Law on Medical Devices (Medical Devices Act-MPG)

Unofficial table of contents

MPG

Date of completion: 02.08.1994

Full quote:

" Medical Devices Act, as amended by the Notice of 7 August 2002 (BGBl. 3146), as set out in Article 278 of the Regulation of 31 August 2015 (BGBl I). I p. 1474).

Status:	New by Bek. v. 7.8.2002 I 3146;
	Last amended by Art. 16 G v. 21.7.2014 I 1133
Note:	Amendment by Art. 278 V v. 31.8.2015 I 1474 (No 35) not yet taken into account

For more details, please refer to the menu under Notes
This law serves to implement

-

Council Directive 90 /385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 327, 30.4.1990, p. EC No 17), as last amended by Directive 93 /68/EEC (OJ L 197, 21.7.1993, p. EC No L 220 p. 1),

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Council Directive 93 /42/EEC of 14 June 1993 on medical devices (OJ L 378, 31.12.1993, p. EC No 1), as last amended by Directive 2001 /104/EC (OJ L 327, 22.10.2001, p. EC No L 6 p. 50) and

-

of Directive 98 /79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 327, 28.12.1998, p. EC No L 331 p. 1).

Footnote

(+ + + Text evidence from: 10.8.1994 + + +) 
(+ + + Official notes of the norm provider on EC law: 
 Implementation of the 
 EWGRL 385/90 (CELEX Nr: 31990L0385) 
 EWGRL 42/93 (CELEX Nr: 31993L0042) 
 EEC-GRL 68/93 (CELEX Nr: 31993L0068) 
 Implementation of the 
 ERL 79/98 (CELEX Nr: 31998L0079) 
 EWGRL 385/90 (CELEX Nr: 31990L0385) 
 EEC-GRL 42/93 (CELEX Nr: 31993L0042)  Bek.  v. 7.8.2002 I 3146 
 Implementation of the 
 ERL 47/2007 (CELEX Nr: 32007L0047)  G v. 29.7.2009 I 2326 
 Implementation of the 
 EGV 765/2008 (CELEX Nr: 32008R0765)  G v. 29.7.2009 I 2326 + + +) 

  

Unofficial table of contents

Content Summary

First section

Purpose, scope of application of the law, definitions

§ 1	Purpose of the law
§ 2	Scope of the law
§ 3	Definitions

Second section

Requirements for medical devices and their operation

§ 4	Prohibitions on the protection of patients, users and third parties
§ 5	Responsible for the initial placing on the market
§ 6	Conditions for placing on the market and putting into service
§ 7	Basic requirements
§ 8	Harmonized standards, common technical specifications
§ 9	CE marking
§ 10	Conditions for the initial placing on the market and the putting into service of systems and treatment units as well as for the sterilisation of medical devices
§ 11	Special rules for placing on the market and putting into service
§ 12	Special products, medical devices made from in-house manufacture, medical devices for clinical testing or for performance evaluation purposes, outlining
§ 13	Classification of medical devices, delimitation to other products
§ 14	Construction, operation, application and maintenance of medical devices

Third Section

Notified bodies and certificates

§ 15	Designation and monitoring of bodies, recognition and appointment of testing laboratories
Section 15a	Designation and monitoring of conformity assessment bodies for third countries
§ 16	Erasing, withdrawal, revocation and revocation of the appointment
§ 17	Period of validity of certificates from the notified bodies
§ 18	Limitation, suspension and withdrawal of certificates, teaching obligations

Fourth Section

Clinical evaluation, performance assessment, clinical trial, performance review

§ 19	Clinical evaluation, performance assessment
§ 20	General requirements for clinical examination
Section 21	Special requirements for clinical testing
Section 22	Procedure at the Ethics Committee
Section 22a	Approval procedure with the Federal Authority
§ 22b	Withdrawal, revocation and revocation of the authorisation or the assessment to be agreed
Section 22c	Changes after approval of clinical trials
Section 23	Conduct of clinical trials
Section 23a	Notifications of termination or termination of clinical trials
§ 23b	Exceptions to clinical trial
§ 24	Performance Assessment Review

Fifth Section

Monitoring and protection against risks

Section 25	General notification requirement
Section 26	Implementation of monitoring
§ 27	Procedure for the unlawful and inadmissible affixing of the CE marking
§ 28	Protection against risks
§ 29	Medical products-Observation and reporting system
§ 30	Medical device security officer
Section 31	Medical Product Advisor

Sixth Section

Competent authorities, legal regulations, other provisions

Section 32	Tasks and responsibilities of the federal authorities in the medical device sector
§ 33	Database-based information system, European database
Section 34	Export
§ 35	Fees and expenses
§ 36	Cooperation between the authorities and the notified bodies in the European Economic Area and the European Commission
Section 37	Regulation
Section 37a	General administrative provisions

Seventh Section

Special provisions for the area of the Bundeswehr

§ 38	Application and enforcement of the law
§ 39	Exceptions

Eighth section

Criminal and penal rules

§ 40	Criminal provisions
Section 41	Criminal provisions
§ 42	Fines
Section 43	Recovery

Ninth Section

Transitional provisions

Section 44

Transitional provisions

First section
Purpose, scope of application of the law, definitions

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§ 1 Purpose of the Law

The purpose of this law is to regulate the traffic with medical devices and thereby to ensure the safety, suitability and performance of medical devices as well as the health and the necessary protection of patients, users and third parties. Unofficial table of contents

§ 2 Scope of the Act

(1) This Act applies to medical devices and their accessories. Accessories are treated as an independent medical device. (2) This law also applies to the application, operation and maintenance of products not placed on the market as medical devices, but with the purpose of determining a product. Medical products within the meaning of Appendixes 1 and 2 of the Medical Devices Operating Regulation are used. They are considered to be medical devices within the meaning of this Act. (3) This Act also applies to products intended to administer medicinal products within the meaning of Section 2 (1) of the Medicines Act. Where the medical devices referred to in the first sentence are placed on the market in such a way that the medical device and the medicinal product form a single product which is connected to each other and which is intended exclusively for use in this connection and which cannot be re-used , this Act shall apply only in so far as the medical device has to comply with the basic requirements laid down in § 7 concerning safety and performance-related product functions. In addition, the provisions of the Medicines Act apply. (4) The provisions of the Atomic Energy Act, the Radiation Protection Ordinance, the X-ray Ordinance and the Radiation Protection Act, the Chemicals Act, the Ordinance on Hazardous Substances, the German Chemical Safety Act, the German Chemical Society, the German Chemical This law shall also apply to products used by the manufacturer for use in the field of safety and security. (4a) This law shall also apply to products which are used by the manufacturer for use in the use of the in accordance with the rules on personal protective equipment Council Directive 89 /686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 376, 27.12.1989, p. 18) and Council Directive 93 /42/EEC of 14 June 1993 on medical devices (OJ L 378, 30.12.1993, p. 1). (5) This Act does not apply to:

1.

Medicinal products within the meaning of Section 2 of the Medicinal Products Act; the decision as to whether a product is a medicinal product or a medical device shall be taken, in particular, taking into account the main mode of action of the product, unless: is a medicinal product within the meaning of Section 2 (1) (2) (b) of the Medicines Act,

2.

cosmetic products within the meaning of Article 2 (5) of the Food, Commodities And Feed Codes;

3.

human blood, human blood products, human plasma or blood cells of human origin, or products containing, at the time of placing on the market, blood products, plasma or cells of this type, in so far as they are not concerned, Medical devices according to § 3 (3) or § 3 (4)

4.

transplants or tissues or cells of human origin and products containing tissues or cells of human origin, or obtained from such tissues or cells, in so far as these are not medical devices in accordance with Section 3 (4),

5.

transplants or tissues or cells of animal origin, unless a product is produced using killed animal tissues or killed products obtained from animal tissues, or it is a product of Medical devices according to § 3 No. 4.

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§ 3 Definitions

1.

Medical devices are all instruments, apparatus, devices, software, substances and preparations used individually or in connection with each other, of substances or other objects, including those used by the manufacturer specifically for the purposes of: diagnostic or therapeutic purposes and the software used for the proper functioning of the medicinal product, the software used by the manufacturer for use by means of its functions for the purpose of:

a)

the detection, prevention, monitoring, treatment or alleviation of diseases,

b)

the detection, monitoring, treatment, alleviation or compensation of injuries or disabilities,

c)

the examination, replacement or alteration of the anatomical structure or of a physiological process, or

d)

of the contraception

, and whose main intended effect in or on the human body is not achieved either by pharmacologically or immunologically active agents or by metabolism, but whose mode of action is supported by such means can be.

2.

Medical devices are also products referred to in paragraph 1, which contain a substance or a preparation of substances or are applied to the substances which, if used separately, are regarded as medicinal products within the meaning of Article 2 (1) of the German Medicines Act (Medicinal Products Act) , and which, in addition to the functions of the product, can have an effect on the human body.

3.

Medical devices are also products as referred to in paragraph 1, which contain, as a constituent, a substance which is used separately as part of a medicinal product or medicinal product derived from human blood or human plasma within the meaning of Article 1 of the Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 327, 22.12.2001, p. 67), as last amended by Regulation (EC) No 1394/2007 (OJ L 311, 28.11.2007, p. 121), which can be regarded as having an effect on the human body, in addition to the product, is to be considered.

4.

In-vitro diagnostic medical device is a medical device which, as a reagent, reagent product, calibration material, control material, kit, instrument, apparatus, apparatus or system, is used individually or in combination with each other in accordance with the intended purpose defined by the manufacturer. In vitro study of samples originating from the human body, including blood and tissue donations, is intended and used exclusively or mainly to provide information

a)

about physiological or pathological conditions, or

b)

about innate anomalies or

c)

to check for safety or tolerability in the case of potential recipients or

d)

to monitor therapeutic measures.

Sample containers are considered to be in vitro diagnostic medical devices. Sample containers shall be air-filled or other medical devices specially manufactured by their manufacturer to record samples originating from the human body immediately after they have been removed, and with a view to: To store in vitro studies. Products intended for general laboratory use shall not be considered as in vitro diagnostic devices unless they are to be used specifically for in vitro studies, based on their characteristics, in accordance with the intended purpose defined by the manufacturer.

5.

In vitro diagnostic agent for self-use is an in vitro diagnostic agent which can be used in the home environment according to the intended purpose of laypersons established by the manufacturer.

6.

New in the sense of this law is an in vitro diagnostic agent, if

a)

such a medical device for the corresponding analyte or other parameter was not available continuously during the preceding three years within the European Economic Area, or

b)

the procedure is carried out using an analysis technique which has not been used continuously within the European Economic Area during the previous three years in conjunction with a particular analyte or other parameter.

7.

The calibration and control materials used shall be substances, materials and articles intended by their manufacturer for the purpose of comparing measurement data or for testing the performance characteristics of an in vitro diagnostic agent with regard to the intended use. Certified international reference materials and materials used for external quality evaluation programs are not in-vitro diagnostics within the meaning of this law.

8.

