of the effectiveness of these measures and, if necessary, an inspection by the Federal Office for
Allow healthcare security.
(6) When planning, creating, executing and evaluating clinical trials of
Medical devices and performance assessment tests of in vitro diagnostic medical devices are ethical
Principles for human medical research of the Helsinki Declaration of World Medical
Association, as amended by the 59th General Assembly of the World Medical Association, Seoul, October
2008, to be observed.
methods
Section 42. (1) The clinical trial is to be carried out according to a trial plan that is state of the art
and technology has to correspond and to create in such a way that the questions and details of the
Manufacturer of the medical device or other sponsor, especially regarding the services and
Answer, confirm or scientifically understandable side effects of the medical device
disprove.
(2) The clinical trial must be for the scientific validity of the conclusions
include sufficient number of observations.
(3) Before and if necessary during the entire course of a clinical trial, starting with
Appropriate statistical methods are to be used and the draft of the test plan up to the final report
Carry out evaluations.
(4) As part of the clinical trial of a medical device, everyone must be responsible for the objective of
clinical examination relevant features of the medical device, including the safety and
performance-related properties and the effects on the patient are examined.
(5) The for the collection of security-related features, benefits and side effects of a
Medical device criteria and test variables must be used with suitable observation and
Measuring methods are determined and with regard to the assessment of the benefit / risk ratio
be meaningful.
(6) The procedure for carrying out a clinical trial must depend on the candidate
Medical device to be adapted.
(7) Clinical trials must be carried out under the intended conditions of use of the medical device
be performed.
(8) All serious adverse events must be fully registered by the sponsor and
immediately to the Federal Office for Safety in Health Care and the competent authorities of the
other relevant EEA Contracting Parties in which the clinical trial is being conducted.
Documentation, documents
§ 43. For each clinical trial are those for the objective, the medical, scientific and
technical basics, planning, organization, implementation and evaluation of the clinical trial
and beyond for the protection of health, safety, integrity and rights of the
Test takers relevant points of view and arrangements in appropriate documentation and
To record documents.
§ 44. In particular, the following documentation and documents must be provided for every clinical trial
and submit it to the Federal Office for Safety in Health Care:
1. the test plan,
2. the clinical investigator's manual,
3. those for the education of the test participants and, if applicable, their legal representatives in accordance with
Section 51 information to be used and the declaration of consent,
4. the provisions for insurance protection within the meaning of sections 47 and 48,
5. The agreements between the sponsor, monitor and clinical investigator, the
Define responsibilities,
6. The opinions of all ethics committees to be dealt with and the points of view that matter
of these comments were, and
7. the final report.
test plan
§ 45. (1) A written agreement between the sponsor and
clinical investigator.
(2) The test plan has the scientifically sound structure and sequence of the clinical test
and their scientific significance with regard to their objectives and questions
sure.
final report
§ 46. (1) For each clinical trial, a written final report is to be prepared, which is available to everyone on the
Clinical investigators involved must be signed.
(2) The final report has received a critical evaluation of all those obtained during the clinical trial
contain scientifically relevant data.
insurance
Section 47. (1) The sponsor has personal injury insurance taking into account paragraph 2
complete that covers all damage to life or health of the subject by the
clinical trial measures carried out on him and for which the
clinical investigators would be liable if they were at fault (§ 1295 ABGB), with the exception of damage
due to changes in genetic material in human germline cells.
(2) Personal injury insurance in accordance with paragraph 1 is based on the following principles
complete:
1. The sponsor has policyholders, the test participant has independent entitlement
To be insured.
2. Austrian law must apply to the insurance contract.
3. The insurance claims must be enforceable in Austria.
4. The enforceability of an Austrian execution title abroad must, if necessary
be secured.
5. The scope of insurance must be proportionate to that with the clinical
Testing related risks; the minimum sum insured is regulated by the
Federal Minister of Health and Consumer Protection.
(3) The test participant and, in the cases of § 51, his legal representative are before the start of the
to inform the clinical trial about the insurance protection in accordance with paragraphs 1 and 2.
Section 48. In the event that the sponsor is not the clinical investigator at the same time, the sponsor must clarify:
if necessary, whether the clinical investigator has sufficient liability and legal protection insurance
the clinical investigator from the increased risk associated with the clinical trial
Appropriate reimbursement of additional costs for own insurance or suitable ones for your own account
Take out insurance for the benefit of the clinical investigator.
Education and consent
Section 49. (1) The clinical trial of a medical device may only be carried out if the
Exam participants by a doctor or dentist about purpose, meaning, scope, benefits, risks and
Of the clinical trial has been cleared and his consent to participate in the
clinical trial.
(2) The information must be sufficiently clear and easily understandable for the test participant, so that
the decision to consent to participation in the clinical trial with full knowledge of the
relevant facts.
(3) The information must be given both verbally and in writing. She has to make it clear
that a refusal to participate in the clinical trial or withdrawal from the clinical trial
Examination at any time without adverse consequences, especially for further medical
Care of the test subject remains. If necessary, the information must also include which ones
medical consequences of withdrawing from the clinical trial at certain times.
(4) The test participants are aware of the purpose and scope of the collection and use
to inform personal data. The test participants are particularly keen on this
point out that data
1. checked by the monitor, during an audit and during an inspection by the authority
can be, and
2. passed on to the sponsor in pseudonymized form.
(5) With the consent to take part in the clinical trial according to § 50 para
obtain explicit data protection consent. The revocation of consent has none
Effects on activities based on informed consent prior to their
Revocation, or on the use of the data collected on this basis. The
Law under Article 17 of the General Data Protection Regulation is excluded. This is in the course of the collection
of consent.
(6) For further processing in accordance with Art. 9 Para. 2 lit. j of the General Data Protection Regulation, Section 2d applies
Paragraph 3 of the Research Organization Act, Federal Law Gazette I No. 131/2015.
§ 50. (1) If a test participant agrees to participate after extensive information, must
his consent must be recorded in writing. The consent must be dated and with the
Signature of the test participant. If the test participant is not in the
Is the consent must be given before a witness who has the consent of his
Has to confirm signature.
(2) Unless otherwise stipulated in Section 51, consent is only legally effective if the
Examiner is able to determine the nature, importance, scope, benefits, risks and burdens of the
to inspect the clinical trial and then determine his will.
(3) Consent to participate in the clinical trial may be withdrawn at any time. Are for
participation in the clinical trial requires multiple consents, so the clinical trial may take place
this person will not be continued if even one of these consents is withdrawn.
(4) The test participants and, if applicable, legal representatives (§ 1034 ABGB) must write to
the insurance cover according to § 47 will be informed.
Protection of certain groups of people
Section 51. (1) The clinical trial of a medical device may only be carried out on minors if
if
1. The medical device that is being tested helps to achieve a purpose in accordance with Section 2 (1)
Minors is intended and clinical trial for the validation of data used in clinical
Examinations on adults or other research methods are essential
is required,
2. the application of the medical device that is being tested according to the knowledge of the medical device
Science is indicated to be given to the minor on whom the clinical trial is being conducted
will achieve a purpose according to § 2 paragraph 1 and the inclusion in the
clinical trial related benefits for the trial subject outweigh the risk
3. the consent of the legal guardian can be proven after appropriate clarification and
was given in writing,
4. The minor before the start of the clinical trial by someone dealing with minors
Experienced clinical investigators should have an understanding appropriate to their ability to understand this
had received,
5. the consent of the minor who is able to understand the essence, the meaning, the
To see the scope and risks of the clinical trial and to determine his will accordingly,
has been demonstrably granted, and it is ensured that the expressly by a minor
expressed desire not to take the clinical trial or take it at any time
to be considered by the clinical investigator
6. The consent can be withdrawn at any time without the minor being affected
Disadvantage arises
7. with the participation in the clinical trial, no incentives or financial benefits
Exception to an expense allowance,
8. the clinical trial is planned so that it takes into account the disease and the
Developmental stage of the minor with as little pain, discomfort, fear and
other predictable risks, including the risk threshold as well as the
Degree of exposure specifically defined and constantly checked,
9. The test plan by an ethics committee that has knowledge in the field of children and
Juvenile medicine or who deals with clinical, ethical and psychosocial issues on the
Had been advised in the area of ​​pediatrics and adolescent medicine, and was approved
10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of
Science stand.
(2) Deviating from Paragraph 1 No. 2, a clinical trial on minors is also permitted if
1. The clinical trial is an essential extension of the scientific understanding of the
Condition, illness or disorder of the minor and thereby either
Can benefit patients or the patient group to which the minor belongs, and
2. The clinical trial for the minor with only a minimal risk and minimal burden
brings oneself; a clinical trial has minimal risk and minimal burden if
it is to be expected that at most it will be a minor and merely temporary
Impairment and any symptoms or inconveniences can be very minor
and will only appear temporarily.
§ 52. The clinical trial may be carried out on a person who is the result of a mental illness or a
comparable impairment of their ability to make decisions has a legal representative or on
judicial or official order stopped or according to the Housing Act, BGBl.
No. 155/1990, is not carried out.
Section 52a. (1) A clinical trial, by its nature, can only be used in emergency situations in which appropriate
Time no consent of the legal representative can be obtained, can be carried out at
a person who is unable to consent to have a clinical trial performed if:
1. There are no indications that either the patient refused the clinical trial
or would reject or the requirements of Section 52 exist,
2. Such research for the validation of data used in clinical trials for consent
have been obtained by persons capable of providing information or using other research methods, and
absolutely necessary for the clinical evaluation of the safety and effectiveness of the medical device
are and can only be carried out in emergency situations,
3. the medical device that is being tested to fulfill a purpose as defined in Section 2 (1)
Z 1 to 3 is determined in an emergency situation,
4. the use of the medical device that is being tested according to the knowledge of the medical
Science is indicated to help the emergency patient
a) to recognize, prevent, monitor, treat or alleviate an illness,
b) identify, monitor, treat, alleviate, or alleviate an injury or disability
compensate, or
c) to examine, change or adapt the anatomical structure or physiological processes
replace,
and the patient benefit associated with inclusion in the clinical trial, the risk
predominates
5. the conduct of the test and the test plan by an ethics committee that has knowledge of the
Area of ​​the disease concerned, in relation to the emergency situation and the affected
Patient group or who deal with clinical and ethical issues in the field of
related illness, in relation to the emergency situation and the affected patient group
, expressly for the conduct of clinical trials in emergency situations on persons who
are unable to give personal consent, have been approved, and
6. In case of doubt, the interests of the patient always outweigh the public interests and the interests of the patient
Science stand.
(2) At the test center where a clinical trial in emergency situations is performed on people who are not in
are able to consent, the public is appropriately informed about this
To inform circumstance.
(3) If the patient becomes able to give consent, he must be informed immediately that a
clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 49 and
50 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
Enlightenment including express consent under data protection law is given. Another
Processing of the data processed up to that point requires the express data protection law
Approval.
(4) As soon as the legal representative's consent can be obtained, it is continued
the clinical trial is only permitted under the conditions of § 51.
(5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
processed data will be used for the purposes of this clinical trial.
Section 53. The clinical trial of a medical device may be carried out on a pregnant or breastfeeding woman
Mother can only be done when
1. the medical device to be tested in order to achieve a purpose in accordance with Section 2 (1)
breastfeeding mothers, pregnant women or unborn children
2. the use of the medical device according to the knowledge of the medical sciences
is indicated to the breastfeeding mother or pregnant woman taking the clinical trial
is carried out, or in the case of her unborn child a purpose in accordance with Section 2 (1)
to reach,
3. according to the knowledge of the medical sciences, the conduct of the clinical trial
is not expected to pose any risks to the unborn or breastfed child and
4. The clinical trial according to the knowledge of medical science only on pregnant women
or breastfeeding mothers can expect adequate test results.
§ 54. The clinical trial of a medical device may be carried out on persons who have a presence or
Provide training or community service, not be carried out.
Dealing with data
Section 55. (1) During the entire course of the clinical trial, everyone involved is
treat patient-related data with strict confidentiality. All patient-related data must be against
unauthorized access is protected and pseudonymized as far as possible, whereby it must be ensured that
that the additional information with which the personal data of an affected person
can be assigned to be kept separately.
(2) Sponsor, monitor and clinical investigator have all appropriate measures for careful and
set confidential handling of all data resulting from a clinical trial.
(3) The study plan, the final report as well as all created in connection with the clinical study
Data and documents are for specific periods after the completion or termination of the clinical trial
to be kept by the Federal Minister of Health and Consumer Protection in a regulation pursuant to
Section 66 are to be laid down. This regulation also specifies who is to be kept for certain
Data or documents hits.
(3a) For the period of the retention periods, the right under Art. 17 data protection
Basic regulation excluded.
