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Regulation on medical devices

Original Language Title: Verordnung über Medizinprodukte

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Regulation on Medical Devices (Medical Devices-Ordinance-MPV)

Unofficial table of contents

MPV

Date of completion: 20.12.2001

Full quote:

" Medical Devices Ordination of 20 December 2001 (BGBl. 3854), as last amended by Article 2 of the Regulation of 10 May 2010 (BGBl I). I p. 542).

Status: Last amended by Art. 2 V v. 10.5.2010 I 542

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.1.2002 + + +) 
(+ + + Official note from the norm-provider on EC law:
Implementation of the
ERL 32/2003 (CELEX Nr: 32003L0032) see V v. 13.2.2004 I 216
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 + + +)

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Input formula

Pursuant to § 37 (1), (8) and (11) of the Medical Devices Act of 2 August 1994 (BGBl. I p. 1963), which is defined by Article 1 of the Law of 13 December 2001 (BGBl. 3586), the Federal Ministry of Health, in agreement with the Federal Ministry of Economics and Technology, the Federal Ministry of Labour and Social Affairs, the Federal Ministry for the Environment, Nature Conservation and Social Affairs, has been amended. Reactor safety and the Federal Ministry of the Interior:

Section 1
Scope and general requirements for conformity assessment

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§ 1 Scope

This Regulation regulates the evaluation and determination of the conformity of medical devices with the basic requirements according to § 7 of the Medical Devices Act (conformity assessment), the special procedures for systems and treatment units and the modification of the classification of medical devices by means of acts adopted by the Commission of the European Community. Unofficial table of contents

§ 2 Biological security check

For the assessment of the biological compatibility of medical devices, biological safety tests shall be carried out with animal testing, provided that:
1.
in the case of medical devices within the meaning of Article 3 (2) of the Medical Devices Act, in accordance with 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) has been amended, as amended, or in accordance with the Medicinal Products Inspection Directives, in accordance with Article 26 of the German Medicines Act,
2.
according to harmonised standards within the meaning of Section 3 (18) of the Medical Devices Act, or
3.
according to the respective state of scientific knowledge
are required. Unofficial table of contents

§ 3 General provisions for the implementation of conformity assessment

(1) The conformity assessment shall be carried out in accordance with the provisions of paragraph 2 and § § 4 to 7 by the manufacturer. The procedures set out in Annexes 3, 4 and 6 to 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 Article 1 of Directive 2007 /47/EC (OJ L 189, 18.7.2007, p. 21), Annexes III, V, VI and VIII to Directive 98 /79/EC of the European Parliament and of the Council of 27 June 2007 on the European Parliament and of the Council of 27 June 2007 on the implementation of the European Parliament and 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 last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.7.2003, p. 1), and to Annexes III, IV, VII and VIII to Council Directive 93 /42/EEC of 14 June 1993 on medical devices (OJ L 284, 31.10.1993, p. EC No 1), as last amended by Article 2 of Directive 2007 /47/EC (OJ L 378, 27.4.2007, p. 21), in the relevant versions, may also be carried out on behalf of the manufacturer by his authorised representative within the meaning of § 3 (16) of the Medical Devices Act. (2) Insofar as the procedures are under Participation of a notified body within the meaning of Section 3 (20) of the Medical Devices Act, the manufacturer or his authorised representative shall appoint a notified body of their choice, which shall be responsible for the relevant procedure and the relevant procedures. Medical devices are named. The notified body and the manufacturer or his authorised representative shall, by common agreement, lay down the time limits for carrying out the tests and evaluations. (3) The notified body may, in the conformity assessment procedure, all the information and information (4) In the conformity assessment procedure, the results of tests and assessments which have already been carried out for the products concerned are subject to the following conditions: (5) The period of validity of Certificates issued in accordance with Annexes 2 and 5 to Directive 90 /385/EEC, Annexes III, IV and V to Directive 98 /79/EC and Annexes II, III, V and VI to Directive 93 /42/EEC shall be limited to a maximum period of five years.

Section 2
Requirements for conformity assessment procedures

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§ 4 conformity assessment procedures for active implantable medical devices