Special production is a medical device which, according to the written regulation, is specially made according to specific design characteristics and is intended for exclusive use in a named patient. The mass-produced medical device, which must be adapted to meet the specific requirements of the physician, dentist or other professional user, shall not be considered to be a custom-made product.

9.

Accessories for medical devices shall be articles, substances and preparations of substances which are themselves not medical devices referred to in point 1 but are intended by the manufacturer to be used with a medical device in order to ensure that the medical device is used in accordance with the it can be used for the purpose of the medical device. Invasive medicinal products intended for the collection of samples from the human body for in vitro examination, as well as medical devices that come into direct contact with the human body for the purpose of sampling, shall not be considered as accessories. for in vitro diagnostic medical devices.

10.

The use for which the medical device is intended to be used in the labelling, in the instructions for use or on the advertising materials in accordance with the information provided by the group of persons referred to in point 15 is used.

11.

The placing on the market of medical devices shall be subject to any supply of medical devices, whether paid or free. First placing on the market is the first delivery of new or newly prepared medical devices to others in the European Economic Area. The placing on the market under this Act shall not apply

a)

the delivery of medical devices for the purpose of clinical trial;

b)

the submission of in-vitro diagnostics for performance assessment tests,

c)

the re-delivery of a medical device after its entry into service to others, unless it has been reprocessed or substantially changed.

A levy on others is not available if medical devices are prepared for another and returned to the other.

12.

Putting into service is the time when the medical device has been made available to the end user as a product which can be used for the first time in accordance with its intended purpose in the European Economic Area. In the case of active implantable medical devices, the delivery to the medical personnel for implantation is deemed to be put into operation.

13.

The presentation or presentation of medical devices for the purpose of advertising is to be provided.

14.

The preparation of medicinal products intended for use in accordance with the conditions of germarm or sterile shall be the cleaning, disinfection and sterilisation, including the cleaning, disinfection and sterilisation carried out after they have been put into operation for the purposes of re-application. and the testing and restoration of technical-functional safety.

15.

The manufacturer shall be the natural or legal person responsible for the design, manufacture, packaging and labelling of a medical device with a view to the first placing on the market on its own behalf, whether or not Activities carried out by this person or by a third person on behalf of the person. The obligations imposed on the manufacturer under this Act shall also apply to the natural or legal person who assembles, unpacks, treats, processes, characterizes or defines one or more pre-fabricated medical devices the intended use as a medical device is responsible for the first placing on the market in its own name. This shall not apply to natural or legal persons who-without being a producer within the meaning of sentence 1-assemble medical devices already placed on the market for a named patient in accordance with their intended purpose, or .

16.

The authorised representative shall be the natural or legal person established in the European Economic Area, which has been expressly designated by the manufacturer to act on his behalf in respect of his obligations under this Act and to act on his behalf. authorities and competent authorities.

17.

Professional circles are members of the medical profession, the medical profession, or the health-care facilities, and other persons, as far as they manufacture medical devices, inspect, place on the market in the exercise of their profession, implant, in Take, operate, operate or use.

18.

Harmonized standards are such standards by States Parties to the Agreement on the European Economic Area, which comply with the standards whose references are published as a "harmonised standard" for medical devices in the Official Journal of the European Union. . The findings of the relevant standards are published by the Federal Institute for Drugs and Medical Devices in the Federal Gazette (Bundesanzeiger). The standards referred to in sentences 1 and 2 are monographs of the European Pharmacopoeia relating to medical devices, the references of which are published in the Official Journal of the European Union and are published as monographs of the European Pharmacopoeia, the Official Journal of the European Communities, German edition, published in the German Federal Gazette, equated.

19.

Common technical specifications shall be those specifications, the in vitro diagnostic devices referred to in Annex II, Lists A and B, of Directive 98 /79/EC of the European Parliament and of the Council of 27 June 1999, of the European Parliament and of the Council of the European Communities, October 1998 on in vitro diagnostic medical devices (OJ L 327, 28.12.1998, p. EC No 1), as amended, and whose references have been published in the Official Journal of the European Union and published in the Federal Gazette (Bundesanzeiger). These specifications shall specify criteria for the evaluation and re-evaluation of the performance, batch release criteria, reference methods and reference materials.

20.

The notified body shall be a body designated for carrying out tests and issuing certificates in connection with conformity assessment procedures in accordance with the provisions of Article 37 (1) of the Regulation, as provided for by the European Commission and , the Contracting State of the Agreement on the European Economic Area has been designated by a State Party to the Agreement on the European Economic Area.

21.

Medical products derived from their own production are medical devices, including accessories which are manufactured and used in a healthcare facility without being placed on the market or subject to the conditions of a special manufacturing process, Number 8.

22.

In vitro diagnostic medical diagnostics are in-vitro diagnostic medical devices manufactured in laboratories of health facilities and used in these laboratories or in rooms in close proximity to them, without the need for them to be used in the Transport is brought. For in vitro diagnostic devices manufactured on an industrial scale, the rules on self-production are not applicable. Sentences 1 and 2 shall apply mutaly to in vitro diagnostic medical devices manufactured in blood establishments which are used for the examination of blood preparations, provided that they are authorised in the context of the marketing authorisation of the competent authorities of the competent authorities of the competent authorities of the Member States of the European Union. are subject to federal authority.

23.

Sponsor is a natural or legal person who assumes responsibility for the instigation, organization and financing of a clinical trial in humans or a performance assessment test of in vitro diagnostic medical devices.

24.

The examiner is usually a physician responsible for conducting the clinical trial of people in a laboratory or, in justified exceptional cases, another person whose profession is due to his scientific requirements and to the His experience in patient care is qualified to carry out research on the human being. If a test is carried out in a test site by a number of examiners, the head of the group of principal examiners shall be the responsible manager. If a test is carried out in a number of test sites, the sponsor shall appoint an auditor as the head of the clinical trial. The rates 1 to 3 shall apply for the performance assessment tests of in vitro diagnostic medical devices subject to approval.

25.

Clinical data shall be safety or performance data resulting from the use of a medical device. Clinical data come from the following sources:

a)

a clinical examination of the medicinal product concerned; or

b)

clinical trials or other studies in the scientific literature on a similar product whose similarity can be demonstrated with the medical device concerned; or

c)

published or unpublished reports on other clinical experience either with the medical device in question or on a similar product whose similarity can be demonstrated with the medical device concerned.

26.

The importer within the meaning of this Act is any natural or legal person established in the European Union who places a medical device on the market in the European Union from a third country.

Second section
Requirements for medical devices and their operation

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§ 4 Prohibitions on the protection of patients, users and third parties

(1) It is prohibited to place medical devices on the market, to establish, to operate, operate or use medical devices if:

1.

there are reasonable grounds for suspecting that they are used in the safety and health of patients, of users or of third parties in the case of proper use, maintenance and their intended use, in accordance with the findings of the -immediate or indirect risk to medical sciences, or

2.

the date has expired up to which a safe application is verifiably possible.

(2) It shall also be prohibited to place medical devices on the market if they are provided with a misleading description, indication or presentation. In particular, misleading information shall be provided where:

1.

Medical products are provided with a performance that they do not have,

2.

it is erroneously given the impression that success can be expected with certainty or that no harmful effects occur after use has been made for the intended purpose or for a longer period of time,

3.

for deception on the product characteristics defined in the basic requirements according to § 7, suitable names, indications or instructions are used which are decisive for the evaluation of the medical product.

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§ 5 Responsible for the initial placing on the market

The manufacturer or his authorised representative shall be responsible for the first placing on the market of medical devices. If medical devices are not introduced into the European Economic Area under the responsibility of the plenipotentiary, the importer shall be the person responsible. The name or company name and address of the person responsible must be included in the labelling or instructions for use of the medical device. Unofficial table of contents

§ 6 Conditions for placing on the market and putting into service

(1) Medical products, with the exception of custom-made products, medical devices made from own-production, medical devices according to § 11 (1) and medical devices intended for clinical testing or in vitro diagnostics intended for performance assessment purposes , shall be placed on the market or put into service in Germany only if they are marked with a CE marking in accordance with the first sentence of paragraph 2 and the first sentence of paragraph 3. Provisions that go beyond the requirements of the procurement or the application of medical devices remain unaffected. (2) Medical products may only be labelled with the CE marking if the basic legends are not Requirements according to § 7, which are applicable to them, taking into account their intended purpose, are fulfilled and a conformity assessment procedure prescribed for the respective medical product in accordance with the legal regulation according to § 37 (1) (1) has been carried out. Intermediate products, which are specifically designated by the manufacturer as a component for custom-made products, may be marked with the CE marking if the requirements of the first sentence are met. If the manufacturer is not established in the European Economic Area, the medical device may, in addition to the first sentence, be marked with the CE marking only if the manufacturer is responsible for a single medical device. (3) In addition, if the medical device is subject to other legislation other than that which is confirmed by the CE marking, the manufacturer shall be entitled to: Medical product is labelled with the CE marking only if these other products are also marked with the CE marking. Legislation has been complied with. If, on the basis of one or more other legislation, the manufacturer is free to choose the applicable rules during a transitional period, he shall indicate, by means of the CE marking, that this medicinal product shall be applied only to the legislation. In this case, the manufacturer shall indicate in the documents, instructions or instructions accompanying the medical device the numbers of the directives adopted by the legislation in question, under which they shall be published in the Official Journal of the European Union be published. In the case of sterile medical devices, these documents, instructions or instructions must be accessible without destroying the packaging, by means of which the sterility of the medical device is guaranteed. (4) The implementation of conformity assessment procedures shall be without prejudice to the civil and criminal responsibility of the person responsible pursuant to § 5. Unofficial table of contents

Section 7 Basic requirements

(1) The basic requirements for active implantable medical devices are the requirements of Annex 1 to Council Directive 90 /385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable devices. medical equipment (OJ L 327 17), which was last amended by Article 1 of Directive 2007 /47/EC (OJ L 189, 20.7.2007, p. 21), the requirements of Annex I to Directive 98 /79/EC for in vitro diagnostic medical devices and the requirements of Annex I to Council Directive 93 /42/EEC of 14 June 1993 for other medical devices on medical devices (OJ C 327, 1), as last amended by Article 2 of Directive 2007 /47/EC (OJ L 378, 27.12.2007, p. 21), in each of the current versions. (2) If there is a relevant risk, medical devices, including machines within the meaning of Article 2 (a) of Directive 2006 /42/EC of the European Parliament and the Council of 17 May 2006 on machinery (OJ C 139, 14.6.2006, p. 24) also comply with the essential health and safety requirements laid down in Annex I to that Directive, provided that these basic health and safety requirements are more specific than those laid down in Annex I to the Directive. Essential requirements set out in Annex I to Directive 93 /42/EEC or in accordance with Annex 1 to Directive 90 /385/EEC. (3) In the case of products not only manufactured by the manufacturer as a medical device, but also for use in accordance with the provisions of the personal protective equipment of Directive 89 /686/EEC must also be the relevant basic health and safety requirements of this Directive. Unofficial table of contents