(4) All data and documents relevant to the clinical trial must be submitted to the
Federal Office for Safety in Health Care to check compliance with the provisions of this
Federal Act on Clinical Trials will be made available.
Quality control and quality management
§ 56. (1) The sponsor and the clinical investigator have with regard to planning, implementation and
Evaluation of a clinical trial to apply an adequate quality management system that the
complete traceability of all observations and findings, correct collection and processing
data and the correct derivation of conclusions.
(2) An audit initiated by the sponsor must be carried out by bodies or organizational units that
are independent of those responsible for the clinical trial.
(3) Test centers, facilities including laboratories and any kind of data are for one
Review by the responsible ethics committee and for an inspection by the Federal Office for
Healthcare security or by a foreign health authority upon notice
to make it accessible.
(4) The aim of an inspection is to determine, by means of objective, independent verification, whether the in
this federal law prescribed standard with regard to planning, implementation and evaluation
clinical trials are complied with. An ethics committee inspection may also aim to:
by means of an objective, independent review to determine whether the ethics committee is performing its tasks
this federal law in accordance with the state of the art.
(5) Ethics committees are obligated, the Federal Office for Safety in Health Care all
To provide information and to send documents that this to perform its duties under this
Section needed.
(6) If an inspection determines that a clinical trial is contrary to the provisions of this
Federal law is carried out, or arise concerns regarding the safety or the
scientific basis of clinical testing and thereby the life or health of
Exam participants or users are at risk, the Federal Office for Security in
Healthcare measures within the meaning of Section 40b (1), even without a previous procedure or before
Issuing a decision; however, written notification of this is to be given within two weeks
otherwise the measure is deemed to have been lifted.
(7) Developed by the Federal Office for Safety in Health Care on the occasion of an inspection
clinical trial cash expenses are to be charged to the sponsor, unless the clinical
Examiners perform the tasks of the sponsor within the meaning of Section 3 (5).
ethics committees
Section 57. (1) The clinical trial of a medical device may only be carried out if the
Assessment has been obtained from the responsible ethics committee.
(2) In the context of a multicentre examination, a responsible ethics committee can issue the opinion
to another ethics committee responsible for this clinical trial as sufficient. In this
Case, the assessing ethics committee must also announce all of the auditors involved and all of them
Documents are made available that provide an assessment with regard to their professional quali fi cation
and experience, as well as the existing facilities and staff.
Section 58. (1) The governor has with regard to clinical trials outside of hospitals
Ensure that independent ethics committees are responsible in the area of ​​his state
A sufficient number of tasks are performed in accordance with Section 60.
(2) For clinical trials at hospitals, the responsible ethics committee in accordance with § 8c
Hospital Act, Federal Law Gazette No. 1/1957.
(3) The appointment of ethics committees in accordance with paragraph 1 is the Federal Ministry of Health and
Women and the Federal Office for Safety in Health Care display.
(4) The ethics committee must at least consist of:
1. a doctor who is authorized to practice his profession independently in Germany,
2. a specialist in whose specialty is the clinical examination of the medical device,
3. a representative of the nursing service,
4. a lawyer,
5. a pharmacist,
6. a technical safety officer of a hospital,
7. a patient representative,
8. a representative of a representative organization for the disabled and
9. Another person who does not fall under Z 1 to 8 and who is concerned with pastoral care
Is entrusted with matters or otherwise has the required ethical competence. additional
Experts are to be involved as far as the assessment of a clinical trial requires. The
Ethics Committee has to be made up of women and men. Doing so if possible
to pay attention to a balanced relationship. A representative must be appointed for each member. The in Z 1
and 2 listed members of the ethics committee are not allowed to have clinical examiners in the frame
the clinical trial to be assessed.
Section 59. (1) The members of the Ethics Committee and their deputies must perform this function
be free of instructions. You have any relationships with manufacturers or distributors of medical devices
completely open to the governor. They have become active in the
Ethics Committee - without prejudice to any other reasons for bias - in all matters
contain, in which such a relationship is likely to question its full impartiality.
(1a) Internal quality assurance measures shall be provided within the framework of the organization
Ensure in particular the regularity of the processes and procedures.
(2) The implementation of the agendas of the ethics committee and the proper establishment
Its decisions and statements must be set out in writing in the rules of procedure, which of the
Approval by the responsible governor is required.
(3) The sponsor or clinical investigator has all the necessary documents for the ethics committee
Assessment of the clinical trial in accordance with § 43, in particular also evidence of qualifications, the trial plan,
the evidence of the technical safety of the medical device, the preclinical documents, the
Results of the benefit / risk analysis, the materials for the education of the test participants and for the
Obtaining your consent and documents about the insurance in accordance with §§ 47 and 48 and about the
Submit compensation for the participation of the test participants.
§ 60. (1) The responsible ethics committee has in particular based on the submitted documents
judge:
1. the suitability of clinical investigators with regard to their professional qualifications and experience,
2. existing facilities as well as staffing and qualifications,
3. the test plan with regard to the objective of the test, the medical technology and medical
Justification of the examination and with regard to its scientific significance and the
Assessment of the benefit / risk ratio,
4. Selection and recruitment of the test participants as well as clarification and obtaining consent
to participate and
5. the precautions for the occurrence of a claim, particularly with regard to
Insurance taken out in accordance with sections 47 and 48 in connection with the clinical trial
were.
(2) The ethics committee has its opinions with reference to the submitted documents
to be recorded in written form. The opinion on a clinical trial is within
60 days to submit an opinion on a change to the test plan within 35 days and
to be transmitted to the Federal Office for Safety in Health Care at the same time.
(3) The Ethics Committee may review the proper conduct of the clinical trial
protecting the health and safety of test takers and maintaining their integrity and
Check rights through an inspection at the sponsor or at the testing center.
§ 61. The clinical investigator has the ethics committee immediately on all serious
Inform side effects in the clinical trial. The reporting obligations of Section 70 remain
unaffected.
Tasks and areas of responsibility of the people involved in the clinical trial
Section 62. (1) The responsibilities and areas of responsibility of those involved in the clinical trial
Persons, especially the sponsor, clinical investigator and monitor, must be specified in writing and by
to confirm their signatures.
(2) The clinical investigator and the monitor assume the role of sponsor
The sponsor is permitted if this is documented and the respective responsibilities and
Tasks are fully taken over.
Tasks and areas of responsibility of the sponsor
Section 63. (1) The sponsor has the clinical investigator, taking into account his professional quali fi cation,
its availability over the entire period of the study and taking into account suitability and
Availability of local, medical, and clinical trials available to clinical investigators
organizational circumstances and options.
(2) If necessary, the sponsor is responsible for appropriate monitoring of the clinical trial
to care. For this purpose, he has one or more suitably trained and qualified people with the function
to entrust a monitor in accordance with Section 65 or their areas of responsibility and responsibilities themselves
perceive. Furthermore, he has to ensure that, if necessary, internal audits of the study are carried out
can be.
(3) The sponsor has the clinical investigator all for the safe use of the investigated
Medical device and the proper execution of the clinical trial required documents,
including the relevant information that will only become available during the ongoing study on
To provide administrative support, supportive support if necessary
Provide research staff and, if necessary, appropriate training for the clinical investigator
and its employees in the intended and safe installation, preparation and application of the
Medical device and its necessary accessories.
(4) The sponsor must ensure that neither the test participant nor the
Austrian social security institutions or third parties from providing the clinical trial
certain medical device costs, unless
1. the use of which is associated with a primary individual benefit insofar as it serves to ward off one
damage to health or to remedy physical suffering is urgently needed
and compared to available medical devices that are already permitted on the market
seriously increases the chances of success,
2. the social security institution or third parties information about the medical device used and
the clinical trial has been made available and
3. Social insurance institutions or third parties based on these documents after assessing the existence
have agreed to the requirements of sections 1 and 2 of an application for cost coverage.
(5) The sponsor must assess the test plan and confirm it with his signature.
(6) The sponsor may carry out its duties or obligations in whole or in part
delegate to external scientific institutions.
Tasks and responsibilities of the clinical investigator
§ 64. (1) Clinical investigator may only be a suitably qualified, for independent practice of
medical or dental profession in Austria may be a qualified doctor or dentist who
1. is trained and experienced in the area of ​​application of the medical device to be tested and
2. is familiar with the background and requirements of the clinical trial and at least one
can demonstrate two years of experience in clinical trials.
(2) Before the start of the clinical trial, the clinical investigator must have all relevant data and
Documents, in particular with regard to the test plan, the relevant scientific literature, the
preclinical data, the results of previous clinical trials with the medical device, the evidence
about technical security, the documents about structure, composition, functionality,
Properties and performance of the medical device and the instructions for its intended use
Familiarize application thoroughly. The sponsor has access to all of the clinical investigator
to ensure relevant data.
(3) The clinical investigator must ensure that he and his employees also with regard to the
Human resources and the available facilities and medical facilities in
are able to conduct the clinical trial in accordance with this federal law and the trial plan and
complete. This also includes arrangements for emergency measures.
(4) The clinical investigator is responsible for the clarification and information required by this Federal Act
the test participant and, if applicable, their legal representatives and obtaining the necessary
Responsible consent.
(4a) The clinical investigator has for the sponsor the obligations under Art. 13, 15, 16 and 18 of the data protection
To comply with the basic regulation and in the event of violations of the protection of personal data
Notify test takers in accordance with Art. 34 of the General Data Protection Regulation and the sponsor
to inform about it.
(5) The clinical investigator has the sponsor about all medical device side effects and all
to report serious adverse events as part of the clinical trial.
(6) The clinical investigator must sign the test plan and in writing and with his signature
confirm that he is conducting the clinical trial in accordance with the study plan and the provisions of this
Federal law will implement.
(7) The clinical investigator has all employees who are involved in the conduct of the clinical trial or in the
Care of the test participants are involved, all relevant information is available to them
put.
Tasks and areas of responsibility of the monitor
Section 65. (1) The monitor has
1. Establish communication between sponsor and clinical investigator and on behalf of the
To provide sponsors with appropriate monitoring of the clinical trial,
2. Work according to the Standard Working Instructions (SOP) before the clinical investigator
and visit after completing the clinical trial to ensure adherence to the trial plan
check and ensure that all data is correctly and completely recorded and recorded
be, and
3. Compare the entries in the test sheets with the original findings and the clinical investigator
to inform about errors and omissions.
(2) The monitor must have the quali fi cations that enable it to provide expert clinical support
Enable testing.
Section 65a. (1) The provisions of sections 39, 40 subsection 1, 3, 4, 5 and 7, 40a and 40b, 41 to 44, 45 subsection 2, 46 bis
64 also apply to performance appraisal examinations, unless paragraph 2 specifies otherwise.
(2) Unless an after-performance test of an in vitro diagnostic medical device
Type or amount of special sampling from subjects or additional medical
Examinations or treatments are provided or as part of the performance evaluation test
performed in vitro diagnostic or therapeutic consequences for the
Exam participants may have, §§ 47 to 54 do not apply to the performance assessment examination of in-
vitro diagnostics.
statutory authorization
§ 66. The Federal Minister of Labor, Health and Social Affairs has, provided this with regard to the
clinical evaluation, the proper planning, implementation, evaluation and control of clinical
Tests or performance assessments of in vitro diagnostic medical devices with a view to protecting the
Health and safety of test subjects and ensuring scientific
Significance of clinical trials or performance assessment tests appears to be required by regulation
taking into account the relevant legal acts of the European Communities
Regarding provisions
1. The requirements for the clinical evaluation of medical devices, their documentation and their
Implementation, especially in the context of conformity assessment,
2. those types, groups or classes of medical devices, in any case during their clinical evaluation
clinical data are to be used,
3. Further requirements for the planning, implementation and evaluation of clinical
Tests of medical devices or the performance evaluation test of in vitro diagnostics,
4. The tasks and areas of responsibility as well as the quali fi cation of the implementation of the clinical
Examination or people involved in the performance evaluation test,
5. Art. Content, scope and design of the for the conduct of the clinical trial or
Performance assessment test required documents, in particular the test plan, the
Evaluation plan, the manual of the clinical investigator, the final report, the documents
for the clarification and obtaining consent, as well as about statistical planning, analysis
and evaluation and storage of data and documents,
6. quality management in the context of the clinical trial or the performance assessment test,
7. Art. Content, scope and implementation of the notification, declaration and documentation in accordance with § 40,
8. Minimum requirements for insurance in accordance with sections 47 and 48 as well
9. Assumption of conformity with provisions on the clinical trial of medical devices or the
Performance assessment testing of in vitro diagnostics with regard to relevant harmonized
standardize
set.