(1) For active implantable medical devices, with the exception of the products referred to in paragraphs 2 and 4, the manufacturer shall:
1.
the procedure of the EC declaration of conformity referred to in Annex 2 to Directive 90 /385/EEC, or
2.
the procedure of the EC type-examination referred to in Annex 3 to Directive 90 /385/EEC in conjunction with the EC verification procedure referred to in Annex 4 to Directive 90 /385/EEC or to the EC declaration of conformity with the construction model referred to in Annex 5 of Directive 90 /385/EEC
(2) For custom-made products, the manufacturer must issue the declaration referred to in point 2.1 of Annex 6 to Directive 90 /385/EEC and attach it to the product. The declaration shall be available for the patients referred to in this Annex. The manufacturer shall draw up the documentation referred to in point 3.1 of Annex 6 and shall take all necessary measures to ensure that the medical devices manufactured in accordance with this documentation are in conformity with this documentation. Declaration and documentation must be kept for at least 15 years. The manufacturer shall ensure, taking into account the provisions set out in Annex 7 to Directive 90 /385/EEC, to evaluate and document the experience of products in the phase downstream of the production. It shall take reasonable steps to make the necessary corrections. This includes the obligation on the part of the manufacturer to inform the competent federal authority immediately of the following events, as soon as it has become aware of it, and to make the relevant corrections:
1.
any malfunction and alteration of the characteristics or performance and any inaccuracy of the marking or instructions for use of a product which is to death or to a serious deterioration in the state of health of a product; a patient or a user may have or may have led to it;
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 the product and which has led to the systematic recall by the manufacturer of products of the same type.
(3) Anyone who processes active implantable medical devices in accordance with § 10 (3) sentence 2 of the Medical Devices Act has a procedure in accordance with Annex 4 or 5 of the Directive with regard to sterilisation and the maintenance of the functioning of the medical device. 90 /385/EEC and to issue a declaration which confirms the preparation according to a suitable validated procedure. The declaration must be kept for at least 15 years. (4) For active implantable medical devices from the production of their own, the manufacturer must issue a declaration prior to commissioning, which shall contain the following information:
1.
the name and address of the manufacturer;
2.
the data necessary for the identification of the relevant product,
3.
the assurance that the product complies with the basic requirements set out in Annex 1 to Directive 90 /385/EEC and, where appropriate, the specification of the basic requirements which have not been fully complied with, specifying the Reasons.
It shall draw up a documentation from which the production site, as well as the design, manufacture and performance of the product, including the intended performance, shall be produced, so that it is possible to assess whether it meets the basic requirements of Directive 90 /385/EEC. It shall also take all necessary measures to ensure the conformity of the manufactured medical devices with this documentation. The provisions of the second sentence of paragraph 2 shall apply accordingly. Unofficial table of contents

Section 5 Conformity assessment procedures for in-vitro diagnostic medical devices

(1) For in vitro diagnostic medical devices listed in List A of Annex II to Directive 98 /79/EC, with the exception of the products referred to in paragraph 6, the manufacturer shall:
1.
the procedure of the EC declaration of conformity (complete quality assurance system) in accordance with Annex IV to Directive 98 /79/EC, with the exception of the products referred to in paragraph 6, or
2.
the procedure of the EC type-examination referred to in Annex V to Directive 98 /79/EC in conjunction with the procedure of the EC declaration of conformity (quality assurance production) in accordance with Annex VII to Directive 98 /79/EC, with the exception of the products referred to in paragraph 6;
(2) In the case of in vitro diagnostic medical devices listed in Annex II, List B to Directive 98 /79/EC, with the exception of the products referred to in paragraph 6, the manufacturer shall:
1.
the procedure of the EC declaration of conformity (complete quality assurance system) in accordance with Annex IV to Directive 98 /79/EC, with the exception of the products referred to in paragraph 6, or
2.
the EC type-examination procedure referred to in Annex V to Directive 98 /79/EC in conjunction with the EC verification procedure referred to in Annex VI or the procedure of the EC declaration of conformity (quality assurance production) in accordance with Annex VII to the Directive 98 /79/EC, with the exception of the products referred to in paragraph 6,
(3) In the case of in vitro diagnostic medical devices, with the exception of the products listed in Annex II, the manufacturer must carry out the procedure referred to in Annex III to Directive 98 /79/EC or a procedure referred to in paragraph 1 or 2. (4) For the purposes of other in vitro diagnostic medical devices, with the exception of the products referred to in paragraph 6, the manufacturer must carry out the procedure set out in Annex III to Directive 98 /79/EC; point 6 of this Annex shall not apply. (5) The manufacturer shall: Declaration of conformity, the technical documentation referred to in Annexes III to VIII to the Directive 98 /79/EC as well as the decisions, reports and certificates of the notified bodies and submit them to the competent authorities for a period of five years from the date of manufacture of the last product on request. (6) In vitro diagnostic medical devices, which are not manufactured on an industrial scale, the manufacturer must issue a declaration prior to commissioning, containing the following information:
1.
the name and address of the manufacturer;
2.
the data necessary for the identification of the relevant product,
3.
the assurance that the product complies with the basic requirements set out in Annex I to Directive 98 /79/EC and, where appropriate, an indication of the basic requirements which have not been fully complied with, with the indication of the Reasons.
It shall draw up a documentation from which the production site, as well as the design, manufacture and performance of the product, including the intended performance, shall be produced, so that it is possible to assess whether it meets the basic requirements of Directive 98 /79/EC, and to take all necessary measures to ensure the conformity of manufactured medical devices with this documentation. The declaration and documentation shall be kept for at least five years. The own manufacturer shall ensure that the experience with products in the phase downstream is evaluated and documented and that adequate precautions must be taken to carry out the necessary corrections. The second sentence of Article 4 (2) shall apply accordingly. Unofficial table of contents

§ 6 Conformity assessment procedure for medical devices manufactured using animal tissue