§ 8 Harmonized standards, common technical specifications

(1) Medical products shall be in accordance with harmonised standards or monographies of the European Pharmacopoeia or common technical specifications which relate to the medical device concerned, shall be presumed to the extent that: comply with the provisions of this Act. (2) The Common Technical Specifications shall be complied with as a general rule. If, in duly substantiated cases, the manufacturer does not meet these specifications, he/she shall choose solutions which are at least equivalent to the level of the specifications. Unofficial table of contents

§ 9 CE marking

(1) The CE marking is for active implantable medical devices as defined in Annex 9 to Directive 90 /385/EEC, for in vitro diagnostic medical devices listed in Annex X to Directive 98 /79/EC and for other medical devices referred to in Annex XII to the Directive 93 /42/EEC. Signs or inscriptions likely to mislead third parties with regard to the meaning or graphic design of the CE marking must not be affixed. All other signs may be affixed to the medical device, the packaging or the instructions for use of the medical device, provided that it does not affect the visibility, legibility and meaning of the CE marking. (2) The CE marking must be affixed by the person who is determined in accordance with the provisions relating to conformity assessment procedures in accordance with the provisions of Article 37 (1) of the Regulation. (3) The CE marking referred to in the first sentence of paragraph 1 must be clearly visible, good readable and permanent on the medical device and, if available, on the trade package as well as on the instructions for use. The CE marking must not be affixed to the medical device if it is too small, its nature does not allow it, or it is not appropriate. The CE marking must be added to the identification number of the notified body responsible for carrying out the conformity assessment procedure laid down in Annexes 2, 4 and 5 to Directive 90 /385/EEC, Annexes II, IV, V and VI to Directive 93 /42/EEC and to Annexes III, IV, VI and VII to Directive 98 /79/EC, which has led to the authorisation to affix the CE marking. In the case of medical devices which have to bear the CE marking and are placed on the market in a sterile condition, the CE marking must be affixed to the sterile packaging and, where appropriate, to the trade pack. Where a medical device requires a conformity assessment procedure which does not have to be carried out by a notified body, the CE marking must not be added to a designation number of a notified body. Unofficial table of contents

§ 10 Conditions for the initial placing on the market and the putting into service of systems and treatment units as well as for the sterilization of medical devices

(1) Medical products bearing a CE marking and which, in accordance with their intended purpose, are assembled within the limits of the application provided by the manufacturer, for the first time in the form of a system or treatment unit. , shall not be subject to conformity assessment procedures. If you are responsible for the composition of the system or the treatment unit, you must make a statement in this case in accordance with the legal regulation pursuant to § 37 (1). (2) Included the system or the treatment unit Medical Devices or other products which do not bear the CE marking in accordance with the provisions of this Act, or where the chosen combination of medical devices is not compatible with their original purpose, the system or treatment unit shall be subject to a Conformity assessment procedures in accordance with the provisions of Article 37 (1) of the Law (3) Any system or treatment unit referred to in paragraph 1 or 2, or any other medical device bearing a CE marking, for which the manufacturer has provided for sterilisation prior to its use, shall be submitted for the first time To be sterilized, a conformity assessment procedure must be carried out in accordance with the provisions of § 37 (1) and must make a statement. This shall apply if medical devices which are used in a sterile manner are prepared after the first placing on the market and submitted to others. (4) Medical products, systems and treatment units as referred to in paragraphs 1 and 3 shall not be provided with: an additional CE marking. Those who make up or sterilize systems or units of treatment referred to in paragraph 1 and sterilize medical devices referred to in paragraph 3 shall have the medical device referred to in Article 7 of Annex 1 to Directive 90 /385/EEC, in accordance with points 11 to 15 of Annex 1 to Directive 90 /385/EEC, Points 13.1, 13.3, 13.4 and 13.6 of Annex I to Directive 93 /42/EEC or points 8.1, 8.3 to 8.5 and 8.7 of Annex I to Directive 98 /79/EC shall be accompanied by the information required by the manufacturer of the products referred to in that Directive. The system or the treatment unit has been assembled, provided with information provided . Unofficial table of contents

Section 11 Special provisions for placing on the market and putting into service

(1) By way of derogation from the provisions of Section 6 (1) and (2), the competent federal authority may, on a reasoned request, the initial placing on the market or the putting into service of individual medical devices in which the procedures are in accordance with the conditions laid down in Pursuant to Section 37 (1) of the Law on the Rights of the Law of the German Federal Republic of Germany, it is not possible to apply for a limited period of time in Germany if their application The authorisation may be extended on a substantiated request. (2) Medical products may only be submitted to the user if the information intended for him is written in German. In justified cases, another language which is easy to understand for the user of the medical device can be provided, or the information of the user can be guaranteed by other measures. However, the security-related information must be available in German or in the language of the user. (3) Regulations on the prescription of medical devices may be regulated by means of a legal regulation in accordance with § 37 para. 2, regulations on the distribution channels of medical devices are subject to legal regulation pursuant to § 37 para. 3. (3a) In-vitro diagnostics for the detection of HIV infections may only be applied to

1.

Doctors,

2.

outpatient and inpatient facilities in the health care sector, wholesalers and pharmacies,

3.

Health authorities of the Federal Government, the Länder, the municipalities and municipal associations

(4) By means of a legal regulation in accordance with Section 37 (4), regulations may be issued for establishments and facilities that place or store medical devices in Germany. Unofficial table of contents

§ 12 Special orders, medical devices from own production, medical devices for clinical testing or for performance evaluation purposes, outlining

(1) Special products may be placed on the market or put into service only if the basic requirements of Article 7 applicable to them, taking into account their intended purpose, are met and the intended purpose for them is: Conformity assessment procedures have been carried out in accordance with the provisions of Article 37 (1) of the Law. The responsible person in accordance with § 5 shall be obliged to submit to the competent authority, on request, a list of the special orders. The provisions of sentence 1 shall apply to the commissioning of medical devices from the self-manufacture according to § 3 (21) and (22). (2) Medical devices intended for clinical testing may be used for this purpose to physicians, Dentists or other persons authorised to carry out such tests on the basis of their professional qualifications shall be given only if, in the case of active implantable medical devices, the requirements of point 3.2, sentence 1 and 2 of the Annex 6 to Directive 90 /385/EEC and in the case of other medical devices, the requirements of Point 3.2 of Annex VIII to Directive 93 /42/EEC is complied with. The sponsor of the clinical trial shall at least 15 years and the documentation referred to in point 3.2 of Annex VIII to Directive 93 /42/EEC, at least five years and in the case of (3) For this purpose, in vitro diagnostic diagnostic tests may be applied to physicians, dentists, or other persons who are responsible for their professional qualifications. Qualification to carry out these tests shall be authorised only if the The requirements set out in point 3 of Annex VIII to Directive 98 /79/EC are met. The sponsor of the performance assessment test must keep the documentation referred to in point 3 of Annex VIII to Directive 98 /79/EC at least five years after the end of the examination. (4) Medical products which do not meet the requirements of § 6 para. 1 and 2 or § 10 may only be issued if a visible sign clearly indicates that they do not meet the requirements and can only be acquired if the match is established. In the case of presentations, the necessary precautions must be taken to protect persons. In vitro diagnostic medical devices issued in accordance with the first sentence may not be applied to samples taken by a visitor to the exhibition. Unofficial table of contents

§ 13 Classification of medical devices, delimitation to other products

(1) Medical products with the exception of in vitro diagnostic medical devices and active implantable medical devices are assigned to classes. The classification shall be carried out in accordance with the classification rules laid down in Annex IX to Directive 93 /42/EEC. (2) In the event of disagreement between the manufacturer and a notified body on the application of the above rules, the notified body shall: (3) The competent authority of the federal authority shall also decide, at the request of a competent authority or of the manufacturer, on the classification of individual medical devices or of the the delimitation of medical devices to other products. (4) The Competent authority shall forward all decisions concerning the classification of medical devices and the delimitation of medical devices to other products to the German Institute for Medical Documentation and Information on the Central Processing and use in accordance with § 33 (1) sentence 1. This shall apply in accordance with decisions taken by the competent authority of the Federal Government in accordance with paragraphs 2 and 3. Unofficial table of contents

§ 14 Erjudging, Operating, Applying and Maintenance of Medical Devices

Medical devices may only be constructed, operated, applied and kept in accordance with the terms of the legal regulation pursuant to § 37 (5). They must not be operated and applied if they have deficiencies which may endanger patients, employees or third parties.

Third Section
Notified bodies and certificates

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Section 15 Designation and supervision of bodies, recognition and appointment of testing laboratories

(1) The Federal Ministry of Health shall inform the Federal Ministry of Economics and Technology of the responsibilities of the competent authority for the performance of tasks relating to conformity assessment in accordance with the provisions of the law 37 (1) and their areas of responsibility, which shall be forwarded by the latter to the European Commission and to the other States Parties to the Agreement on the European Economic Area. A request for designation may be submitted to the competent authority as a notified body. The nomination shall be subject to the qualification of the body responsible for carrying out its tasks and compliance with the criteria set out in Annex 8 to Directive 90 /385/EEC, Annex XI to Directive 93 /42/EEC or Annex IX to the Directive. 98 /79/EC, in accordance with the procedures for which it is to be designated, by the competent authority in a designation procedure. The bodies which meet the criteria laid down in the national standards adopted for the implementation of the relevant harmonised standards shall be adopted in accordance with the relevant criteria. The designation may be granted subject to conditions and may be limited to a limited period. The issuing, expiry, withdrawal, revocation and expiry of the designation shall be notified to the Federal Ministry of Health without delay. (2) The competent authority shall monitor the compliance with the obligations laid down in paragraph 1 for notified bodies and Requirements. It shall take the necessary measures to remedy the shortcomings identified or to prevent future infringements. The monitoring of the notified bodies involved in the implementation of conformity assessment procedures for medical devices which produce ionizing radiation or containing radioactive substances shall be carried out on behalf of the Federal Republic of Germany by the Countries running. The competent authority may require the notified body and its staff responsible for managing and carrying out technical tasks to provide the necessary information and other assistance in order to carry out its monitoring tasks; it shall: authorized to accompany the notified body in the event of verifications. Their representatives shall be authorised to enter and inspect land and business premises, as well as test laboratories, at the operating and business hours, and shall submit documents, in particular on the issuing of certificates and proof of proof of their use. the fulfilment of the requirements of the second sentence of paragraph 1. The right of access also extends to the base of the manufacturer, as far as the monitoring takes place there. Article 26 (4) and (5) shall apply mutatis. (3) to the European Commission and to the other Member States of the European Union by a State Party to the Convention on the basis of a Council act or the European Commission. The names of the notified bodies referred to in paragraph 1 shall be placed on the same footing as the European Economic Area. (4) The German notified bodies shall be informed by the competent authority of their respective tasks and their identification number on their website. (5) As far as a notified body is responsible for the performance of its tasks, testing laboratories shall ensure that they comply with the criteria set out in Annex 8 to Directive 90 /385/EEC, in Annex XI to Directive 93 /42/EEC or in Annex IX to Directive 98 /79/EC, in accordance with the procedures for which they are responsible are to be fulfilled. The fulfilment of the minimum criteria shall be established by the competent authority in a recognition procedure. Unofficial table of contents