IV. MAIN PIECE
Section 1
Registration of manufacturers, distributors, test centers and users
Section 67. (1) Who is responsible for the initial placing on the market of medical devices in accordance with Section 2
Paragraph 12 is, assembles medical devices in the sense of § 33 Paragraph 1 or sterilizes them in the sense of § 34, and
has its seat in the area of ​​application of this federal law, taking this into consideration
Provisions of an ordinance according to paragraph 7 to the Federal Ministry of Labor, Health and Social Affairs
or report to a notified body before starting work. This also applies to the rest
Placing medical devices on the market, as far as for them in a regulation according to § 99 distribution channels
are prescribed and enrollment in the register of distributors is planned.
(2) The notification according to paragraph 1 must at least contain:
1. Name or company name and address of the notifier,
2. the type of activity,
3. the type of medical devices,
4. Further information required for the rapid coordination of measures in accordance with sections 75 and 77
are, in particular with regard to the security officer in accordance with § 78 and
5. the business license in accordance with the trade regulations, Federal Law Gazette No. 194/1994.
The notification regarding the first placing on the market is, provided the regulation according to paragraph 7 so provides,
to add more information about the medical devices that are placed on the market for the first time.
(3) Bodies, facilities or persons carrying out testing, monitoring or certi fi cation activities
carry out professionally or commercially according to this federal law, have this before the admission of
Activity at the Federal Ministry of Labor, Health and Social Affairs or a body designated by it
stating the name and address of the body, facility or person and the nature of the
carried out testing, monitoring and certi fi cation activities. Notified bodies in the sense
of Section 2 Paragraph 16 have the Federal Ministry of Labor, Health and Social Affairs or one of these
Notified body particulars related to certificates issued in accordance with the procedures of the Annexes
2 to 5 of Directive 90/385 / EEC, Annexes II to VII of Directive 93/42 / EEC and Annexes III to VII
Directive 98/79 / EC was issued, modified, supplemented, suspended, withdrawn or refused,
tell. The Federal Minister of Labor, Health and Social Affairs has the type, form and content of the
appropriate notifications in line with requirements related to European
To regulate databases for medical devices in a regulation in accordance with Paragraph 7.
(4) Healthcare facilities that operate or use medical devices or for
Have operation or ready for use, which are specified in a regulation in accordance with paragraph 7
this is the Federal Ministry of Health and Consumer Protection or a body designated by it
stating the type of medical devices, the name and address of the facility and data on
to report the availability via telecommunication facilities. When designating the
Medical devices in the regulation according to paragraph 7 is of considerable risk potential
Medical devices and the requirement of prompt information from these facilities in the cases of Section 77
as well as to take into account regulations in accordance with sections 95 and 96.
(5) Subsequent changes to the data in accordance with paragraphs 1 to 4 must be reported immediately.
(6) The Federal Minister of Health and Consumer Protection shall inform the other contracting parties
of the Agreement on the European Economic Area and the European Commission on their
Inquiry as well as by means of a common European data network about the reports according to
paragraphs 1, 2 and 5.
(7) The Federal Minister of Health may consider the consistency of the reports
and on the information required for medical device monitoring by ordinance Art. Content,
Specify the form and procedure of the reports in accordance with paragraphs 1 to 5. With active implantable
Medical devices, for medical devices of classes IIa, IIb and III of directive 93/42 / EEC and for in vitro
Diagnostics in Appendix II and in-vitro diagnostics for self-application of Directive 98/79 / EC can be obtained from
Federal Minister of Health communicating all information that identifies the medical device
enable as well as the labeling and instructions for use if these medical devices
be put into operation within the scope of this federal law. The Federal Minister for
Health can also regulate the reporting obligations, modalities and access authorizations in this regulation
With regard to the European database as defined by Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC
establish.
Section 2
monitoring
Section 68. (1) Companies, facilities or persons who work professionally or commercially with medical devices
bypass, in particular manufacture, test, store, transport, pack, exhibit, in
Bring traffic or put it together within the meaning of Section 33 (1), the medical devices professionally or
professionally maintain, convert, assemble, adapt or process the medical devices professionally
or professionally clean, disinfect or sterilize or medical devices in facilities of the
With regard to these activities, the application or operation of health care is subject to
Monitoring.
(2) Monitoring within the meaning of paragraph 1 is carried out by the organs of the Federal Office for Security in the
Healthcare, the Federal Minister of Health and Women or by commissioned by them
Expert. The activity of relevant accredited bodies, from
Federal Minister of Health and Women recognized organizer of proficiency tests, by operators of
Medical device registries or other organizers from the Federal Minister of Health and Women
recognized cross-regional comparative tests and assessments related to
Medical devices.
(3) Insofar as within the scope of conformity assessment procedures according to a regulation according to § 28
Monitoring is provided, it is carried out by the for the respective conformity assessment procedure
competent notified body. Monitoring by notified bodies is carried out in accordance with a regulation
according to § 28.
(4) The monitoring pursuant to Paragraph 1 can relate to all aspects that affect security,
Functionality and quality of medical devices as well as the protection of health and safety
Can influence patients, users or third parties.
(5) The surveillance of health care facilities can take into account the
The respective hazard potential is carried out systematically, on a sample basis or in the event of an incident, especially in the
With regard to possible threats to the life or health of patients, users or third parties
in connection with medical devices or with a view to ensuring a quality-assured
Provision, application and maintenance of medical devices in the interest of health. Lies a
Violation of provisions of this federal law or on the basis of decrees issued
before, the institution must be instructed to remedy the defects within a reasonable period of time. comes
when surveillance reveals that a violation of the provisions of this federal law or
on the basis of enacted regulations the life and health of patients, users
or third parties is endangered, the necessary measures to protect life and the
Health of these people.
(6) The monitoring of facilities and establishments by establishments, facilities or persons
have been commissioned with the storage and transport of medical devices within the meaning of paragraph 1
only permitted if circumstances exist which justify the assumption that medical devices are stored or
the means of transport are misused as storage facilities via which to process the
Transport agendas may be used beyond the time required.
(7) The organs of the Federal Office for Safety in Health Care, the Federal Ministry for
Health and women and the experts commissioned in accordance with paragraph 2 are authorized to
1. to enter and view real estate, business premises, business premises, means of transport, in
or on which an activity according to paragraph 1 is carried out,
2. Visiting and checking medical devices, especially putting them into operation and
Taking samples
3. to inspect and check any necessary measuring and testing equipment,
4. those based on this federal law or the ordinances issued under this federal law
documents to be kept available
a) Development, manufacturing, testing, clinical testing and evaluation, performance evaluation test
and performance evaluation of in vitro diagnostics, acquisition, storage, packaging, in-circulation
Bringing and other whereabouts of medical devices,
b) the erection, operation, application, preparation and maintenance of medical devices,
c) Precautions and measures for quality management when handling medical devices,
d) measures to ensure the safety of medical devices and to avert risks,
in particular also according to § 72,
e) the information and advertising material on the market,
f) the performance of testing, monitoring and certi fi cation activities in accordance with this
Federal law,
g) the conformity assessment,
h) the fulfillment of the basic requirements within the meaning of sections 8 and 9 and a regulation
according to § 10 and other relevant information for medical device safety
to request, inspect and, in justified cases, make copies or copies thereof and
5. to request all necessary information, in particular about the operations mentioned in item 4.
(8) Companies, facilities and people in accordance with paragraph 1 must tolerate measures in accordance with paragraphs 5 to 7
and the bodies responsible for monitoring the Federal Office for Safety in Health Care, the
Federal Ministry of Health and Women and the experts commissioned in accordance with paragraph 2
to support the fulfillment of their tasks. You are committed to these premises
Medical devices and records to make the prescribed or regulatory
to allow the ordered test, to provide the necessary staff and resources and the
To provide information and to submit the documents necessary for the fulfillment of the tasks of the monitoring
entrusted bodies or the experts commissioned in accordance with paragraph 2 are required.
(9) The official acts in accordance with paragraphs 5 to 8 are, except in the event of imminent danger or if the
there is reasonable reason to believe that the effectiveness of the official act will be impaired during the
Carry out operating times and announce them in advance. The organs and the experts according to paragraph 2
in their surveillance activities must take care that each is not absolutely necessary
Disruption or hindrance to the activities of companies, facilities or persons in accordance with paragraph 1
is avoided.
(10) The Federal Minister of Health and Women has an appropriate perspective
and effective control for the following calendar year a directive on the implementation of the
To issue inspections (inspection plan). The Federal Office for Safety in Health Care has under
Compliance with this guideline and the Federal Ministry of Health and Women by
Report on the execution on March 31 of the following calendar year.
(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 rules for accreditation and
Market surveillance in connection with the marketing of products and the lifting of
Regulation (EEC) № 339/93 for products within the meaning of this federal law is the Federal Office for
Healthcare security.
(12) The Federal Office for Safety in Health Care has in accordance with the requirements of
Federal Ministry of Health to create market surveillance programs for medical devices and
to update and carry out regularly. These are for the Federal Minister of Health
To submit approval. The Federal Office for Safety in Health Care has these programs
to other Member States and the European Commission and to the public by means of
to provide electronic means of communication and, if necessary, by other means.
(13) The Federal Ministry of Health has the functioning of the market surveillance activity of the
Federal Office for Safety in Health Care regularly, but at least every four years
review and evaluate. The results of these reviews are the other Member States and the
To be communicated to the European Commission and by means of electronic means of communication and, if necessary
to make other means available to the public.
Monitoring of testing, monitoring and certification bodies;
Monitoring the notified bodies
Section 69. (1) Surveillance in accordance with Section 68 is also subject to those bodies, institutions or persons who
Carry out testing, monitoring and certification activities in accordance with this federal law.
(2) Insofar as the bodies or institutions in accordance with paragraph 1 are accredited bodies within the meaning of
Accreditation Act is the monitoring by the Federal Minister of Health and
Consumer protection in agreement with the Federal Minister for Economic Affairs in
To be carried out within the framework of Section 13 of the Accreditation Act.
(3) The surveillance in accordance with paragraphs 1 and 2 can deal with all aspects that the
proper execution of testing, monitoring and certi fi cation activities in accordance with this
Federal law and the guarantee of medical device safety. You can in particular
to monitor the existence of the necessary requirements for the implementation of test,
Surveillance and certi fi cation activities under this federal law. Section 68 paras. 3 and 4 and
6 to 9 are used analogously.
Section 3
Reporting requirements, recording and evaluation of reports; investigations
Announcements
§ 70. (1) Relatives of a legally regulated health care profession, business owners, the
professionally authorized to operate or use a medical device, head of relevant
Testing, inspection and certi fi cation bodies and technical safety officers from hospitals
have information about medical devices regarding incidents, in particular
1. Any malfunction or change in the characteristics or performance of a medical device as well
any deficiency in the labeling or in the instructions for use that are suitable for:
Death or serious deterioration in a patient's health,
a user or a third party or who has led to it, or
2. previously unknown serious side effects or the increased occurrence of known ones
serious side effects, or
3. previously unknown mutual influences, or
4. serious quality defects,
which have become known to you on the basis of your professional activity, immediately to the Federal Office of
Healthcare security reporting, as well as all observations and data relevant to that
Medical device safety can be important.
(2) Reports in accordance with Paragraph 1 are in default at hospitals, except where there is any other danger,
to be carried out uniformly by the medical director.
(3) All natural or legal persons who place medical devices on the EEA for the first time
and those companies, facilities or persons who place medical devices on the market have this
Federal Office for Safety in Health Care immediately incidents according to paragraph 1 and above
corrective measures, such as
1. Any technical or medical reason associated with a medical device that
Systematic recall of medical devices of the same type from the market by the manufacturer
has led
2. the issuing of a recommended measure,
3. the additional monitoring or modification of products,
4. Modifications to the product design of components or the manufacturing process, and
5. Modifications to the labeling or the instructions for use
tell.
(4) The Federal Office for Safety in Health Care has to take the necessary measures
thus the person responsible for the first placing on the market in the EEA also of an incident
is taught in accordance with paragraph 1.
(5) To the extent that it ensures the uniformity and the information content of the reports
is required, the Federal Minister of Health and Consumer Protection has considered the
Requirements for in-depth and quick information by regulation, more detailed provisions on content,
Scope, form and transmission of the messages as well as the data carriers to be used and
To establish communication channels.
(6) All natural or legal persons who place medical devices on the EEA for the first time
and those companies, facilities or persons who place medical devices on the market are obliged to
their reporting and information obligations in connection with incidents in accordance with paragraphs 1 and
Measures according to paragraph 3 towards the contracting parties of the EEA in accordance with the guidelines
90/385 / EEC, 93/42 / EEC and 98/79 / EC immediately and verifiably to comply.