Section 15a Designation and monitoring of conformity assessment bodies for third countries

(1) With the designation as a conformity assessment body for third countries, a natural or legal person or a legally competent partnership is empowered to carry out tasks of conformity assessment in the field of medical devices for or for the in the context of the respective agreement of the European Community or of the European Union with third States or organisations referred to in Article 216 of the Treaty on the Functioning of the European Union. Section 15 (1) and (2) shall apply. (2) The designation as a conformity assessment body for third countries shall be based on a designation procedure carried out by the competent authority, which shall be used to empower the body responsible for the performance of its (3) The designation as a conformity assessment body for third countries may be granted subject to conditions and may be limited to a limited period. The issuing, expiry, withdrawal, revocation and expiry of the designation shall be notified immediately to the Federal Ministry of Health and to the institutions referred to in the respective agreements. Unofficial table of contents

Section 16 Erdeletion, withdrawal, revocation and revocation of the appointment

(1) The appointment shall be made with the expiry of the term of the term "Fristablauf", with the cessation of the operation of the notified body or by waiving The competent authority shall, without delay, inform the competent authority in writing. (2) The competent authority shall return the designation to the extent that it is subsequently known that a notified body does not have the right to appoint the competent authority to: the conditions for a nomination have been met; it shall revoke the appointment, in so far as the conditions for an appointment have subsequently been omitted. (3) In the cases referred to in paragraphs 1 and 2, the former notified body shall be obliged to make available all relevant information and documents to the notified body; with which the manufacturer agrees to continue the conformity assessment procedures. (4) The competent authority shall immediately inform the Federal Ministry of Health and the other competent authorities of the erasure, withdrawal and revocation of the product. in Germany, indicating the reasons for and the measures deemed necessary, . The Federal Ministry of Health shall immediately inform the Federal Ministry of Economics and Technology, which shall immediately inform the European Commission and the other Contracting States of the Agreement on the European Economic Area is informed. The deletion, withdrawal and revocation of a designation shall be made known by the competent authority on its website. (5) Paragraphs 1, 2 and 4 shall apply to conformity assessment bodies for third countries. Unofficial table of contents

Section 17 Period of validity of certificates of the notified bodies

(1) Insofar as the certificate issued by a notified body within the framework of a conformity assessment procedure in accordance with the provisions of Article 37 (1) has a limited period of validity, the period of validity of the certificate may, at the latest, be valid at the most are extended for five years. Should this notified body no longer exist or require other reasons to change the notified body, the application may be lodged with another notified body. (2) A report shall be submitted with the request for renewal, which shall: Information on whether and to what extent the assessment characteristics for conformity assessment have changed since the granting or renewal of the certificate of conformity. Unless otherwise agreed with the notified body, the application shall be submitted no later than six months before the expiry of the period of validity. Unofficial table of contents

§ 18 Restriction, suspension and withdrawal of certificates, teaching obligations

(1) Where a notified body finds that the conditions for issuing a certificate from the manufacturer are not or are no longer fulfilled, or that the certificate should not have been issued, it shall restrict it, taking into account the The principle of proportionality shall include, suspend or withdraw the certificate issued, unless the person responsible shall, by means of appropriate remedial measures, ensure that the conditions are in accordance with the conditions laid down. The notified body shall take the necessary measures without delay. (2) Before taking a decision on a measure referred to in paragraph 1, the manufacturer shall be heard by the notified body, unless such a hearing is held in view of the urgency of the (3) The notified body shall be informed of the decision.

1.

without delay, the German Institute for Medical Documentation and Information on all exhibited, amended, amended and, together with the reasons, on all rejected, restricted, withdrawn, suspended and re-established Certificates; § 25 (5) and (6) shall apply accordingly;

2.

without delay, the competent authority of the competent authority in cases where intervention by the competent authority may prove necessary,

3.

at the request of the other notified bodies or the competent authorities, on their certificates and provide additional information, where necessary,

4.

on request, third parties on the information in certificates issued, amended, supplemented, suspended or revoked.

(4) The German Institute for Medical Documentation and Information informs about restricted, refused, suspended, re-inserted and withdrawn certificates electronically the competent authority for the responsible person in accordance with § 5 Authority, the competent authority of the Federal Government, the European Commission, the other States Parties to the Agreement on the European Economic Area, and shall provide the notified bodies with the possibility of access to this information.

Fourth Section
Clinical evaluation, performance assessment, clinical trial, performance review

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§ 19 Clinical Evaluation, Performance Evaluation

(1) The suitability of medical devices for the intended use is to be proven by a clinical evaluation based on clinical data in accordance with § 3, point 25, unless other data are sufficient in justified exceptional cases. The clinical evaluation shall include the assessment of adverse effects as well as the acceptability of the benefit/risk ratio as referred to in the basic requirements of Directives 90 /385/EEC and 93 /42/EEC. The clinical evaluation shall be carried out in accordance with a defined and methodically sound procedure and shall, where appropriate, take into account relevant harmonised standards. (2) The suitability of in vitro diagnostic medical devices for the intended use is through a performance assessment on the basis of appropriate data. The performance assessment shall be based on:

1.

data from the scientific literature covering the intended use of the medical device and the techniques used in the process, as well as a written report containing a critical assessment of such data; or

2.

the results of all performance assessment tests or other appropriate tests.

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§ 20 General requirements for clinical examination

(1) The clinical examination of a medical device may only be initiated in Germany if the relevant Ethics Committee assesses them in accordance with § 22 and the competent authority of the Federal State of Ethics (Bundesoberbehörde), according to § 22a has been approved. In the case of clinical trials of medical devices with a low safety risk, the competent authority of the Federal Republic of Germany may depart from a permit. The details of this procedure are laid down in a legal regulation in accordance with Section 37 (2a). The clinical examination of a medical device may only be performed in humans, if and as long as

1.

the risks associated with it for the person at which it is to be carried out, as measured by the probable significance of the medical device for the medical certificate, are medically justifiable,

1a.

a sponsor or a representative of the sponsor who has its head office in a Member State of the European Union or in another State Party to the Agreement on the European Economic Area,

2.

the person in which he is to be carried out has given his/her consent to this, after having received a doctor, medical device intended for dentistry, including through a dentist, nature, significance and scope of clinical trials. The examination has been clarified and, with this consent, at the same time, declares that it shall be carried out by the contracting authority with the record of health data as part of the clinical trial and with the inspection for examination purposes. or the competent authority,

3.

the person in which the person is to be carried out is not kept in a judicial or administrative order in an institution;

4.

carried out in a suitable facility and by a suitably qualified examiner, and by a suitably qualified and specialized medical practitioner, in the case of medical devices intended for dentistry, also by a dentist, or by a dentist, any other suitably qualified and authorized person who can demonstrate at least two years ' experience in the clinical examination of medical devices,

5.

where necessary, a biological safety assessment or other test necessary for the intended purpose of the medical device has been carried out in accordance with the relevant scientific findings,

6.

to the extent necessary to demonstrate safety safety for the use of the medical device, taking into account the state of the art, as well as the occupational safety and accident prevention regulations,

7.

the auditors have been informed of the results of the biological safety assessment and of the technical safety test and the risks likely to be associated with the clinical trial,

8.

there is a test plan corresponding to the relevant state of scientific knowledge; and

9.

where a person is killed or the body or the health of a person is injured or impaired in the conduct of the clinical trial, insurance is provided in accordance with paragraph 3, which also provides benefits, if no other is liable for the damage.

(2) The consent referred to in paragraph 1 (2) shall be effective only if the person who gives it is effective,

1.

Capable and able to identify the nature, risks, importance and scope of the clinical trial and to determine its will, and

2.

has given the consent itself and in writing.

A consent can be revoked at any time. (3) The insurance referred to in paragraph 1 (9) must be taken in favour of the person affected by the clinical trial in a insurer authorized to operate in Germany. Its scope shall be proportionate to the risks associated with the clinical trial and shall be determined on the basis of the risk assessment in such a way as to ensure that, in any event, the death or invalidity of the invalidity of any of the risks arising from the clinical trial must be assessed in such a way as to be the person concerned is at least 500 000 euro available to the clinical trial. (4) In the case of a clinical trial in the case of minors, paragraphs 1 to 3 shall apply, subject to the following conditions:

1.

The medical device must be intended for detection or prevention of diseases in the case of minors.

2.

The application of the medical device must be indicated according to the findings of medical science, in order to identify diseases in the case of the minor or to protect him from diseases.

3.

According to medical science, clinical trials in adults must not be expected to provide sufficient test results.

4.

The consent is given by the legal representative or supervisor. It is effective only if the latter has been informed by a doctor, in the case of medical devices intended for dentistry, also by a dentist, on the nature, significance and scope of the clinical trial. If the minor is able to see the nature, significance and scope of the clinical trial and to determine his will, his written consent shall be required.

(5) In the case of pregnant or breast-feeding clinical trials, paragraphs 1 to 4 shall apply, subject to the following conditions: clinical trials may be conducted only if:

1.

the medical device is intended to prevent, detect, heal or alleviate diseases in pregnant or breast-feeding women or in an unborn child,

2.

the application of the medical device is indicated according to the findings of medical science in order to detect diseases or their course in the pregnant or breast-feeding woman or in an unborn child, to cure or to cure diseases or to or the pregnant or breastfeeding woman, or the unborn child, to protect from disease,

3.

According to the findings of medical science, the conduct of the clinical trial for the unborn child cannot be expected to be exposed to undue risks, and

4.

the clinical examination according to the findings of medical science can only be expected if it is carried out on pregnant or breast-feeding women.

(6) (dropped) (7) (dropped) (8) (dropped) Unofficial table of contents

Section 21 Special requirements for clinical examination

§ 20 (1) to (3) shall apply to a clinical trial in the case of a person suffering from a disease to which the medical device to be tested is to be applied, subject to the following conditions:

1.

The clinical trial shall be conducted only if the medical science findings of the medicinal product to be tested are indicated in order to save the life of the patient, to restore or to restore his or her health. Make it easier to suffer.

2.

The clinical trial may also be carried out with a person who is incapaciated or limited in business capacity. They shall require the consent of the legal representative. In addition, the consent of the representative is also required if he is able to see the nature, significance and scope of the clinical trial and to determine his will.

3.

The consent of the legal representative shall only be effective if the latter has been informed by a doctor, in the case of medical devices intended for dentistry, also by a dentist, on the nature, significance and scope of the clinical trial. Section 20 (2) sentence 2 shall apply to the revocation. The consent of the legal representative shall not be required for as long as a treatment without delay is necessary in order to save the life of the patient, to restore his or her health or to facilitate his suffering, and to make a statement on: the consent cannot be obtained.

4.

The consent of the sick person or the legal representative is also effective if it is oral to the treating physician, in the case of medical devices intended for dentistry, also in relation to the treating dentist, in the presence of a witness. , which was also included in the information of the person concerned. The witness shall not be a person employed by the test office and not a member of the test group. The oral consent is to be documented in writing, dated and signed by the witness.

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Section 22 Procedure with the Ethics Committee

(1) The additional evaluation of the Ethics Committee required in accordance with § 20 (1) sentence 1 shall be requested by the sponsor in the independent interdisciplinary Ethics Committee, which is responsible for the auditor under national law. If the clinical trial is carried out by a number of examiners, the application shall be submitted to the independent Ethics Committee responsible for the principal auditor or head of the clinical trial. In the case of multicentre clinical trials, a vote is sufficient. The information on the education, composition and funding of the Ethics Committee is determined by national law. The sponsor shall submit to the Ethics Committee all the particulars and documents required for evaluation. In order to evaluate the documents, the Ethics Committee may use its own scientific findings, provide expert advice or request expert opinions. It shall consult experts or request expert opinions if it is a clinical trial in the case of minors and does not have their own expertise in the field of paediatrics, including ethical and psychosocial Questions of paediatrics. The procedure will be settled in a legal regulation pursuant to § 37 paragraph 2a. (2) The Ethics Committee has the task of advising and consulting the test plan and the necessary documents, in particular according to ethical and legal aspects. check whether the requirements of § 20 (1) sentence 4 (4) to (4) and (7) to (9) and (4) and (5) and in accordance with § 21 are fulfilled. (3) The additional evaluation may only be denied if:

1.

the documents submitted are incomplete, even after the expiry of a reasonable time limit set by the sponsor;

2.

the documents submitted, including the test plan, the test information and the modalities for the selection of subjects, do not correspond to the state of scientific knowledge, and in particular the clinical trial is unsuitable for: proof of the safety, performance or effect of the medical device, or

3.

which are not fulfilled in § 20 (1) sentence 4 (1) to (4) and (7) to (9), as well as (4) and (5), and the requirements referred to in Article 21.

(4) The Ethics Committee shall forward a decision on the application referred to in paragraph 1 within a period of 60 days after receipt of the required documents. It shall also inform the competent federal authority of the decision. Unofficial table of contents

Section 22a Approval procedure for the Federal Authority

(1) The required authorisation pursuant to § 20 (1) sentence 1 shall be requested by the sponsor at the competent federal authority. The application must, with the exception of the opinion of the Ethics Committee concerned, in the case of active implantable medical devices, the information referred to in point 2.2 of Annex 6 to Directive 90 /385/EEC and, in the case of other medical devices, the information provided for: Point 2.2 of Annex VIII to Directive 93 /42/EEC. In addition, the sponsor has to submit all the information and documents required by the competent federal authority for evaluation. The opinion of the Ethics Committee is to be followed up. The competent federal authority has the task, the test plan and the necessary documents, in particular according to scientific and technical aspects, to be dealt with in accordance with the legal regulation. to verify that the conditions set out in § 20 (1) sentence 4 (1), (5), (6) and (8) are fulfilled. (3) The authorisation may only be denied if:

1.

the documents submitted are incomplete, even after the expiry of a reasonable time limit set by the sponsor;

2.

the medical device or the documents submitted, in particular the information on the test plan, including the test information, are not in accordance with the state of scientific knowledge, and in particular the clinical trial is unsuitable for: proof of the safety, performance or effect of the medical device, or

3.

the requirements referred to in the first sentence of Article 20 (1) (1), (5), (6) and (8) are not fulfilled.

(4) The authorisation shall be deemed to have been granted if the competent federal authority does not transmit any reasoned objection to the sponsor within 30 days of receipt of the application documents. If the sponsor has not amended the application for reasoned objections within a period of 90 days, the application shall be deemed to be rejected. (5) After a decision of the competent federal authority on the application for approval or after the expiry of the period referred to in the second sentence of paragraph 4, the submission of documents relating to the removal of the defect shall be excluded. (6) The competent federal authority shall inform the competent authorities of approved and rejected clinical trials and shall inform the competent authorities of the competent authorities of the competent authorities of the Evaluations of the Ethics Committee and inform the competent authorities of the other States Parties to the European Economic Area and the European Commission on Rejected Clinical Trials. Information is automatically provided via the information system of the German Institute for Medical Documentation and Information. Section 25 (5) and (6) shall apply accordingly. (7) The competent ethics committee shall inform the competent ethics committee of the competent ethics committee, provided that it has received information on other clinical trials for which the competent ethics committee is responsible for the approval of a clinical trial. Evaluation of the audit assessed by the Ethics Committee shall be relevant, in particular for information on aborted or otherwise prematurely completed exams. The transfer of personal data shall not be subject to the provisions of this Directive, and business and business secrets shall also be respected. The second and third sentences of paragraph 6 shall apply accordingly. Unofficial table of contents

Section 22b Revocation, revocation and revocation of the approval or the assassin

(1) The authorisation in accordance with § 22a shall be withdrawn if it is known that a reason for the failure to grant has been provided for in accordance with Section 22a (3) of the present Convention. It shall be revoked if facts subsequently arise which would justify the failure to act in accordance with Section 22a (3) (2) or (3). In the cases of sentence 1, the rest of the permit may also be arranged for a limited period of time. (2) The competent federal authority may revoke the authorisation if the circumstances of the clinical trial do not contain the information in the permit application , or if facts give rise to doubts about the safety or the scientific basis of the clinical trial. In this case, the rest of the permit may also be arranged for a limited period of time. (3) Before a decision pursuant to paragraphs 1 and 2, the sponsor shall be given the opportunity to comment within a period of one week. Section 28 (2) (1) of the Administrative Procedure Law applies accordingly. If the competent federal authority orders the revocation, the withdrawal or the revocation of the authorisation with immediate effect, it shall immediately forward this order to the sponsor. (4) If the approval of a clinical trial is withdrawn or revoked or rests, the clinical trial shall not be allowed to continue. (5) The assent assessment shall be carried out by: the relevant Ethics Committee shall be withdrawn if the Ethics Committee has subsequently become aware that a reason for failure has been found in accordance with Article 22 (3); it shall be revoked if the Ethics Committee has subsequently become aware that:

1.

the requirements for the suitability of the examiner and the test site are not met,

2.

there is no proper insurance for the proband,

3.

the modalities for the selection of the test participants are not in accordance with the state of the medical knowledge, in particular the clinical trial is unsuitable for the detection of the safety, performance or effect of the medical device provide,

4.

the conditions for the inclusion of persons pursuant to § 20 (4) and (5) or (§ 21) are not fulfilled.

Paragraphs 3 and 4 shall apply accordingly. The competent Ethics Committee shall immediately inform the competent federal authority and the other authorities responsible for the supervision, stating the reasons. (6) If the approval of a clinical trial is withdrawn, revoked or The competent authority and the authorities of the other Member States of the European Economic Area concerned shall inform the competent authorities and the authorities of the other Member States concerned of the measure taken and the reasons for their being given the reasons. The second sentence of Article 22a (6) and the second sentence shall apply accordingly. Unofficial table of contents

Section 22c Amendments after approval of clinical trials

(1) The sponsor shall indicate any change in the documentation of the competent federal authority. (2) If the sponsor intends to make a substantial change after approval of the clinical trial, he shall request that the sponsor be given the contents and the reasons for the change.

1.

at the competent federal authority, an evaluation and

2.

at the relevant Ethics Committee, an evaluation

the changes shown. (3) In particular, changes which have been made to the

1.

can have an impact on the safety of the subjects,

2.

influence the interpretation of the documents to which the conduct of the clinical trial is based, or

3.

influence the other requirements assessed by the Ethics Committee.

(4) The Ethics Committee shall give its opinion within 30 days of the date of receipt of the amendment. Section 22 (4) sentence 2 shall apply. (5) If the Ethics Committee agrees to the application and if no objection has been expressed by the competent authority within 30 days of the date of receipt of the amendment, the sponsor may review the clinical trial in accordance with the changed the test plan. In the case of conditions, the sponsor must observe these and adapt the documentation accordingly or withdraw his amendment. Section 22a (6) shall apply accordingly. § 22b shall apply for withdrawal, revocation and revocation of the approval of the federal authority pursuant to the first sentence of sentence 1. (6) Substantial changes due to measures taken by the competent federal authority shall be initiated at a clinical trial, the competent national authority shall inform the competent authorities and the competent authorities of the other States Parties to the Agreement on the European Economic Area concerned of the action taken and the reasons for them. The second sentence of Article 22a (6) and the second sentence shall apply accordingly. Unofficial table of contents

§ 23 Implementation of the clinical trial

In addition to § § 20 to 22c, the provisions of point 2.3 of Annex 7 to Directive 90 /385/EEC and for the conduct of clinical trials of other active implantable medical devices shall also apply to the conduct of clinical trials of active implantable medical devices. Medicinal products shall be subject to the provisions of point 2.3 of Annex X to Directive 93 /42/EEC. Unofficial table of contents

Section 23a Notifications on termination or termination of clinical trials

(1) Within 90 days of the end of a clinical trial, the sponsor shall report the termination of the clinical trial to the competent federal authority. (2) This period shall be reduced to 15 days upon termination of the clinical trial. The notification shall indicate all reasons for the discontinuation. (3) The sponsor shall submit the final report to the competent federal authority within twelve months of the termination or conclusion of the clinical trial. (4) In the event of a departure from the For safety reasons, the competent federal authority shall inform all the competent authorities, the authorities of the Member States of the European Economic Area and the European Commission. The second sentence of Article 22a (6) and the second sentence shall apply accordingly. Unofficial table of contents

§ 23b Exceptions to clinical trial

§ § 20 to 23a shall not apply if a clinical trial is conducted with medical devices which may bear the CE marking in accordance with § § 6 and 10, unless this test has a different purpose for the medical device to be used. In addition, invasive or other incriminating tests will be carried out. Unofficial table of contents

§ 24 Performance assessment test

§ § 20 to 23b should be applied in accordance with § § 20 to 23b for performance assessment tests of in vitro diagnostic medical devices if:

1.

an invasive sampling is carried out exclusively or in a significant additional quantity for the purpose of evaluating the performance of an in vitro diagnostic test; or

2.

in the context of the performance assessment test, invasive or other incriminating tests are carried out, or

3.

the results obtained in the performance assessment should be used for the diagnosis without being able to be confirmed by established procedures.

In the other cases, the consent of the person from which the samples are taken is required to the extent that the personal right or commercial interests of that person are affected.

Fifth Section
Monitoring and protection against risks

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Section 25 General notification requirement

(1) Who, as the person responsible for the purposes of § 5, sentence 1 and 2, has its registered office in Germany and brings medical devices to the market for the first time, with the exception of those pursuant to § 3 No. 8, has this prior to the commencend of the activity, indicating his address of the competent authority; this shall apply to establishments and establishments which are to prepare medical devices which are intended to be used in accordance with the conditions of germarm or sterile conditions only for others. (2) Those who use systems or treatment units § 10 para. 1, or sterilised these and medical devices according to § 10 para. 3 has its registered office in Germany, the competent authority shall, by giving its address, indicate the description of the medical devices in question and, in the case of systems or units of treatment, the description of the relevant medical devices before commenting the activity. (3) In accordance with § 5, sentence 1 and 2, the person responsible for his/her seat in Germany has his or her registered office in Germany and, for the first time, placing in-vitro diagnostics on the market shall indicate to the competent authority, stating his address, prior to commence the activity:

1.

the information on reagents, medical devices containing reagents and calibration and control materials, together with the common technological characteristics and analytes, as well as the appropriate information for other in vitro diagnostic medical devices,

2.

in the case of in vitro diagnostic medical devices, in accordance with Annex II to Directive 98 /79/EC and in vitro diagnostic medical devices, all information enabling the identification of these in vitro diagnostic medical devices, the analytical and, where appropriate, the diagnostic the performance data referred to in Annex I (A) (3) to Directive 98 /79/EC, the results of the performance assessment, and information on certificates,

3.

in the case of a "new in vitro diagnostic agent" within the meaning of § 3 No. 6, the indication that it is a "new in vitro diagnostic agent".