(7) After the Federal Office for Safety in Health Care an incident according to paragraph 1 and
Measures in accordance with paragraph 3, if possible together with the manufacturer or his authorized representative,
has assessed the European Commission and the other Member States immediately via the
to teach measures taken. This excludes information about the underlying
Incidents.
Registration and evaluation of reports; investigations
Section 71. The Federal Office for Safety in Health Care has knowledge of it according to Section 70
to record, assess and, if necessary, the information provided under this Act
to determine, coordinate and monitor the measures to be taken. The responsibilities and
Obligations of those responsible for placing on the market as well as professional or professional users
and operators according to § 72 are not affected.
Section 72. (1) The users and operators of medical devices in healthcare facilities
as well as those responsible for placing medical devices on the market, especially in the
Connection with the evaluation of reports according to § 70 or a justified suspicion according to
Section 75, which became known to them in the course of their professional or commercial activity, obliges
1. Take all necessary measures and precautions in your own area to avoid possible risks
and identify risks to the health and safety of patients, users or third parties
and evaluate
2. All necessary precautions and measures, especially with regard to the transfer of
Information about dangers posed by medical devices to protect health and safety
Ensure the safety of patients, users or third parties, and
3. to support investigations by the competent authorities with all available means and
if necessary, to carry out or arrange for own examinations of medical devices
and to make their results immediately available to the competent authorities.
(2) Within the scope of the obligations according to paragraph 1 are in particular also
1. Medical devices and their instructions for use or accompanying information and, insofar as this is for the
Evaluation is important, also combinations with accessories, with other medical devices, with
Make medicinal products or other products accessible for examinations,
2. If applicable, documents and other information, as well as certi fi cates and other information
through the conformity assessment procedures carried out to make an assessment
enable to what extent the medical device and its manufacture meet the requirements of this
Comply with federal law,
3. If necessary, comparisons with similar or similar medical devices from our own
Area to allow
4. Information on the exact identification of the affected medical devices or combinations according to Z 1
to give
5. Submit data regarding the traceability of medical devices according to § 73 and
6. if necessary, all for the clarification and evaluation of the specific conditions of the installation,
Erection, maintenance and application of the affected medical devices necessary information
and to provide information.
Section 72a. (1) Is there a reasonable suspicion that a patient is suffering from a defective medical device?
Has suffered health damage or has been killed, is the establishment of health care
undertakes, in the procedure according to § 72, the legal position of the patient or, if applicable
Survivors with regard to the importance of the medical device for enforcement
Preserve liability claims.
(2) Agreements through which healthcare facilities perform their obligations
hindered in accordance with paragraph 1 are void.
Section 4
Implant register, traceability of medical devices;
observational
Pacemaker, ICD, loop recorder registers
§ 73. (1) Gesundheit Österreich GmbH is entitled to
1. for the purpose of protecting the health and safety of patients, users or third parties and
to ward off risks associated with pacemaker implants,
implantable defibrillators and loop recorders,
2. for the purpose of medical device vigilance and market surveillance related
Pacemakers, implantable defibrillators and loop recorders,
3. for the purpose of quality-assured treatment in connection with the corresponding
implantations
4. for the purpose of quality assurance of pacemakers, implantable defibrillators and loop devices
recorders,
5. for the purpose of statistics as a basis for planning, quality assurance and quality reporting
in Austrian healthcare and
6. for scientific purposes
maintain a register for pacemakers, implantable defibrillators and loop recorders. The
Gesundheit Österreich GmbH is responsible for the register.
(2) The following data categories are processed in the register:
1. Data on the implanting / treating healthcare facility (name of the
implanting / treating institution or name of the treating doctor,
Hospital number, contact details),
2. Data on patient identification (name, gender, date of birth, social security number,
Contact details, area-specific personal identifier),
3. if applicable, death data (date, cause of death, autopsy status),
4. relevant clinical data on medical history, current state of health and indication
(Pre-intervention, symptoms, etiology, preoperative cardiac rhythm),
5. Technical, clinical, organizational and temporal data on the care process (surgeon,
Implantation data of the medical devices and the associated probes, date of implantation,
Localization of medical devices, access, secondary prophylaxis),
6. Technical data on the implant, speci fi c implant parameters, data on the individual
Implant setting (model, manufacturer and serial number of the medical devices and the
associated probes, implant parameters), and
7. Technical, clinical, organizational, time and event-related data for aftercare
(technical and clinical control data of the implanted medical devices and the associated
Probes, functional status, date and indication of the control, complications, explant date,
Explantationsgrund).
(3) The implanting / treating health facilities are in accordance with paragraph 4
obligates the personal data types of Gesundheit Österreich GmbH mentioned in paragraph 2 online
to transmit.
(4) The transmission according to paragraph 3 is only permitted if the data subjects
1. About processing for the purposes of the pacemaker, ICD, or loop recorder register
have been informed and
2. have expressly consented to this processing.
If the consent is withdrawn during a follow-up contact, the person concerned must be informed that
that the data for direct personal reference is irreversibly deleted and the remaining data,
due to a lack of assignability, can no longer be used for their treatment purposes. Does it exist
The person concerned, even after being informed about these consequences by revoking their consent, is the
Gesundheit Österreich GmbH to inform you of the revocation. Gesundheit Österreich GmbH has the
Pseudonymize data immediately.
(4a) If no consent has been given, the implanting or treating
health facilities
1. the data in accordance with paragraph 2 items 1 and 3 to 7 and
2. to transmit the area-specific personal identifier health (bPK-GH).
Data transmitted on the basis of this paragraph may only be processed for the purposes of paragraph 1 numbers 5 and 6
become.
(5) The granting of access rights to the pacemaker, ICD and loop recorder
Register by health care institutions is through Gesundheit Österreich GmbH
documented in a comprehensible manner. When granting access authorizations by institutions of the
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. The granting of access authorization has changed
to refer to specific people, their clear identity and scope of health justification
Österreich GmbH must be proven.
(6) When processing data in accordance with paragraphs 1 and 2, the patient must be used to identify the patient
Name and area-speci fi c personal identifier GH and AS (§ 10 para. 2 E Government
Law, Federal Law Gazette I № 10/2004) is permitted. The area-speci fi c personal identifier AS may only be in
encrypted form can be used and saved. The direct personal reference is from
Delete the responsible person immediately, irreversibly, as soon as he does not do so for the purposes of paragraph 1 nos. 1 and 3
more is needed.
(7) Gesundheit Österreich GmbH is entitled to the Federal Statistical Office Austria
Request information on the time of death and the cause of death of persons whose data are in the
Registers are processed.
(8) The managing director of Gesundheit Österreich GmbH has to ensure that identity and role
the person authorized to access with each access is proven according to the state of the art and
be logged. He must ensure that the appropriate state-of-the-art technology is used
Precautions are taken to prevent the data from being destroyed or changed
Prevent program errors (viruses) in order to destroy, change or query the data of the
Prevent registers by unauthorized users or systems. Furthermore, he must ensure that everyone
processing operations carried out, such as in particular entries, changes, queries and
Submissions that are traceable. He has to create a data security concept for the employees
Health Austria GmbH is binding.
(Note: Paragraphs 9 and 10 repealed by Art. 47 Z 18, Federal Law Gazette I No. 37/2018)
(11) Gesundheit Österreich GmbH may apply to those processed or to be processed in the register
Data
1. basically only in pseudonymized form,
2. to exercise the rights of the persons concerned in accordance with Chapter 3
Basic regulation but also in a directly personal form
access. For scientific purposes, Gesundheit Österreich GmbH may only use a pseudonym
Access form.
(12) The health care institutions participating in the registers may
1. For the purposes of paragraph 1 no. 3, all data relating to this person in the register also in
access personal form if this is part of a specific treatment situation of the
each person is required
a) with the express consent of the data subject, or
b) if it is impossible to obtain consent, in the vital interest of those concerned
Person, and
2. for scientific purposes (para. 1 no. 6) in pseudonymized form to those processed in the register
Access data.
(13) The Federal Office for Safety in Health Care is for the purposes of medical device vigilance
authorized to access the data processed in the register in personal form, provided that this is in the
Individual case to protect the health and safety of patients and to ward off serious risks
necessary is. Otherwise, the Federal Office for Safety in Health Care for the purposes of
Medical device vigilance and market surveillance and for quality assurance purposes
Medical devices are authorized to access the data in the register in an indirectly personal form.
(14) The managing director of Gesundheit Österreich GmbH is obliged to have access authorization for
assign the individual users of Gesundheit Österreich GmbH individually. The authorized users of the
Gesundheit Österreich GmbH are aware of the provisions of the General Data Protection Regulation and that
To teach data security concept. These access rights are deprived of their access rights,
if they no longer need them for the further fulfillment of the tasks assigned to them or they
Do not process data in accordance with its intended purpose.
(15) The managing director of Gesundheit Österreich GmbH has through organizational and technical
Precautions to ensure that access to rooms in which the database server is located
In principle, only those with access to access from Health Austria GmbH are possible.
(16) If the database server is removed from the area of ​​Gesundheit Österreich GmbH, the
Managing Director of Gesundheit Österreich GmbH ensure that unauthorized use
is excluded.
(17) The marketers of medical devices that are used in pacemaker, ICD, loop recorder
Registers are kept, the technical data required for the purposes of the register are required
to provide their implants to Gesundheit Österreich GmbH in electronic form.
(Note: Paragraph 18 repealed by Art. 47 Z 24, Federal Law Gazette I No. 37/2018)
implant register
Section 73a. (1) Gesundheit Österreich GmbH is entitled to
1. for the purpose of protecting the health and safety of patients, users or third parties and
to ward off risks from implantable medical devices,
2. for the purpose of medical device vigilance and market surveillance of implantable
Medical devices,
3. for the purpose of quality assurance of implantable medical devices,
4. for the purpose of statistics as a basis for planning, quality assurance and quality reporting
in Austrian healthcare and
5. for scientific purposes
Implant register for active implantable medical devices, soft tissue implants, cardiovascular,
to carry neurological and orthopedic implants.
(2) The following data categories can be processed in the registers:
1. patient identification (year of birth, gender, area-specific personal identifier),
2. Data about the implanting healthcare facility, in particular for its identification,
3. relevant clinical data on medical history, current state of health and indication,
4. technical, clinical, organizational and temporal data on the care process,
5. Data for the measurement of results (outcome),
6. Technical data on the implant, speci fi c implant parameters, data on the individual
Implant setting, and
7. Technical, clinical, organizational, temporal and event-related data for aftercare.
(3) The implanting / treating institutions of the healthcare system are, if this is the
Protection of the health and safety of patients is required, the obligations mentioned in paragraph 2 and
Personal Austria data required for the purposes of keeping the register
to be submitted online. The granting of access to health care facilities is
clearly documented by Gesundheit Österreich GmbH.
(4) The Federal Minister for Health, Family and Youth has set up implant registers
and to specify the speci fi c data sets for the individual registers by ordinance. In this
Regulation are also the specific processing purposes and the respective processing purpose
to set appropriate access rights.
(5) Personal data must be pseudonymized immediately. When processing data according to
Paragraphs 1 and 2 are for patient identification only the use of the area-speci fi c
Personal identifier GH and AS (Section 10 Paragraph 2 E-Government Act, Federal Law Gazette I № 10/2004) permitted. The
Area-specific personal identifiers AS may only be used and saved in encrypted form
become. The direct personal reference must be irreversibly deleted immediately after conversion.
(6) The area-specific personal identifiers are to be deleted as soon as they are used for the purposes
Paragraph 1 are no longer required. The Federal Statistics Austria has health Austria
GmbH - at their request - personal data on the time of death and the cause of death of
To transmit persons whose data are stored in an implant register in accordance with paragraph 1.
(Note: Paragraph 7 repealed by Art. 47 Z 29, Federal Law Gazette I No. 37/2018)
(8) The managing director of Gesundheit Österreich GmbH has to ensure that the clear
Identity and role of those authorized to access the state of the art for each access
be proven and recorded. He must ensure that the appropriate state of the art
Technically appropriate precautions are taken in order to destroy or change the data
prevent program errors (viruses) and to destroy, change or query the
Prevent data from the registry from unauthorized users or systems. Furthermore, he has to
ensure that all usage processes, such as entries, changes,
Queries and transmissions are traceable. He has to create a data security concept for
the employee of Gesundheit Österreich GmbH is binding.
(9) The healthcare institutions participating in the registers may access data in the
Access registers for scientific purposes in pseudonymized form.
(10) Any access to the data processed or to be processed in the registers by the
Gesundheit Österreich GmbH may only be used for the purposes of paragraph 1.
(11) The Federal Office for Safety in Health Care is entitled to the in the registers
access processed data in pseudonymized form 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 market surveillance is necessary.