(5) The competent authority shall communicate the data referred to in paragraphs 1 to 4 to the German Institute for the Management of the European Union for the medical documentation and information on the central processing and use according to § 33. It shall, upon request, inform the European Commission and the other States Parties to the Agreement on the European Economic Area concerning indications as referred to in paragraphs 1 to 4. (6) More details on paragraphs 1 to 5 shall be governed by the Legal Regulation in accordance with § 37 (8). Unofficial table of contents

Section 26 Implementation of the monitoring

(1) Holds and facilities located in Germany where medical devices are manufactured, clinically tested, subjected to a performance assessment test, packaged, issued, placed on the market, constructed, operated, or used; or Medical devices which are intended to be used in accordance with germarm or sterile conditions shall be subject to supervision by the competent authorities. This also applies to sponsors and persons carrying out the activities referred to in the first sentence, as well as to persons and persons ' associations which collect medical devices for others. (2) The competent authority has to satisfy itself that: the rules on medical devices and advertising in the field of medical care are respected. It shall examine to an appropriate extent, with particular regard to possible risks, whether the conditions for placing on the market, for putting into service, for setting up, operating and applying are met. The second sentence shall apply in accordance with the monitoring of clinical trials and performance assessment tests, as well as for the monitoring of the preparation of medical devices which are intended to be used in accordance with the conditions of germarm or sterile conditions. The competent authority shall take the necessary measures to eliminate the infringements identified and to prevent future infringements. It may, if there are sufficient indications of an unlawful CE marking or a risk posed by the medical device, require the controller to have the medical device checked by an expert within the meaning of § 5. In the case of an in vitro diagnostic agent in accordance with Section 3 (6), it may, at any time within two years after notification in accordance with Article 25 (3) and thereafter in justified cases, submit a report on the findings of the experience gained with the (2a) The competent authorities must have the human and factual equipment necessary to carry out their duties, as well as the need for a general recognition of the State of the art of science and technology corresponding regular training of the (2b) The details of paragraphs 1 to 2a, in particular for the implementation and quality assurance of the monitoring, shall lay down a general administrative provision according to § 37a. (3) The persons responsible for monitoring Persons shall be entitled to:

1.

To enter and visit land, business premises, premises, means of transport and to prevent the risk of public safety and order, including living spaces, at the usual business hours in which an activity referred to in paragraph 1 1; the fundamental right of the inviolability of the dwelling (Article 13 of the Basic Law) is restricted in so far as it is exercised.

2.

to check medical devices, in particular to allow them to be put into service, as well as to take samples free of charge,

3.

Documents relating to the development, manufacture, testing, clinical trial, performance assessment test or acquisition, preparation, storage, packaging, placing on the market and other whereabes of medical devices, as well as on the market in the market to consult advertising material and, in duly substantiated cases, to make copies or clearings,

4.

all necessary information, in particular on the operations referred to in point 3, to be required.

(4) Those who are subject to the supervision referred to in paragraph 1 shall have the right to condoning measures referred to in the first sentence of paragraph 3 (1) to (3) and to assist the persons responsible, as well as other persons involved in the monitoring, in the performance of their duties. This includes, in particular, the obligation to make medical devices available to these persons, to allow necessary tests, to provide the necessary staff and tools, to provide information and to provide documentation (5) The information provided in the context of the monitoring of the information may refuse to answer any such questions, the answers of which may be answered by him or one of his members of the danger referred to in § 383 (1) (1) to (3) of the Code of Civil Procedure criminal prosecution or proceedings in accordance with the law on (6) Experts who examine in the context of paragraph 2 must have the expertise necessary to do so. The competent authority shall, on request, inform the Federal Ministry of Health and the competent authorities of the competent authority of the competent authority of the competent authority of the competent authority of the competent authority of the competent authority. other States Parties to the Agreement on the European Economic Area, the results of such reviews, and the measures taken. Unofficial table of contents

Section 27 Procedure in the event of unlawful and inadmissible affixing of the CE marking

(1) Where the competent authority finds that the CE marking has been unlawfully affixed to a medical device, the controller is obliged, in accordance with § 5, to lay down the conditions for the lawful affixing of the CE marking in accordance with the instructions of the competent authority must be complied with. If these conditions are not met, the competent authority shall restrict the placing on the market of this medicinal product, subject to compliance with certain conditions, to prohibit or to cause the medicinal product to be placed on the market. from the market. It shall inform the other competent authorities in Germany and the Federal Ministry of Health thereof, which shall inform the European Commission and the other Contracting States of the Agreement on the European Economic Area thereof. (2) Where a product unreasonably carries the CE marking as a medical device, the competent authority shall take the necessary measures in accordance with the second sentence of paragraph 1. (1), third sentence shall apply mutah. Unofficial table of contents

Section 28 Procedure for protection against risks

(1) The competent authority in accordance with this law shall take all necessary measures to protect the health and safety of patients, users and third parties against the dangers arising from medical devices, unless the Atomic Energy Act or any of them (2) The competent authority shall, in particular, have the power to make arrangements, including: on the closure of the establishment or establishment, to the extent that: To prevent an imminent threat to public health, safety or order. It may prohibit, restrict or prohibit the placing on the market, putting into service, operation, use of medical devices and the commencement or further conduct of clinical trials or performance assessment tests. of certain conditions, or order the recall or the assurance of medical devices. It shall inform the other competent authorities in Germany, the competent federal authority and the Federal Ministry of Health. (3) The competent authority shall establish that CE-labelled medical devices or custom-made products the health or safety of patients, users or third parties or their property may be endangled, even if they are properly installed, kept in progress or used in accordance with their intended purpose, and shall therefore take measures with the aim of taking the medical device off the market or the To prohibit or restrict the placing on the market or putting into service, it shall immediately inform the Federal Ministry of Health of the application of a safeguard clause procedure in accordance with Article 7 of Directive 90 /385/EEC, stating the reasons for the initiation of the procedure for the protection of the market, Article 8 of Directive 93 /42/EEC or Article 8 of Directive 98 /79/EC. In the light of the above, it is necessary to indicate in particular whether the non-conformity with the provisions of this Act is due to:

1.

failure to comply with the basic requirements;

2.

an inadequate application of harmonised standards or common technical specifications, provided that the application is claimed; or

3.

a lack of harmonised standards or common technical specifications themselves.

(4) The competent authority may arrange for all those likely to be exposed to a risk posed by a medical device to be notified in a timely manner of such danger. A public warning shall be admissible if, in the event of danger, other equally effective measures may not be taken or cannot be taken in good time. (5) Measures provided for in Article 14b of Directive 93 /42/EEC and Article 13 of the Directive 98 /79/EC meets the Federal Ministry of Health by means of a regulation in accordance with § 37 (6). Unofficial table of contents

§ 29 Medical products-observation and reporting system

(1) The competent federal authority shall, in so far as not a supreme federal authority in the enforcement of the Atomic Energy Act or the legal regulations adopted pursuant to this Act, be responsible for the prevention of a danger to health or to the Safety of patients, users or third parties the risks associated with the use or use of medical devices, in particular side effects, interaction with other substances or products, contra-indications, falsifications, To centrally collect function errors, malfunctions and technical defects, to evaluate and evaluate. It shall coordinate the measures to be taken, in particular where they relate to all serious adverse events during clinical trials or performance assessment tests of in vitro diagnostic medical devices or the following events:

1.

any malfunction, failure or alteration of the characteristics or performance of a medical device, and any inaccuracy of the marking or instructions for use which, directly or indirectly, lead to death or to a serious have had or could have led to a deterioration in the state of health of a patient or of a user or of any other person,

2.

any technical or medical reason which, on the basis of the causes referred to in point 1, is caused by the characteristics and performance of a medicinal product and for the systematic recall of medical devices of the same type by the Manufacturer has led.

Section 26 (2) sentence 3 shall apply. The competent federal authority shall communicate the result of the evaluation to the competent authority which decides on the necessary measures. The competent federal authority transmits data from the observation, collection, evaluation and evaluation of risks in connection with medical devices to the German Institute for Medical Documentation and Information on Central Processing and use according to § 33. Further details of the legal regulation according to § 37 paragraph 8. (2) To the extent that this is necessary for the performance of the tasks listed in paragraph 1, the competent authorities may also name, address and date of birth of patients, users or Third parties. The competent authority referred to in paragraph 1 may, upon request, inform the competent authority of the competent authority in respect of the cases it has reported and the findings in relation to personal data. In the case of cooperation under paragraph 3, no personal data may be transmitted to patients. Sentence 3 shall also apply to the transmission of data to the information system in accordance with § 33. (3) The authority referred to in paragraph 1 shall have an effect in the performance of the tasks referred to therein with the services of the other Contracting States of the Agreement on the European Union Economic Area and the European Commission, the World Health Organisation, the health and safety authorities of other States, the health, safety and health, radiation protection and measurement and calibration authorities the competent authorities of the countries and the other competent authorities Federal authorities, notified bodies in Germany, the competent institutions of the statutory accident insurance, the Medical Service of the Federal Association of the Health Insurance Funds, the relevant specialist companies, the manufacturers and distributors as well as with other bodies which, when carrying out their tasks, cover the risks of medical devices. If there is a suspicion that an incident has been caused by an electromagnetic effect of a device other than a medical device, the Federal Office of Post and Telecommunications is to be involved. (4) Details of the implementation of the Tasks according to § 29 shall be governed by the security plan in accordance with § 37, paragraph 7. Unofficial table of contents

§ 30 Safety officer for medical devices

(1) Anyone who has its registered office in Germany as the person responsible in accordance with § 5 sentence 1 and 2 shall immediately after taking up the activity have a person with the expertise required to carry out his duties and the reliability required as a (2) The person responsible pursuant to § 5 sentence 1 and 2 shall, in so far as he does not exclusively place medical devices on the market for the first time in accordance with § 3 No. 8, the competent authority to the security officer , as well as any change in person immediately. The competent authority shall send the data in accordance with the first sentence to the German Institute for Medical Documentation and Information on the central processing and use according to § 33. (3) The proof of the required expertise as a security officer for medical devices is provided by

1.

the certificate of completed scientific, medical or technical higher education, or

2.

other training capable of carrying out the tasks referred to in paragraph 4,

and at least two years of professional experience. The expertise shall be proven at the request of the competent authority. (4) The safety officer for medical devices shall collect, assess and take the necessary measures for medical devices risks. coordinate. He/she is responsible for the performance of notification obligations to the extent that they relate to medical product risks. (5) The safety officer for medical devices must not be penalised because of the performance of the tasks assigned to him. Unofficial table of contents

§ 31 Medical Product Advisor

(1) Anyone who professionally informs professionals or who is involved in the proper handling of medical devices (medical device consultants) may exercise this activity only if he or she is aware of the expertise required for the relevant medical devices and Experience for the information and, where necessary, for the instruction in the handling of the respective medical devices. This is also the case for the teleoral information. (2) The expertise of the person in question shall be

1.

has successfully completed an education in a scientific, medical or technical profession and has been trained on the relevant medical devices, or

2.

for at least one year's activity, which may also be shorter in justified cases, experience in the information on the medical devices in question and, where necessary, in the instruction to be used in the handling thereof.