(12) The managing director of Gesundheit Österreich GmbH is obliged to have access authorization for
assign the individual users of Gesundheit Österreich GmbH individually. The authorized users of the
Gesundheit Österreich GmbH are aware of the provisions of the General Data Protection Regulation and that
To teach data security concept. These access rights are deprived of their access rights,
if they no longer need them for the further fulfillment of the tasks assigned to them or they
Do not process data in accordance with its intended purpose.
(13) The managing director of Gesundheit Österreich GmbH has through organizational and technical
Precautions to ensure that access to rooms in which the database server is located
In principle, only those with access to access from Health Austria GmbH are possible.
(14) If the database server is removed from the area of ​​Gesundheit Österreich GmbH, the
Managing Director of Gesundheit Österreich GmbH ensure that unauthorized use
is excluded.
(15) The marketers of implants that are kept in registers according to paragraph 1 are
undertakes to provide the technical data of your health implants required for the purposes of the register
Österreich GmbH in electronic form.
Traceability of medical devices
Section 73b. The Federal Minister of Health, Family and Youth, insofar as this is in view of the
Protect the health and safety of patients, users or third parties and avert risks
is required considering types, groups or classes of medical devices with increased
Risk potential through regulation for those responsible for placing medical devices on the market and
Health care institutions for appropriate preventive measures and measures with regard to the
Commit to traceability of medical devices while making determinations about
1. The types, groups or classes of medical devices that depend on the requirements of the
Traceability are captured
2. the product- or product group-specific requirements regarding traceability as well
with regard to the type, content, specificity and availability of the necessary records,
and
3. the way of setting up suitable implant registers in facilities of the
Healthcare and the necessary records.
observational
Section 74. The Federal Minister of Health and Consumer Protection may consider
serious interests of public health and with a view to gaining improved
Knowledge about the benefit / risk assessment of certain types or groups of medical devices,
in particular also about the long-term effects of implantable medical devices that can only be
systematic data collection and evaluation can be obtained, prescribe by regulation,
that relevant data that has been collected in connection with the use of these medical devices and
for the acquisition of these findings are necessary for a central evaluation
are put. The personal reference is part of the central collection and evaluation of such data
by pseudonymization.
Section 5
Protection against risks
Section 75. If there is reasonable suspicion that
1. A medical device also contributes to the health or safety of patients, users or third parties
proper implantation, erection, maintenance or according to its purpose
Use beyond a reasonable level based on medical science
can endanger, or
2. a medical device meets the basic requirements in terms of §§ 8, 9, a regulation
§ 10 or, if applicable, does not meet the requirements of § 11, or
3. a medical device has other defects that pose an unacceptable risk to patients,
Can lead users or third parties, or
4. Defects in the development, manufacture or final inspection of a medical device
have occurred or are occurring that pose an unacceptable risk to patients or users
or lead third parties
the Federal Office for Safety in Health Care has to make the necessary assessments,
Monitor measures in accordance with § 72, carry out or arrange for necessary examinations
or the person or device that places the medical device on the market, uses it, puts it into operation or
operates to arrange for the medical device to be operated by a notified body, another appropriate body
accredited body or to be examined by an expert and give him the reports and results
required. The positions or experts are in agreement with the Federal Office for Security in the
Select healthcare.
Section 76. (1) In the context of the assessment of reports in accordance with Section 70 (1), the assessment
especially to extend to the question
1. what caused the event,
2. whether the medical device was in an improper condition,
3. whether there is no longer any danger after the defect has been remedied, and
4. whether new knowledge has been gained, the other or additional precautions,
especially with regard to similar medical devices.
(2) Cash expenses that the Federal Office for Safety in Health Care in connection with a
Assessments in accordance with Section 75 and Paragraph 1 have to be made by the person responsible for placing on the market
wear, if on the basis of such an assessment a measure in the sense of § 77 due to a lack of
a medical device or its labeling or instructions for use.
Section 77. (1) The Federal Office for Safety in Health Care determines that medical devices
1. Can endanger the health or safety of patients, users or third parties, too
if they are properly installed, commissioned, maintained and their intended purpose
be used accordingly, or
2. the basic requirements within the meaning of §§ 8, 9, a regulation according to § 10 or
if applicable, do not meet the requirements of Section 11, or
2a. the fulfillment of the requirements according to Z 2 is insufficiently demonstrated, or
3. otherwise or with regard to their manufacture, show defects that endanger patients,
Can lead users or third parties
it has to take all appropriate measures to withdraw these products from the market
to ensure that they are placed on the market for the first time as well as further, their commissioning and their operation,
Prohibit, restrict, or comply with certain requirements
addictive or to users, patients and third parties on dangers or appropriate
To take precautions. As far as it is to prevent imminent dangers for
the Federal Office for Safety in Health Care can do this
Take measures without previous procedure or before issuing a decision. About here
however, a written notification must be issued within four weeks.
(2) Relate to measures in accordance with paragraph 1 of medical devices with a CE marking in accordance with this
Federal law, the Federal Minister of Health and Consumer Protection has the
Commission of the European Union and the other contracting parties to the Agreement on the
Inform European Economic Area.
(2a) Medical devices can also be covered by measures in accordance with Paragraph 1, their release
has been suspended by the customs authorities in accordance with Article 27 (3) of Regulation (EC) № 765/2008. The
In this case, the products concerned are in temporary storage in accordance with Article 50 of the Regulation
(EEC) № 2913/92 of the Council of 12 October 1992 establishing the Community Customs Code, OJ.
No.L 302 of October 19, 1992 (Customs Code).
(3) Without prejudice to paragraph 1, the Federal Minister of Health has more detailed provisions on
Preventing harmful effects of types or groups of medical devices or for protection
the patient, user or third party by ordinance if this is for reasons of
Health protection, medical device safety or in the interest of public health
is necessary, and through this the Commission and the other parties to the European Union
To inform the economic area accordingly. The Federal Minister of Health also went through
Accompanying regulations required, in particular to determine
Enforcement powers, with regard to relevant regulations of the European Union.
Section 6
Safety officer for medical devices; Medical device consultant
Safety officer for medical devices
§ 78. (1) Who is responsible for the first placing on the market of medical devices in the
Scope of the European Economic Area is and its seat in the scope of this
Federal law, has a person with the expertise and knowledge necessary to carry out their duties
Order reliability as a safety officer for medical devices.
(2) The safety officer for medical devices has made known reports about risks
Collect and evaluate medical devices and coordinate the necessary measures in accordance with Section 72.
He is responsible for the fulfillment of the reporting obligations insofar as they concern medical device risks, and for cooperation
responsible under the European Medical Device Monitoring System.
(3) The Federal Minister of Health and Consumer Protection, insofar as this is possible with regard to the
Ensuring medical device safety and warding off risks appears necessary through
Ordinance specifies the requirements for safety officers for medical devices
establish.
Medical device consultant
Section 79. (1) Anyone who places medical devices on the market for commercial or professional purposes may only use such persons
commissioned to visit specialist groups within the scope of the professional exercise to inform them about the respective
To provide medical devices with technical information and to handle the medical devices properly
to instruct those who have the necessary medical and medical technology expertise
(Medical device consultant).
(2) The manufacturer or a person or body commissioned by him has the medical device consultants
to train regularly. The manufacturer has submitted to the Federal Office for Safety in Health Care
Request to prove the expertise of his medical device consultants.
(3) A job as a medical device consultant may only be carried out by those who are listed in paragraph 1 and in a
Ordinance pursuant to Paragraph 5 fulfilled.
(4) The medical device consultant has messages from members of the specialist circles about side effects,
mutual influences, malfunctions, technical defects, contraindications, falsifications or
other risks for medical devices must be recorded in writing and sent to the person who
has commissioned, or to transmit its safety officer for medical devices in writing.
(5) The Federal Minister of Health and Consumer Protection, insofar as this is possible with regard to the
correct information for users or their instruction in proper handling is required
appears, taking into account the requirements of certain medical device areas or certain
Levels of trade by regulation more detailed requirements for the expertise of medical device consultants
establish.
V. MAIN PIECE
Section 1
Regulations for the erection, operation, use and maintenance of medical devices in and
outside healthcare facilities
General requirements
Section 80. (1) Healthcare facilities must ensure that
1. Medical devices only according to their intended purpose, according to the regulations of this
Federal law or the regulations issued on the basis thereof, the generally recognized
Established, operated rules of technology as well as occupational safety and accident prevention regulations,
applied and maintained,
2. Medical devices for common use with other medical devices, with accessories, with
Software or with other objects only if this connection in the
Is harmless with regard to medical safety and functionality,
3. Medical devices are only used by people who, due to their training, their
other knowledge or based on their practical experience and, if necessary, one
product- or product group-specific instruction the guarantee for a proper
Provide handling; the instructions for use and the other enclosed
to observe safety-related information of the products involved,
4. before each use of a medical device, the users check the functionality,
Operational safety and the proper condition of the medical device convince, so far
such a review is reasonably expected according to the circumstances of the specific application
can be; this also applies accordingly to those common to the medical device
Application related other medical devices, accessories, software and other items,
5. Only medical devices installed, kept ready, put into operation and used in their area
be, their compliance with the requirements according to this by this federal law
the intended procedure was determined.
(2) The Federal Minister of Health and Consumer Protection has for certain species, groups or
Classes of medical devices by ordinance that go beyond the requirements of paragraph 1
Requirements with regard to the construction, operation, use and maintenance of medical devices
in healthcare facilities to the extent that this is to avert special dangers for
Patients, users or third parties is required and insofar as it is not already based on commercial law
Regulations special requirements are set for this.
Commissioning, application
Section 81. (1) The Federal Minister of Health and Consumer Protection has, provided this with regard to the
safe use of medical devices in healthcare facilities or defense
application or other medical device-related hazards is required, by regulation types,
Designate classes or groups of medical devices for their safe operation and safe
Application special safety precautions are to be taken, and minimum requirements for type and
Specify the scope of these security measures. Provided by such a regulation
Regulations regarding the use of medical devices by traders are provided
the Federal Minister of Health and Consumer Protection in agreement with the Federal Ministry
to deal with economic matters.
(2) The institution or person responsible for the implantation of a medical device has the
Patients who are being implanted with a medical device or, if applicable, their legal representative
To provide information including all for the identification of the implanted medical device
of the accessories as well as the safety for the patient after the implantation
necessary information and instructions on behavior are included, including information about
when the patient see a doctor and what environmental influences he or she does not or only under
Should take appropriate precautions. The relevant information in the
Instructions for use and the other safety information attached to the
implantable medical devices must be observed.
(3) The Federal Minister of Health and Consumer Protection, if this is considered
the protection of health and safety and the rights of patients and with regard to
Uniformity and practicability appear necessary in a regulation according to § 92 more detailed provisions
about art. content, scope, issuance and accessibility of information according to paragraph 2 and other for
Patients of certain personal data related to the use of
Medical devices.
(4) When informing patients about the use of medical devices
to pay attention to the corresponding instructions in the instructions for use.
Information for users
Section 82. Instructions for use and safety-related information attached to the medical device
for medical devices within the meaning of Section 81 (1) are to be kept in such a way that they comply with the
Application people are accessible at all times.
Instruction of the staff
Section 83. (1) Medical devices in accordance with an ordinance pursuant to Section 81 (1) may only be used by persons
applied to the medical device or to a medical device of this type
Consideration of the instructions for use and the attached safety-related information in the
Appropriate handling instructed and also on special application and
medical device-specific dangers have been pointed out. Only persons who are allowed to instruct
who, on the basis of their training, knowledge and practical experience, have been instructed in the
Handling these medical devices are suitable. If necessary, the operator has recurring
To provide training.
(2) Are medical devices in accordance with a regulation pursuant to Section 81 (1) with accessories, software or
The training of the personnel has expanded to other medical devices into device combinations
respective combinations and their special features.
(3) Instructions according to paragraphs 1 and 2 are to be documented.
(4) The manufacturer, his authorized representative or the supplier must ensure that for the briefing
Persons according to paragraph 1, second sentence, are available.
inventory
Section 84. (1) Health care facilities have medical devices that are listed in a regulation
are designated in accordance with section 92 to keep an inventory.
(2) The inventory in the sense of paragraph 1 is to be drawn up in such a way that it is determined immediately
can, if and where, medical devices, which are affected by measures according to § 77, in this
Healthcare facility operated.
Maintenance of medical devices
§ 85. (1) Medical devices are subject to the manufacturer's instructions through inspection, maintenance
and maintenance to be comprehensible and properly maintained in such a way that the
Functionality and safety for patients, users and third parties is guaranteed.