(3) The medical device adviser shall, on request, demonstrate his expertise to the competent authority. He has the latest knowledge about the respective medical devices in order to be able to advise in a knowledgeable way. The client has to provide for regular training of the medical device consultant. (4) The medical device consultant has notifications from members of the professional circles about side effects, mutual influence, malfunctions, technical Record defects, contra-indications, falsifications or other risks in the case of medical devices in writing and submit them in writing immediately to the person responsible pursuant to § 5 sentence 1 and 2 or to his safety officer for medical devices.

Sixth Section
Competent authorities, legal regulations, other provisions

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§ 32 Tasks and responsibilities of the Federal Supreme Authorities in the Medical Devices Sector

(1) The Federal Institute for Drugs and Medical Devices is responsible in particular for:

1.

the tasks referred to in Article 29 (1) and (3),

2.

the assessment of the technical and medical requirements and the safety of medical devices, unless the law requires otherwise or other federal authorities are competent,

3.

Approvals of clinical trials and performance assessment tests in accordance with § § 22a and 24,

4.

Decisions on the delimitation and classification of medical devices according to § 13 (2) and (3),

5.

Special authorisations pursuant to Article 11 (1) and

6.

advising the competent authorities, the persons responsible in accordance with § 5, the sponsors and the notified bodies.

(2) The Paul-Ehrlich-Institut shall be responsible for the tasks referred to in paragraph 1, in so far as it concerns in vitro diagnostic medical devices referred to in Annex II to Directive 98 /79/EC for testing the safety or tolerability of blood or blood or blood or blood. Tissue donations are intended to affect infectious diseases or diseases. At the Paul-Ehrlich-Institut, a subject-independent test laboratory can be set up, which can cooperate with the designated bodies and other organisations. (3) The Physikalisch-Technische Bundesanstalt is responsible for the securing of the Uniformity of the measurement system in medicine and has

1.

Evaluate medical devices with a measuring function and, in so far as it is designated in accordance with § 15, to carry out type-examination tests,

2.

Reference measurement methods, standard measuring instruments and test aids to be developed and tested on request; and

3.

to provide scientific advice to the competent authorities and notified bodies.

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Section 33 Database-based information system, European database

(1) The German Institute for Medical Documentation and Information shall establish an information system on medical devices to support the implementation of this law and shall provide the federal authorities responsible for medical devices and the competent authorities of the Federal Republic of Germany. Countries providing the necessary information for this purpose. It shall make available the necessary data for the European database within the meaning of Article 10b of Directive 90 /385/EEC, Article 14a of Directive 93 /42/EEC and Article 12 of Directive 98 /79/EC. The provision of this information for non-public bodies is permitted, insofar as this is provided for in the legal regulation pursuant to § 37 (8). It may require charges for its services. These are set out in a catalogue of fees, which requires the approval of the Federal Ministry of Health. (2) For the purposes of paragraph 1, the institute mentioned therein shall in particular have the following tasks:

1.

central processing and use of information in accordance with § 25 (5), also in conjunction with § 18 para. 3, § § 22a to 23a and 24,

2.

central processing and use of basic information on medical devices placed on the market,

3.

central processing and use of data from the observation, collection, evaluation and evaluation of risks associated with medical devices,

4.

Information gathering and transmission of data to databases of other Member States and institutions of the European Union and of other States Parties to the Agreement on the European Economic Area, in particular in connection with the Detection and prevention of risks associated with medical devices,

5.

Establishment and maintenance of access to databases that have a reference to medical devices.

(3) The institution referred to in paragraph 1 shall take the necessary measures to ensure that data are transmitted to, or access to, authorised persons only to those who are authorised to do so. Unofficial table of contents

Section 34 Export

(1) At the request of a manufacturer or authorised representative, the competent authority for export shall issue a certificate of the transport capacity of the medical device in Germany. (2) Medical products subject to a prohibition in accordance with § 4 (1), may be exported only if the competent authority of the country of destination has approved the import, after having been informed by the competent authority of the reasons for the prohibition. Unofficial table of contents

§ 35 Fees and charges

Fees and costs shall be levied in accordance with the provisions of Section 37 (9) of the Law for individually attributable public services in accordance with this Act and the legal regulations issued for the implementation of this Act. Unofficial table of contents

Section 36 Cooperation between the authorities and the notified bodies in the European Economic Area and the European Commission

The competent authorities and notified bodies responsible for carrying out the medical device law shall cooperate with the competent authorities and notified bodies of the other States Parties to the Agreement on the European Economic Area and the European Economic Area. The Commission shall provide each other with the information necessary to ensure uniform application of the provisions adopted for the implementation of Directives 90 /385/EEC, 93 /42/EEC and 98 /79/EC. Unofficial table of contents

Section 37 Regulation

(1) The Federal Ministry of Health is hereby authorized, in order to implement legal acts of the European Community or of the European Union, by means of a regulation laying down the conditions for the issue of the certificates of conformity, which shall: Implementation of the conformity assessment procedures and their assignment to classes of medical devices as well as special procedures for systems and treatment units to be regulated. (2) The Federal Ministry of Health is authorized to act by means of a legal regulation for medical devices that

1.

the health of humans, even in the case of their intended use, may endanger, directly or indirectly, if they are used without medical or dental supervision, or

2.

are often not used to a considerable extent in accordance with their intended purpose, if they thereby directly or indirectly endanger the health of human beings,

to prescribe the prescription. The German Federal Ministry of Health empowers the Federal Ministry of Health to establish rules for the proper conduct of the clinical trials and the clinical trials. To meet the requirements of an approved performance assessment test and to obtain the scientific knowledge of the relevant documents. In particular, provisions may be adopted in the regulation on:

1.

Tasks and responsibilities of the sponsor, auditor or other person conducting or controlling clinical trials, including display, documentation and reporting requirements, in particular serious adverse reactions events which may occur during the examination and which could affect the safety of the study participants or the conduct of the study,

2.

Tasks and procedures in the case of ethics committees, including the documents to be submitted, including information on the appropriate participation of women and men as participants in the examination, the interruption, renewal or Reduction of the time limit for processing and the special requirements for the ethics committees in the case of clinical trials in accordance with § 20 (4) and (5) and § 21,

3.

the tasks of the competent authorities and the regulatory approval procedure, including the documents to be submitted, including information on the appropriate participation of women and men as participants in the examination and of the relevant documents, and the the interruption or extension or reduction of the period of processing, the procedure for the verification of documents in establishments and facilities, the conditions and the procedure for the withdrawal, revocation and revocation of the authorisation, or -a clinical trial,

4.

the requirements for testing equipment and the keeping and keeping of evidence,

5.

the transfer of the name and seat of the sponsor and of the auditor responsible and of the non-personal information to the clinical trial from the competent authority to a European database;

6.

the way in which documents are forwarded and the decisions to be made to the competent authorities and the ethics committees responsible for the auditors are determined,

7.

Special regulations for medical devices with low safety risk.

(3) The Federal Ministry of Health is authorized to prescribe distribution channels for medical devices by means of a decree, insofar as it is necessary to obtain the required quality of the medical device or to obtain the necessary quality during the delivery or application of the product. requirements for the safety of patients, users or third parties necessary for the safety of the patient. (4) The Federal Ministry of Health is empowered to enact regulations for establishments or institutions by means of a regulation (Operating regulations), the medical devices in Germany in the transport bring or store in so far as it is necessary to ensure the proper operation and quality, safety and performance of medical devices, as well as to ensure the safety and health of patients, users and third parties, not at risk. The Regulation may, in particular, provide for the storage, purchase, distribution, information and consultation, as well as the instruction in the establishment, including the function test after installation and the application of the Medical devices. The regulations may also be made for persons who carry out the above-mentioned activities in a professional manner. (5) The Federal Ministry of Health is authorized to do so by means of a legal regulation

1.

Set requirements for the setting up, operation, application and maintenance of medical devices, regulations on the instruction of operators and users, safety checks, functional tests, reporting requirements and details of the reporting requirements of incidents and risks, the inventory and the medical product book, as well as other requirements, to the extent that this is necessary for the safe operation and the safe use or the proper functioning of the system; maintenance is necessary,

1a.

To establish requirements for the safe treatment of medicinal products intended for use in accordance with germarm or sterile conditions, and to make arrangements for:

a)

additional requirements for conditiers, which prepare medical devices with particularly high requirements for preparation,

b)

the certification of reorganisers referred to in point (a),

c)

the requirements for the conformity assessment bodies recognised by the competent authority which carry out certifications as referred to in point (b);

2.

a)

define requirements for the quality assurance system when operating and applying in vitro diagnostic medical devices,

b)

Rules to be adopted on:

aa)

the identification and application of quality assurance standards, the procedures for drawing up directives and recommendations, the areas of application, content and responsibilities, the involvement of the parties concerned, and

bb)

the scope, frequency and procedures of the control, and the requirements for the authorities responsible for the control and the procedure for their appointment; and

c)

stipulate that the standards, guidelines and recommendations or their references are made known by the Federal Ministry of Health in the Federal Gazette,

3.

to ensure the measurement safety of medical devices with a measuring function, to determine those medical devices with a measuring function subject to metrological controls and to determine that the operator, a suitable place or the competent authority shall carry out metrological checks, as well as rules on the scope, frequency and procedure of metrological checks, the conditions, scope and procedure of recognition and Monitoring of bodies responsible for carrying out metrological checks, as well as the Duties of the operator of a medical device with measuring function in the case of metrological controls.