(2) Inspection, maintenance and repair as well as all associated tests may only
People or positions are transferred due to their professional training and through
practical experience gained and their knowledge, especially with regard to
Relevant legislation and standards are able to take the necessary measures
to set and assess as well as to recognize the possible effects and dangers and their activity
to be carried out professionally. You have to carry out and evaluate the exams in their
professional assessment be free of instructions.
(3) Health care facilities have all the necessary precautions for the
to ensure proper maintenance of medical devices.
(4) Provided the corresponding types, groups or classes of medical devices in a regulation
are listed in accordance with Section 92
1. the institution of social insurance and medical and / or accident care for medical devices, the
the insured / cared for by the above-mentioned carriers for treatment in a home
Environment or for your own use or as part of the
Insurance / pension benefits are at least partially reimbursed in costs, and
2. Institutions that have life-saving or other important medical devices in their health
or have it ready for use in a public area,
to take the necessary precautions for their proper maintenance. The Federal Minister
for health and women in determining these medical devices in a regulation pursuant to Section 92
significant risks to patient health and safety and deterioration
the performance of these medical devices that can be expected in the absence of proper maintenance
would be to take care. In the regulation according to § 92 can also special requirements
with regard to the correct preparation and use of these medical devices and with regard to
required training measures.
§ 86. After the repair of medical devices, they must be safe and functional
essential structural and functional characteristics are checked, insofar as they are due to the repair
can be influenced.
Recurring safety-related tests of medical devices
Section 87. Health care facilities must ensure that medical devices that are used in a medical device
Ordinance according to § 92 are regularly listed by a person or position that is suitable for this purpose
be checked.
Section 88. (1) The examinations in accordance with Section 87 must take into account the type of examination
Medical device and the information provided by the manufacturer to a sufficient extent to the
to be able to assess the safety and functional condition of the medical device. Accessories or
Product combinations that can affect the medical device to a significant degree are too
consider.
(2) The Federal Minister of Health and Consumer Protection has in the regulation pursuant to § 92 in
With regard to the safety of patients, users and third parties and the proper condition of
Medical devices denote those types, groups or classes of medical devices that are regular
Checks are to be made and minimum requirements for type, scope, implementation and intervals
of periodic inspections.
Evaluation and documentation of the tests; device file
§ 89. (1) For the regularly tested active medical devices, facilities of the
Health care to maintain a device directory.
(2) The device directory according to paragraph 1 can be combined with the inventory according to § 84 in one
be performed.
(3) Periodic inspections, inspections after repair or after incidents and their
Results must be documented and listed in the device directory. In the device directory are
to keep the intervals of recurring examinations and briefings according to § 83 evident.
Suitability for exams
Section 90. (1) Only persons are allowed to carry out examinations in accordance with Sections 86 to 88
be used, the
1. on the basis of their professional training and practical experience in the examination of
Medical device experience and knowledge, especially with regard to
the relevant provisions and standards on the required expertise,
2. about the necessary measuring and testing equipment,
3. about the required reliability and
4. In particular with regard to the cases of Sections 87 and 88 on the required organizational
Requirements for the planning, execution and evaluation of the exams
dispose of and are able to conduct the examinations in accordance with Sections 86 to 88 in accordance with their type and scope
and to be carried out comprehensibly. Other than the test, monitoring or
Certi fi cation bodies are suitable for the examinations if they are about persons within the meaning of Z 1 to 4
feature.
(2) Relevant as testing or monitoring bodies for products for the relevant
In any case, bodies accredited by the medical device sector are considered to be suitable bodies within the meaning of paragraph 1.
Avoiding hazards
§ 91. If, in the course of measures to maintain a medical device, hazards for
Suitable measures to take to prevent patients, users or third parties from occurring
To avert danger to people.
statutory authorization
Section 92. (1) The Federal Minister of Health and Consumer Protection has to guarantee and
Maintenance of the medical performance of medical devices according to § 2 paragraph 1 or 5 and
to ensure the continuity of their safe use and the prevention of risks in particular
taking into account the type of health care establishment by regulation
Provisions on the construction, operation, use and maintenance of medical devices
or certain types or groups of medical devices, insofar as the electrical safety and the
functions of medical devices covered by the measurement and calibration law, in agreement with
the Federal Minister for Economic Affairs. He has relevant to it
Take harmonized standards into account. If there are no such speci fi c regulations,
he can refer to other suitable national or international standards.
(2) In a regulation in accordance with paragraph 1 in particular more detailed provisions on
1. any additional requirements required under Section 80 (2),
2. Art. Content, scope, execution and accessibility of records and documentation according to
sections 81 to 84 and 89,
3. the instruction of the personnel according to § 83,
4. The requirements for those persons or bodies who take maintenance or maintenance measures
Examinations are authorized in accordance with sections 81 and 86 to 88,
5. Measures for proper maintenance,
6. Types, groups or classes of medical devices that undergo regular checks
are,
7. Types, groups or classes of medical devices that are subject to a maintenance obligation
Section 85 (4) 1 or 2, including any requirements for availability and
Use of these medical devices and required training measures as well
8. Type, scope, implementation and intervals of examinations in accordance with sections 86 to 88
to enact and designate those medical devices for their safe operation or their safe
Special safety precautions must be taken, as well as minimum requirements for their type
and scope.
(3) The umbrella organization of social insurance institutions is before issuing a regulation in accordance with paragraph 1
with regard to medical devices within the meaning of section 85 (4) (1).
Section 2
Cleaning, disinfection and sterilization of medical devices in or for facilities of the
health
§ 93. (1) Cleaning, disinfection and sterilization of medical devices in or for facilities of the
Healthcare systems are without prejudice to Section 34, taking into account the type of medical devices
such devices or device systems and suitable validated procedures to carry out and in
Organize with regard to the type, size and task of the facility so that the success of this
Process is comprehensibly guaranteed and the safety and health of patients and users
or not endangered to third parties.
(2) Cleaning, disinfection and sterilization of medical devices in or for facilities of the
Healthcare in particular have the requirements laid down in a regulation in accordance with § 94
correspond to.
§ 94. The Federal Minister of Health and Consumer Protection, taking into account Art
and size of the healthcare facility and taking into account the relevant
harmonized standards, other relevant international or national standards with regard to the
Ensure the safety and health of patients, users, or third parties is protected
Regulation to adopt special provisions regarding the
1. devices or systems to be used, their properties and their maintenance,
2. tools to be used,
3. method to be used,
4. Measures for validation and routine control,
5. Organization of sterilization and disinfection,
6. Quality management measures,
7. regular inspections and
8. Relevant basic, advanced and further training of the staff.
Section 3
Quality management measures during construction, commissioning, application,
Maintenance, disinfection and sterilization of medical devices in facilities of the
health
§ 95. (1) The Federal Minister of Health and Consumer Protection, as far as this with the
Erection, commissioning, application, maintenance, disinfection and sterilization of medical devices
in healthcare facilities with a view to ensuring and maintaining the
medical services of medical devices with regard to their intended purpose according to § 2 paragraph 1
or 5, the minimization of possible side effects, compliance with the basic requirements that
Ensuring the safety and health of patients, users or third parties or the defense against
Risks and is indicated in terms of the type and scope of the facility by
Regulation Establish minimum requirements for measures and precautions for quality management.
He has to take into account any relevant national and international standards.
(2) Insofar as it is necessary with regard to the objective of paragraph 1, the Federal Minister for
Health and consumer protection by regulation stipulate those requirements and requirements,
among those in health care systems regarding quality management
Erection, application, operation, maintenance, disinfection and sterilization of
Medical devices or certain types or groups of medical devices within the meaning of this
Federal law can be certi fi ed. He has any relevant national and international
Standards.
(3) The Federal Minister of Health and Consumer Protection can with regard to the flawless
Testing, monitoring and certi fi cation of quality management systems with regard to the establishment,
Application, operation, maintenance, disinfection and sterilization of medical devices or
certain types or groups of medical devices in healthcare facilities and for
Ensuring the fulfillment of the requirements according to a regulation according to paragraph 2 requirements and
Specify requirements for those bodies that check quality management systems in accordance with paragraphs 1 and 2,
monitor or certi fi cate. He has any relevant national and international standards
consider.
§ 96. The Federal Minister of Health and Consumer Protection has, if this with regard to
serious public health interests or averting serious risks are required,
by regulation the application or operation of certain types or groups of medical devices
to restrict healthcare facilities whose quality management systems
in this regard demonstrably meet the requirements of an ordinance pursuant to Section 95 (1) or which are stated in
Are certified in accordance with an ordinance pursuant to Section 95 (2).
minimum standards
§ 97. The Federal Minister of Health and Consumer Protection has, if this with regard to
serious public health interests or averting serious risks are required,
regarding certain medical services by regulation minimum standards for the provision
of these services required medical devices.
VI. KEY PIECE
Section 1
Special regulations for the operation
Section 98. (1) The Federal Minister of Health and Women, in agreement with the Federal Minister
for business and work, provided that this is in keeping with proper operation and the
required quality, safety and performance of medical devices as well as the protection of safety and
Health of the patient, the user or third parties is required by special regulation
Provisions for companies or institutions that use medical devices within the scope of this
Establish, put on the market, process or store federal law.
(2) In a regulation in accordance with paragraph 1 with regard to the safety and performance of
Medical devices and the protection of patients, users or third parties, in particular regulations
about
1. production, storage, acquisition and distribution,
2. Precautions for information and advice as well as instruction in the company and in the
Application of medical devices,
3. Personnel requirements,
4. definition of the respective areas of responsibility of the personnel,
5. Condition, size and equipment of the premises,
6. Hygiene requirements,
7. operational precautions and processes in the context of medical device monitoring and defense
of risks,
8. Maintenance of medical devices in healthcare facilities and others
Operators or users,
9. Quality management measures in manufacturing and other handling
Medical devices,
10. other operational arrangements for good sales and service practice and
11. the keeping and storage of evidence of those relevant to medical devices
Operations.
(3) In a regulation pursuant to paragraph 1, provision must also be made for certain establishments to manufacture and
Storage of and trading in medical devices may only commence after obtaining a permit
through the Federal Office for Safety in Health Care. It can be provided
that the permit is only for the trade or wholesale of certain species or groups of
Medical devices is required. In a regulation according to paragraph 1, the requirements for the
Approval insofar as this affects the safety, quality and functionality of the medical devices and the
Safety and health of patients, users or third parties. It is on the
Expertise, reliability and on organizational requirements to guarantee the
To take medical device safety very seriously.
(4) If the Federal Office for Safety in Health Care determines that in companies within the meaning of paragraph 1
the requirements laid down in a regulation in accordance with paragraph 2 are not complied with and from them
a not inconsiderable risk to the health and safety of patients, users or third parties
grows up, the Federal Office for Safety in Health Care can close the business, if not through
other measures that can be found. Performs the violation of a regulation
in accordance with paragraph 2 of the requirements for an immediate health hazard
these measures can also be taken without a previous procedure. However, this is within
to issue a reasoned decision of four weeks.
(5) The regulations in paragraphs 1 to 4 also apply to persons who meet the requirements in paragraph 1
perform the listed activities professionally.
Section 2
Sales, distribution, prescription of medical devices
Section 99. (1) The Federal Minister of Health and Consumer Protection has considered the
Protection of the safety and health of patients, users or third parties, on ensuring the
required quality of medical devices and taking into account the requirements for delivery,
especially with regard to information, instruction, installation or functional testing as well as with regard to
appropriate precautions to avert risks in agreement with the Federal Minister for Economic Affairs
Matters through regulation stipulate that certain types of medical devices only through
certain businesses or pharmacies may be sold or that for the delivery of the
Medical device must be available to a person whose training and practical experience
this regulation is established. The delivery of these medical devices and advice on this is this
Reserved person. In this regulation, the Federal Minister of Health and Consumer Protection
also determine that certain types of medical devices are not self-service, through vending machines
or may be delivered by mail order.
(2) The Federal Minister of Health and Consumer Protection has for medical devices, their
Installation, commissioning, operation, use or use of health professionals or institutions
the health care system is reserved, or their safe and intended use or use
is only guaranteed by health care facilities, by regulation to protect the
Human health and safety stipulate that dispensing these medical devices only to them
Persons or facilities.
§ 100. The Federal Minister of Health and Consumer Protection has by ordinance for
Medical devices that are intended for use or use by laypeople and that
1. Human health, even if used as intended, directly or indirectly
can be at risk if used without medical or dental supervision,
or their application a medical or dental treatment, diagnosis or advice
presupposes, or the
2. Often not used as intended to a considerable extent if this means that
Human health is directly or indirectly endangered,
to stipulate that they may only be given with a prescription.
§ 100a. (1) If a patient requests a prescription (prescription) to be presented in another party to the
To use the Agreement on the European Economic Area, it must contain at least the following:
a) the name and details of the prescribing doctor's professional qualifications and professional seat
or dentist, including his email address and telephone or fax number with international
Prefix,
b) the name and date of birth of the person for whom the medical device is intended,
c) the name and, if applicable, further information on the identity of the person prescribed
Medical device,
(d) the date of issue and
e) the signature or qualified electronic signature of the prescriber.
(2) Also prescriptions in the sense of § 100 are prescriptions that are in other contracting parties of the
Agreement on the European Economic Area by a person authorized to prescribe there
Taking into account the information in paragraph 1 on cross-border use were issued and in
Austria to be submitted for tax.
Section 101. Visiting persons who are neither authorized to sell medical devices, nor in
Health care facilities operate for the purpose of collecting orders from
Medical devices without a medical prescription are prohibited. It is also prohibited
the order to do so.
Section 3
Advertising for medical devices
misleading
Section 102. (1) It is forbidden in connection with the placing of medical devices on the market
To label or put up or to give information about these, the facts
do not match or are misleading.
(2) A misleading situation exists in particular if
1. medical devices are given a performance that they do not have,
2nd wrongly gives the impression that success can be expected with certainty or that
Intended use, no harmful effects will occur or
3. to deceive about the in the basic requirements within the meaning of sections 8, 9 and one
Ordinance according to § 10 defined product properties, suitable names, information or
Presentations are used that are decisive for the evaluation of the medical device.
(3) It is also prohibited to announce or place objects on the market that are of a type or shape
the announcement or the placing on the market are incorrect, the expectation of the user is incorrect
awaken that these objects are themselves medical devices or have one of a medical device
corresponding mechanism of action.
Section 103. Information on the intended purpose in advertising materials may be used for labeling and
Do not contradict the instructions for use and no information regarding an additional purpose
contain.
lay Advertising
Section 104. Advertising intended for consumers may not be used for
1.medical devices that are subject to a prescription requirement according to an ordinance according to § 100,
2. Medical devices that are exclusively intended for healthcare professionals on or for
to be applied to the patient, or
3. Medical devices, their use by consumers based on the instructions for use only in
In connection with medical or dental treatment or surveillance
may,
operate.
Section 105. Medical device advertising intended for consumers must be designed in such a way that the
Advertising character is clearly expressed and the product is clearly represented as a medical device.
Section 106. Medical device advertising intended for consumers may not contain any elements that
1. suggest that the effect corresponds to another treatment or another medical device
or is superior
2. are intended exclusively or mainly for children,
3. Make medical treatment seem superfluous, especially by making it one
mislead self-diagnosis, or treatment by correspondence
recommend,
4. Abusive, worrying or misleading
Get recovery certificates,
5. Abusive, worrying or misleading representations of the
Changes in the human body due to illness, injury or
Disabilities or the effect of a medical device on or in the human body
use.
Section 107. (1) Medical device advertising intended for consumers has at least the following information
to contain:
1. the name of the medical device,
2. the intended use of the medical device,
3. the information essential for the sensible use of the medical device,
4. A clearly perceptible indication if the medical device is also undesirable
May cause effects or its use requires special safety precautions.
(2) Medical device advertising, which is intended for consumers, has a reference to this if applicable
to include that the instructions for use be followed carefully and, if necessary, the advice of a doctor,
Dentists, dentists, pharmacists or any other, due to their professional training
authorized person. If advertising is carried out via acoustic or audiovisual media, this must be done
Notice to be clearly audible acoustically.
professional advertising
Section 108. In the context of sales promotion for medical devices among the persons to whom under the
Prescription, dispensing, procurement for health care facilities, construction, commissioning
or application tasks, it is prohibited to give them a premium, fi nancial or material
To grant, offer or promise benefits unless they are of little value and to those
medical or medical practice of concern. The people who in connection with the
Prescription, dispensing, procurement for health care facilities, construction, commissioning
or application of medical device tasks, it is prohibited to make a premium, fi nancial or
to demand material advantages, to be promised or to accept.
Section 109. Medical device advertising intended for healthcare professionals may be
Package leaflet or other approved in a conformity assessment procedure in accordance with § 28
Don't contradict information.
VII. MAIN PIECE
Section 1
Confidentiality and automated data traffic
Section 110. Unless there are other statutory confidentiality obligations, persons are
who are assigned tasks in connection with the implementation of this federal law, for
Confidentiality about all facts that became known to them exclusively from this activity
Committed.
Section 110a. (1) To ensure the safety of medical devices and to ensure protection
of people's lives and health may be required for the implementation of this federal law
Data (Art. 4 Z 1 General Data Protection Regulation) about the manufacture, the placing on the market, the
Be ready, building, using, testing, clinical evaluation and testing
Performance evaluation and performance evaluation test, preparation, commissioning, the
Quality management, maintenance, market surveillance and vigilance of medical devices
be processed with automation support.
(2) To ensure the safety of medical devices and to ensure the protection of
Life and health of people are allowed for the enforcement of this federal law with regard to
Medical device monitoring requires personal data from patients
as well as subjects in connection with the use of medical devices
be processed with automation support. The processing of this data by the Federal Office for
Healthcare security must be pseudonymized as long as the data is for purposes
medical device monitoring in this form are required.
(3) The Federal Office for Safety in Health Care is authorized to provide data within the meaning of paragraphs 1 and 2
automation supported
1. the Federal Ministry of Health and Women and subordinate authorities for the purposes of
Paragraph 1
2. the Austrian Agency for Health and Food Security, the Advisory Board in accordance with Section 117 (2)
as well as experts, insofar as they are assigned tasks in the execution of this federal law
which correspond to the intended use of paragraphs 1 and 2,
3. the Austrian Federal Institute for Health Care, university institutes and other the
Institutions serving research, insofar as they are in the interest of public health, for tasks
in the sense of the intended use of paragraphs 1 and 2,
4. the Austrian Chamber of Pharmacists, the Austrian Chamber of Physicians and the Medical Chambers in
the federal states, the Austrian Chamber of Dentists, the umbrella organization of the upscale
medical-technical services, the midwifery committee, the social security institutions and the
Umbrella association of social security institutions, insofar as this data is an essential prerequisite for
form the tasks assigned to them by law,
5. the health care facilities insofar as they place medical devices on the market or
apply and the safe use or protection of life or health of
People require it
6. the World Health Organization within the meaning of the purpose stated in paragraphs 1 and 2, and
7. the competent authorities and notified bodies of the Contracting States to the Agreement on the
European Economic Area and the European Commission for tasks in the sense of
Purpose of paragraphs 1 and 2
to transmit.
(4) The Federal Office for Safety in Health Care and the Federal Ministry of Health and
Women or a body designated by the latter are also authorized to collect data within the meaning of Art. 14a of the
Directive 93/42 / EEC on medical devices and Art. 12 of Directive 98/79 / EC on in vitro diagnostic medical devices
in the European database provided there and the necessary information to the responsible
Authorities and notified bodies of the contracting parties to the Agreement on the European
Economic area and the European Commission to ensure uniform application of the
Implementation of directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC.
Section 2
Penalties
Section 111. Who
1. places a medical device on the market contrary to § 6, erects, installs, puts into operation or
applies or places on the market or starts up in contravention of Section 7 (1),
2. a medical device without information corresponding to § 9 for users, consumers or
Patient donates
2a. contravenes Section 11 or a regulation pursuant to Section 11 (3),
3. places a medical device on the market or puts it into operation which, contrary to § 15, does not comply with the CE
Marking is provided,
4. provides a medical device with a CE marking contrary to Sections 15 to 21,
5. does not meet the conditions of section 23 (1) or does not follow measures in accordance with section 23 (2),
6. places a medical device on the market or puts it into operation for which a conformity assessment does not
or was not made in accordance with Section 27 or a regulation in accordance with Section 28,
7. as a manufacturer of a custom-made product or as his authorized representative, according to his obligations
§ 30 does not comply,
8. Issues a medical device for demonstration purposes, without its obligations according to § 31
comply,
9. assembles a medical device within the meaning of section 33 (1) without the declaration provided for it
to keep ready or not to include the information according to § 35,
10. sterilizes a medical device contrary to § 34, does not have the declaration according to § 34 ready or the
Not include notes according to § 35,
11. Medical devices within the meaning of Section 33 (1) or Section 34 contrary to Section 35 (1) with an additional one
CE marking or the declarations according to §§ 33 and 34 not according to § 35 paragraph 2
holds,
12. leads a notified body without fulfilling the minimum criteria of section 37,
13. in the clinical evaluation or performance evaluation or in the clinical examination of a
Medical device contravenes sections 38 to 65 or a regulation in accordance with section 66,
13a. in the performance evaluation test of an in vitro diagnostic medical device according to § 65a or a regulation
violates § 66,
14. does not meet the reporting requirements of Section 67,
15. measures to monitor his obligation to tolerate or to support it
Measures in accordance with section 22 subsection 2 or section 68 subsection 8 or section 69 subsection 3 do not comply,
16. does not comply with the reporting obligation pursuant to Section 70 or the obligation pursuant to Section 72,
17. the provisions and measures in the sense of a regulation according to § 73 not or not accordingly
§ 73 or an ordinance pursuant to § 73,
18. does not provide data in the sense of a regulation pursuant to Section 74,
19. does not comply with an order pursuant to sections 75 and 77,
19a. contravenes an ordinance pursuant to Section 77 (3),
19b. Commission Regulation (EU) № 722/2012 of 8 August 2012 on special
Requirements concern those laid down in Council Directive 90/385 / EEC or 93/42 / EEC
Requirements for active manufactured using tissue of animal origin
contravenes implantable medical devices and medical devices,
20. Contrary to Section 78, does not appoint a security officer or a security officer who
does not comply with Section 78 or a regulation pursuant to Section 78 (3),
21. as a security officer does not meet his obligations under Section 78,
22. Persons instructed to perform activities in accordance with Section 79 (1) without the requirement
fulfill,
23. the activity of a medical device consultant contrary to Section 79 or a regulation pursuant to Section 79 (5)
exerts
24. does not comply with the general requirements of section 80 or a regulation pursuant to section 80 (2),
25. the requirements of section 81 or a regulation pursuant to section 81 (1) for commissioning are not met
Fulfills,
26. Does not instruct or have personnel instructed in accordance with Section 83 and does not instruct them in accordance with
Section 83 (3) documents,
27. Contrary to Section 84, does not keep an inventory or does not keep the inventory accordingly
§ 84 leads,
28. does not meet its maintenance obligations in accordance with Section 85,
29. does not carry out the tests in accordance with sections 86 to 88 or a regulation in accordance with section 92 or for this
Draws in people who do not comply with Section 90 (1),
30. does not meet his documentation obligation in accordance with Section 89,
31. does not take the measures required under § 91,
32. does not meet the requirements of a regulation pursuant to Section 92,
33. cleans, disinfects or disinfects a medical device contrary to § 93 or a regulation according to § 94
sterilized,
34. the precautions and measures for quality management in accordance with an ordinance pursuant to Section 95
Paragraph 1 does not apply
35. uses a medical device contrary to an ordinance according to § 96,
36. as the operator of a health care facility, the minimum equipment according to a
Regulation according to § 97 is not available,
37. an operation contrary to the special regulations for the operation according to a regulation
Section 98 (1) conducts or carries out activities within the meaning of Section 98 (5) without Section 98 (5)
correspond,
38. runs a business without the required approval in accordance with an ordinance pursuant to Section 98 (3),
39. dispenses a medical device contrary to a regulation in accordance with sections 99 or 100,
40. People for the purpose of collecting orders for medical devices within the meaning of Section 101
visits or places the order,
41. Markings or presentations used, information or announcements that make sense
of Section 102 are misleading or suitable to raise false expectations,
42. advertises medical devices contrary to sections 104 to 107, section 108 or section 109,
43. grants, offers or promises a premium, financial or material advantages contrary to Section 108,
44. in breach of Section 108, requests a premium, fi nancial or material benefits, promises himself or
assumes
45. contrary to § 112 places medical devices on the market, puts them into operation or in institutions of the
Operates or applies health care,
is guilty of an administrative offense if the act is not threatened with judicial punishment and
is to be punished with a fine of up to € 25,000, in the event of repetition up to € 50,000.
Section 111a. The applies to all personal names used in this federal law
chosen form for both genders.
Section 3
costs
Section 111b. (1) The Federal Minister of Health and Women, in agreement with the
Federal Minister of Finance Fees for those to be carried out under this Federal Act
Official acts and activities of federal agencies, the necessity of which derives from this
Federal law and the regulations or relevant legal acts of the
European Union results, set in one tariff. Fees for reports can also be included in the tariff
Section 67 and for reports in connection with implant registers in accordance with an ordinance pursuant to Section 73
be determined.