(6) The Federal Ministry of Health is empowered to, by means of a legal regulation, a specific medical device or a group of medical devices for reasons of health protection and safety or in the interest of public health in accordance with Article 36 of the Treaty on the Functioning of the European Union to be prohibited or to restrict its provision or subject to special conditions. (7) The Federal Ministry of Health is authorized to act on the basis of a legislative decree. Implementation of the tasks related to the Medical products-Monitoring and reporting system in accordance with § 29 of a safety plan for medical devices. This shall in particular include the tasks and cooperation of the authorities and bodies involved and the inclusion of the manufacturers and agents, importer, placing on the market and other distributors, users and operators, of the The European Commission and the other States Parties to the Agreement on the European Economic Area shall determine the measures to be taken and the measures to be taken. The safety plan may also provide details of the risk assessment and its implementation, duty of involvement of the persons responsible pursuant to § 5 Sentence 1 and 2, other traders, the user, operator and maintenance holder, details of the notification procedure and their publication, reporting, reporting, recording and storage obligations, audits and production monitors, details of the implementation of risk-prevention measures and their monitoring, as well as information requirements, means, and -routes are regulated. In addition, the security plan may contain provisions on personal data, insofar as these are recorded, processed and used within the framework of the risk-prevention system. (8) The Federal Ministry of Health is authorized to provide To regulate the correct collection, processing and use of data according to § 33 (1) and (2) by means of a legal regulation, including with regard to the nature, scope and requirements of data. This ordinance may also be used to determine the fees for the actions of this institute. (9) The Federal Ministry of Health is authorized to pay the fee for the Federal Administration by means of a legal regulation. To determine the facts of the case in accordance with § 35 and to lay down fixed rates or framework rates. The rates shall be calculated in such a way as to cover the personnel and material costs associated with the public services which are individually attributable to the public. It may be determined in the regulation that a fee may also be levied for a service which has not been brought to an end if the reasons therefor are to be represented by the person who has led the performance. (10) Federal Ministry of Health is authorized, by means of a legal regulation, to regulate the performance of obligations arising from intergovernmental agreements or to implement acts of the Council or the European Commission, the substantive areas of this law, in particular as regards safety and medical Requirements, production and other requirements for placing on the market, operating, applying, exhibiting, in particular inspections, production monitoring, certificates, marking, retention and notification requirements, (11) The legal regulations referred to in paragraphs 1 to 10 shall be adopted with the consent of the Federal Council and in agreement with the Federal Ministry for Economic Cooperation and Development (Bundesrat). Economy and technology. In agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, they shall be responsible for the production of radioactive substances or ionizing radiation, in so far as radiation protection is concerned or is a medical device. , and in agreement with the Federal Ministry of Labour and Social Affairs, insofar as occupational safety and health protection is concerned and in agreement with the Federal Ministry of the Interior, insofar as data protection is concerned. (12) The legal regulations according to paragraphs 6 and 10 do not require the approval of the Federal Council at the risk of Delay or if it is necessary to enter into force without delay in order to carry out acts of the European Community or of the European Union. The legal regulations referred to in paragraphs 1 to 3 may be adopted without the consent of the Federal Council, if unforeseen health hazards so require. Insofar as the legal regulation in accordance with paragraph 9 concerns charges and levies by federal authorities, it does not require the approval of the Federal Council. The legal regulations according to sentences 1 and 2 do not require the agreement with the respective federal ministries involved. They shall not enter into force no later than six months after their entry into force. Your period of validity can only be extended with the approval of the Federal Council. As far as radiation protection is concerned, paragraph 11 shall remain unaffected. Unofficial table of contents

§ 37a General administrative provisions

The Federal Government, with the consent of the Federal Council, shall adopt the general administrative provisions necessary for the implementation of this Act, in particular for the implementation and quality assurance of the monitoring, on the expertise of the Monitoring of persons, equipment, exchange of information and cooperation between authorities.

Seventh Section
Special provisions for the area of the Bundeswehr

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§ 38 Application and enforcement of the law

(1) This law applies to institutions that serve the purpose of supplying the Bundeswehr with medical devices. (2) In the field of the Bundeswehr, the enforcement of this law and the supervision of the respective competent authorities and the competent authorities are responsible. Experts from the Bundeswehr. Unofficial table of contents

Section 39 Exceptions

(1) Writing the basic requirements according to § 7 the indication of the decay date can be dispensed with in the case of medical devices which are handed out to the Bundeswehr. The Federal Ministry of Defence ensures that the quality, performance and safety of medical devices are guaranteed. The first sentence shall apply to medical devices submitted to the competent federal or state authorities for the purpose of civil protection and civil protection. The competent authorities shall ensure that the quality, performance and safety of medical devices are guaranteed. (2) The Federal Ministry of Defence may, in agreement with the Federal Ministry of Health, in agreement with the Federal Ministry of Health and, insofar as occupational health and safety is concerned, in agreement with the Federal Ministry of Labour and Social Affairs, in individual cases, exceptions to this Act and legal regulations adopted pursuant to this Act shall be permitted where acts of the the European Community or the European Union, and whereas this is justified in order to carry out the specific tasks and that the protection of health is preserved;

Eighth section
Criminal and penal rules

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Section 40 Criminal Code

(1) With a custodial sentence of up to three years or a fine shall be punished, who

1.

Contrary to Article 4 (1) No 1, a medical device is placed on the market, constructed, operated, operated or applied,

2.

, contrary to the first sentence of Article 6 (1), a medical device which is subject to the provisions of the Radiation Protection Regulation or the X-ray Regulation or which has been used for the production of ionizing radiation shall be placed on the market or put into service,

3.

Contrary to § 6 (2) sentence 1 in conjunction with a regulation pursuant to Section 37 (1), a medical device which is subject to the provisions of the Radiation Protection Ordinance or the X-ray Ordinance or uses ionizing radiation during its production , with the CE marking, or

4.

, contrary to § 14 sentence 2, a medical product operates or applies.

(2) The trial is punishable. (3) In particularly serious cases, the penalty is a term of imprisonment of one year to five years. A particularly serious case shall normally be provided where the offender is through one of the acts referred to in paragraph 1

1.

the health of a large number of people is at risk,

2.

the risk of death or serious injury to the body or health, or

3.

is derived from gross self-interest for itself or another asset advantage of a large scale.

(4) If the offender is negligent in the cases referred to in paragraph 1, the penalty shall be a custodial sentence of up to one year or a fine. Unofficial table of contents

Section 41 Criminal Code

A custodial sentence of up to one year or a fine shall be punished.

1.

in accordance with Article 4 (2) sentence 1 in conjunction with sentence 2, placing a medical device on the market,

2.

Contrary to the first sentence of Article 6 (1), a medical device which is not subject to the provisions of the Radiation Protection Ordinance or the X-ray Ordinance or which did not use ionizing radiation during its production brings into circulation or is in operation ,

3.

Contrary to § 6 (2) sentence 1 in conjunction with a regulation pursuant to Section 37 (1), a medical device which is not subject to the provisions of the Radiation Protection Ordinance or the X-ray Regulation or which does not produce ionizing radiation during its production have been used with the CE marking,

4.

, contrary to § 20 (1) sentence 1 or sentence 4 (1) to (6) or (9), in each case also in connection with § 20 (4) or (5) or § 21 (1) or contrary to § 22b (4), a clinical trial shall be conducted, or continue a clinical trial,

5.

contrary to § 24 sentence 1 in conjunction with § 20 (1) sentence 1 or sentence 4 (1) to (6) or (9), also in connection with § 20 (4) or (5), or contrary to § 24 sentence 1 in conjunction with Section 22b (4), with a Performance assessment test begins, performs a performance assessment test, or continues a performance assessment test, or

6.

a legal regulation in accordance with Section 37 (2) sentence 2, insofar as it refers to this penal code for a certain amount of the facts.

Unofficial table of contents

Section 42 Penal rules

(1) An administrative offence is the person who negligently deals with one of the acts referred to in § 41. (2) Contrary to the order of order, who intentionally or negligently acts

1.

Contrary to Article 4 (1) (2), a medical device is placed on the market, constructed, operated, operated or applied,

2.

Contrary to Article 9 (3), sentence 1, the CE marking does not apply correctly or not in the prescribed manner,

3.

Contrary to § 10 (1) sentence 2 or 3 sentence 1, even in conjunction with sentence 2, in connection with a legal regulation pursuant to section 37 (1), a declaration is not issued, not correct, not complete or not in good time,

4.

Contrary to § 10 para. 4 sentence 2, a medical device does not provide information,

5.

, contrary to Article 11 (2), first sentence, or paragraph 3a, of a medical device,

6.

Contrary to § 12 (1) sentence 1 in conjunction with a legal regulation pursuant to section 37 (1), a special production is placed on the market or is put into service,

7.

, contrary to Article 12 (2) sentence 1 or 3 sentence 1, issue a medical device,

8.

, contrary to Article 12 (4) sentence 1, issue a medical device,

9.

, contrary to § 12 para. 4 sentence 3, an in-vitro diagnostic aid is used,

10.

, contrary to Article 20 (1), sentence 4, no. 7 or 8, in connection with Section 21 (1), a clinical trial is carried out,

11.

, contrary to § 25 (1) sentence 1, para. 2, 3 or 4 or § 30 (2) sentence 1, an advertisement is not reimbursed, not correct, not complete or not in good time,

12.

Contrary to Article 26 (4) sentence 1, a measure is not tolerated or a person is not supported,

13.

Contrary to § 30 para. 1, a security officer shall not or not determine in time,

14.

in accordance with the first sentence of Article 31 (1), including in conjunction with the second sentence, an activity,

15.

, contrary to Article 31 (4), a communication is not, not correct, not complete or not in the prescribed manner, or not transmitted in time or not transmitted in time, or

16.

a legal regulation pursuant to § 37 (1), (2a), (3), (4) sentence 1 or 3, (5) (1), (1a), (2) (a) or (b), (b) or (3), (7) or (8) sentence 1, or of a enforceable order, is contrary to such a decree, to the extent that: The legal regulation for a particular case refers to this fine.

(3) The administrative offence can be punished with a fine of up to twenty-five thousand euros. Unofficial table of contents

Section 43 confiscation

Items to which a criminal offence pursuant to § 40 or § 41 or an administrative offence pursuant to § 42 relates may be collected. Section 74a of the Criminal Code and Section 23 of the Law on Administrative Offences shall apply.

Ninth Section
Transitional provisions

Unofficial table of contents

Section 44 Transitional provisions

(1) medical devices with expiry date submitted before 30 June 2007 for the purpose of civil protection and civil protection to the competent authorities of the federal or state governments or to carry out their special tasks to the Bundeswehr, may also be applied after expiry of the expiry date. The competent authorities shall ensure that the quality, performance and safety of medical devices are guaranteed. (2) The provisions of this Act shall apply from 13 June 2002 to medical devices within the meaning of Section 3 (3). Medical devices according to § 3 No. 3 may be placed on the market for the first time in Germany until 13 December 2005 in accordance with the regulations in force in Germany on 13 December 2000. The further placing on the market and the putting into service of the medical devices placed on the market for the first time is permissible up to 13 December 2007. (3) The provisions of § 14 and of the regulation pursuant to § 37 (5) shall apply irrespective of the following: (4) For clinical trials in accordance with § 20 and performance assessment tests in accordance with § 24 of the Medical Devices Act, which began before 20 March 2010, § § 19 up to 24 of the Medical Devices Act, as amended by the Notice of 7 August 2002 (BGBl. 3146), as last amended by Article 1 of the Law of 14 June 2007 (BGBl). (5) For clinical trials and performance evaluations in accordance with paragraph 4, the Medical Devices Safety Planning Ordinance of 24 June 2002 (BGBl. 2131), as last amended by Article 3 of the Law of 14 June 2007 (BGBl). 1066), as amended by Article 3 of the Law of 29 July 2009 (BGBl I, p. 1066), which is amended by Article 3 of the Law of 29 July 2009. I p. 2326).