(2) When determining the chargeable facts, on the one hand, experience has shown that in the
Average costs incurred, on the other hand on the importance or the benefit for the
To take due account of fee debtors. The tariff and its changes are in the “Official Journal
to the Wiener Zeitung ”.
(3) Is the result of this federal law, the regulations issued on the basis thereof
or legal acts of the European Union the need for official acts or activities of
Federal agencies for which a tariff has not been set are the actual costs incurred
prescribe.
(4) For cash expenses, the party, regardless of the fees set in the tariff in accordance with § 76 of the
General Administrative Procedure Act 1991, Federal Law Gazette No. 51.
Section 4
Final and transitional provisions
§ 112. (1) Medical devices within the meaning of Directive 93/42 / EEC, which are physically available as individual
Products conforming to the regulations in force on December 31, 1994 before June 15
Were placed on the market in Austria in 1998, and
1. which are safe and efficient,
2. whose expiry date has not passed and
3. which do not have to be installed or assembled by the end user,
may still be put into operation during a transition period until June 30, 2001, unless
the requirements according to § 8 are not fulfilled or measures according to § 77 are taken.
(2) Medical devices for in vitro diagnosis, which are valid in Austria on December 7, 1998
existing regulations, may continue until December 6, 2003 in Austria
To be placed on the market. In vitro diagnostic medical devices placed on the market in this way may be used until the end of the
Placed on the market or put into service in Austria on 6 December 2005, unless
the requirements according to §§ 8, 9 and 11 are not met or measures according to § 77 are taken.
There are changes to these regulations for the purpose of protecting human beings from one
apply direct or indirect health hazards.
(3) The Federal Minister of Health and Consumer Protection has, provided this with regard to the
Protect the health and safety of patients, users or third parties and protect them significantly
Risks is required through regulation conformity assessment procedures for medical devices for which the
Transitional regulation of paragraph 1 applies as a prerequisite for placing on the market and commissioning
to prescribe and specify their type. Content and implementation.
(4) Clinical trials that started before this Federal Act came into force may continue
the regulations in force at the start of the clinical trial.
(4a) Performance appraisal examinations that started before June 7, 2000 may be conducted according to the
regulations in force at the time the performance assessment test begins.
(5) Mercury glass thermometer with maximum device, for which an EEC type approval in accordance
in implementation of Directive 75/764 / EEC, OJ. № L 262 of July 27, 1976, issued national
Regulations issued until December 31, 1994 may be placed on the market until June 30, 2004 and
be put into operation.
(6) Medical devices that were installed in facilities of the
Healthcare systems in operation or kept ready for use may continue to be operated there
or applied, unless they are defective in terms of their safety or performance,
which can endanger patients, users or third parties.
(7) Companies, facilities or persons within the meaning of Section 67 (1), (3) and (4) which are already in force
of this federal law, they are obliged to notify according to § 67 by
March 1, 1997.
(8) reviews by ethics committees as of the date of entry into force of this
Federal law are pending, are to be up to date by the ethics committees in their composition
End to lead.
(9) Medical devices with derivatives from human blood, which the on January 10, 2002 in Austria in
Applicable regulations, may continue until the end of January 10, 2007 in
Austria are placed on the market. Medical products with derivatives placed on the market in this way
human blood may still be placed on the market in Austria until the end of January 10, 2009
or be put into operation, unless the requirements according to §§ 8 and 9 are not met or
measures are taken in accordance with § 77. Changes to these regulations are for the purpose
the protection of people from direct or indirect health risks
apply.
§ 113. Insofar as this federal law refers to provisions of other federal laws, these are
Applicable provisions in their currently applicable version.
Come into effect
§ 114. (1) This federal law occurs one month after its announcement
First of the month in force.
(2) Section 54 in the version of the Federal Law BGBl. I No. 30/1998 comes into force on January 1, 1998.
(3) Section 2 (5) 1 lit. c to g, § 2 paragraphs 5a and 5b, § 2 paragraph 6, § 2 paragraph 8a, § 2 paragraph 10 line 1, § 2 paragraph 11,
Section 2 (15), the heading to Section 3, Section 3 (2a), Section 3 (3a), Section 3 (7a), Section 3 (14a), Section 9 (2) and (3), Section 9
Section 5, Section 11 Section 4, Section 13 Section 1a, Section 15 Section 1, Section 18 Section 1, Section 19 Section 1, Section 21, Section 27, Section 28 Section 2 Nos 7 to 9, § 29
Paragraph 2, Section 29 Paragraph 5, Section 29 Paragraph 7, Section 31, Section 33, Section 34, Section 37 Paragraphs 9 to 11, Section 65a, Section 66, Section 111 Z 2a, Section 111 Z 13a,
Section 112 (4a) of this Federal Act, in the version of the Federal Law BGBl. I № 117/1999, also come into play
June 7, 2000 in force.
(4) Section 2 (2), Section 2 (13), Section 4 (1) 3 to 5, Section 5 (3), Section 12, Section 14, Section 18 (1), Section 23 (2), Section 24, § 67
Paragraphs 1 to 3, Section 76 Paragraph 2, Section 77 Paragraph 3, Section 111 Z 19a, Section 112 Paragraphs 1 and 2, Section 113, Section 116a, Section 117 Paragraph 1 Section 2
this federal law in the version of the federal law BGBl. I № 117/1999 come into force on December 7th
1999 in force.
(5) § 104 and § 111a in the version of the Federal Law BGBl. I № 33/2002 follow one month
the first of the month following the announcement of the Federal Law BGBl. I No. 33/2002.
(6) Section 5 (3) and Section 29 in the version of the Federal Law BGBl. I № 119/2003 come into force with
Entry into force of an ordinance pursuant to Section 28 (1).
(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
Paragraphs 1 and 2, Section 41 Paragraph 5, Section 44, Section 55 Paragraph 4, Section 56 Paragraph 3, Section 58 Paragraph 3, Section 67 Paragraph 1, 3 and 4, Section 68 Paragraph 2, 7 , 8th
and 10, section 70 subsection 1, 3 and 4, section 71, section 75, section 76 subsection 2, section 77 subsection 1, section 79 subsection 2, section 98 subsection 3 and 4 and section 110a
Paragraphs 3 and 4 in the version of Federal Law BGBl. I No. 107/2005 come into force on January 1, 2006.
(8) At the end of December 31, 2005, pending proceedings according to those listed in paragraph 7
Provisions are to be continued by the Federal Office for Safety in Health Care. The
Administrative files are immediately from the Federal Ministry of Health and Women to the Federal Office
for security in healthcare.
(9) The introductory words of Section 2, Paragraph 1, Section 2, Paragraphs 1a to 1c, Section 2, Paragraph 5c, Section 2, Paragraphs 7, 8 and 8a, Section 3, Paragraph 2,
2a, 2b, 4, 5, 8, 9 and 15, § 4 Abs. 1 Z 1, 4 and 6, § 4a, §§ 5a and 5b including headings, § 8 Abs. 4 and 5, the
Introductory words of section 15 subsection 2, section 22 subsections 2 and 3, section 23, sections 26a and 26b including the heading, section 28 subsection 2 no.4,
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 and 40b including headings, § 41 paragraph 1, 2, 4 and 6,
Section 42 (8), Section 43, Section 44, Section 47 (1), (2) and (3), Section 49, Section 50 (1), 2 and 4, Section 51, Section 52a (3), Section 56 (3) to 7,
Section 59 (1), 1a and 3, Section 60 (1) to (3), Section 61, Section 63 (4) to (6), Section 64 (1), 4 and 7, Section 65, Section 65a (1) and
2, section 66, section 67 (7), section 70 (1), (3), (4), (6) and (7), section 77 (1) lines 2a and 3, section 77 (2a), section 111 (5), 13 and 15,
§ 113, § 116 paragraphs 2 and 3, § 116a No. 7, in the version of the Federal Law BGBl. I № 143/2009 come into play
March 21, 2010 in force. Section 68 (11) to (13) in the version of the Federal Law Gazette I No. 143/2009 also comes into effect
Effective January 1, 2010.
(10) Data protection consent in connection with clinical trials that were carried out before
May 25, 2018, do not need to be renewed.
(11) Sections 11 (4), 49 (4), 5 and 6, 50 (1), 52a (3) and 5, 55 (1), 59 (3), 64
Paragraph 4a, § 73 Paragraph 1, 2, 4, 4a, 5, 6, 8, 11, 12 14, 17, § 73a Paragraph 2, 3, 5, 6, 9, 11 and 12, § 74, Section 89 paras. 1 to 3,
Section 110a (1) to (3) and the deletion of Section 73 (9), (10) and (18) and Section 73a (7) in the version of the
2.Materials Data Protection Adjustment Act, Federal Law Gazette I No. 37/2018, enter into force on May 25, 2018.
(12) Section 50 subsections 2 and 4 and section 52 of this Federal Act in the version of Federal Law Gazette I No. 59/2018 also come into play
July 1, 2018 in force.
Section 115. Ordinances based on this federal law can already be made available from the date of its publication
the following day. They may enter into force at the earliest with the entry into force of this federal law
be set.
§ 116. (1) With the entry into force of this Federal Act, the Health Protection Act, BGBl.
No. 163/1952, no longer applicable.
(2) The ordinance regarding dental amalgam, BGBl. № 575/1990, comes into effect at the end of the day of
Announcement of this federal law in the version of the federal law BGBl. I № 143/2009 except
Force.
(3) The Condom Testing Ordinance, Federal Law Gazette № 630/1990, comes into effect at the end of the day of the announcement
of this federal law in the version of the federal law BGBl. I No. 143/2009.
Reference to guidelines
§ 116a. This federal law makes the following guidelines of the European Community
implemented:
1. Directive 90/385 / EEC relating to active implantable medical devices (OJ № L 189,
July 20, 1990);
2. Directive 93/68 / EEC (OJ No L 220 of 30 August 1993);
3. Directive 93/42 / EEC on medical devices (OJ No. L 169 of 12 July 1993);
4. Directive 98/79 / EC on in vitro diagnostic medical devices (OJ No L 331 of 7 December 1998);
5. Directive 2000/70 / EC (OJ No L 313 of 13 December 2000);
6. Directive 2001/104 / EC (OJ No L 6, 10 January 2002);
7. Directive 2007/47 / EC (OJ No L 247 of 5 September 2007);
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 healthcare (OJ № L 88
from April 4, 2011 p. 45);
9. Commission Implementing Directive 2012/52 / EU of 20 December 2012 with measures to
Facilitate the recognition of medical certificates issued in another Member State
Prescriptions (OJ No L 356, 22.12.2012 p. 68).
completion
§ 117. (1) With the enforcement of this federal law
1. the Federal Minister of Health and Consumer Protection,
2. with regard to § 10 and § 11 paragraph 3 under the conditions of § 12 of the Federal Minister for
Work, health and social issues in agreement with the Federal Minister for Economic Affairs
Affairs,
3. with regard to Section 80 (2), Section 81 (1) and Section 92, insofar as the electrotechnical safety stipulated by
Measurement and calibration law covers measurement functions of medical devices and commercial law
Provisions are concerned, and with regard to § 99 paragraph 1, as far as commercial law concerns
are concerned, the Federal Minister of Health and Consumer Protection in agreement with the
Federal Minister for Economic Affairs and
4. with regard to Section 98 (1) of the Federal Minister of Health and Consumer Protection in
Agreement with the Federal Minister for Economic Affairs
entrusted.
(2) Before enacting ordinances in accordance with this federal law, those responsible pursuant to para
Federal Minister to hear an advisory council, which, in addition to experts in the field of regulation
In any case, a representative of the Federal Ministry of Economics and Labor, the
Federal Ministry of Social Affairs and Consumer Protection, the Austrian Medical Association, the
Austrian Chamber of Dentists, the Federal Chamber of Labor, the Austrian Chamber of Commerce, the
Austrian Chamber of Pharmacists, the main association of Austrian social security institutions, the
Austrian Agency for Health and Nutritional Security GmbH, business unit PharmMed, and
belong to the Austrian Seniors' Council. Furthermore, they are according to the state law
Implementing provisions for § 11e of the Federal Act on Hospitals and Health Centers (KAKuG)
existing patient representative bodies are entitled to send a representative.
(3) The advisory board according to paragraph 2 is chaired by an employee of the Federal Ministry of Health,
Family and youth, the work of the Advisory Board is carried out by the Federal Minister of Health, Family
and youth led to rules of procedure to be adopted. In any case, it should be provided in this case
the advisory board may be referred to in a circular manner with particular urgency or less importance.
In agreement with the chairman, the representatives can call in further experts in accordance with paragraph 2.