(1) For medical devices manufactured using tissue of animal origin, in accordance with Article 1 (1) and (2) of Commission Directive 2003 /32/EC of 23 April 2003 (OJ L 327, 30.4.2003, p. EU No 18), as amended, the conformity assessment procedure includes the assessment of compliance with the basic requirements of Council Directive 93 /42/EEC of 14 June 1993 (OJ 1993 L 105, p. 1). EC No 1) and to the specifications set out in the Annex to Directive 2003 /32/EC, as amended. The definitions in Article 2 of Directive 2003 /32/EC must be based on the following definitions. (2) For medical devices referred to in paragraph 1, the manufacturer shall:
1.
the procedure of the EC declaration of conformity (complete quality assurance system) referred to in Annex II to Directive 93 /42/EEC; or
2.
the EC type-examination procedure referred to in Annex III to Directive 93 /42/EEC, in conjunction with the EC verification procedure referred to in Annex IV to Directive 93 /42/EEC or the EC declaration of conformity (production quality assurance) procedure, in accordance with the procedure referred to in Annex V to Directive 93 /42/EEC
, Before making such a request, it shall carry out the risk analysis and risk management procedure in accordance with the Annex to Directive 2003 /32/EC. If collagens, gelatin or tallow are used in the manufacture of medical devices, they must satisfy at least the requirements for their suitability for human consumption. (3) In the performance of their products under the procedures referred to in paragraph 2, The competent authority shall, in accordance with Article 15 of the Medical Devices Act, verify that the notified bodies shall verify that the tasks referred to in Article 5 (2) to (4) of Directive 2003 /32/EC must be met by the designated authorities. the technical requirements for an evaluation referred to in paragraphs 1 to 3. In the event that these conditions are not met, it shall revoke the accreditation and designation and shall inform the Federal Ministry of Health accordingly. (5) Paragraphs 1 to 4 shall not apply to medical devices which are not intended to use the to come into contact with the human body or to come into contact with the skin without the skin. Unofficial table of contents

Section 7 Conformity assessment procedures for other medical devices

(1) For medical devices of category III, with the exception of the products referred to in paragraphs 5 and 9, the manufacturer shall:
1.
the procedure of the EC declaration of conformity (complete quality assurance system) referred to in Annex II to Directive 93 /42/EEC; or
2.
the EC type-examination procedure referred to in Annex III to Directive 93 /42/EEC, in conjunction with the EC verification procedure referred to in Annex IV to Directive 93 /42/EEC or the EC declaration of conformity (production quality assurance) procedure, in accordance with the procedure referred to in Annex V to Directive 93 /42/EEC
(2) For medical devices of class IIb, with the exception of the products referred to in paragraphs 5 and 9, the manufacturer shall:
1.
the procedure of the EC declaration of conformity (complete quality assurance system) referred to in Annex II to Directive 93 /42/EEC, with the exception of point 4, or
2.
the procedure of the EC type-examination in accordance with Annex III to Directive 93 /42/EEC in conjunction with the EC verification procedure referred to in Annex IV or the procedure of the EC declaration of conformity (quality assurance production) in accordance with Annex V or the procedure the EC declaration of conformity (quality assurance product) in accordance with Annex VI to Directive 93 /42/EEC
(3) For medical devices of category IIa, with the exception of the products referred to in paragraphs 5 and 9, the manufacturer shall:
1.
the procedure of the EC declaration of conformity referred to in Annex VII to Directive 93 /42/EEC, in conjunction with the procedure of the EC verification referred to in Annex IV or the procedure of the EC declaration of conformity (quality assurance production) referred to in Annex V or to the procedure of the EC verification procedure Procedure of the EC declaration of conformity (quality assurance product) in accordance with Annex VI to Directive 93 /42/EEC; or
2.
the procedure referred to in paragraph 2 (1)
(4) For medical devices of category I, with the exception of the products referred to in paragraphs 5 and 9, the manufacturer shall carry out the procedure set out in Annex VII to Directive 93 /42/EEC. (5) For custom-made products, the manufacturer shall make the declaration after: Point 2.1 of Annex VIII to Directive 93 /42/EEC and shall attach to the levy special copies of classes IIa, IIb and III a copy which is identifiable by the name, acronym or numerical code of the patients must be available. It shall draw up the documentation referred to in point 3.1 of Annex VIII to Directive 93 /42/EEC and shall take all necessary measures to ensure that the medical devices manufactured in accordance with this documentation are in conformity with this documentation. Declaration and documentation shall be kept for at least five years and, in the case of implantable products, for at least 15 years. The manufacturer shall ensure that, taking into account the provisions contained in Annex X to Directive 93 /42/EEC, experience with products in the downstream phase shall be evaluated and documented and appropriate arrangements shall be made available to: meet to make the necessary corrections. § 4 Paragraph 2 sentence 7 applies accordingly. (6) For systems and treatment units pursuant to § 10 para. 1 of the Medical Devices Act, the manufacturer must issue the declaration in accordance with the first sentence of Article 12 (2) of Directive 93 /42/EEC. The declaration shall be kept for at least five years and, in the case of implantable products, for at least 15 years. For systems and treatment units according to § 10 para. 2 of the Medical Devices Act, the provisions of paragraphs 1 to 4 apply. (7) Anyone who sterilizes medical devices in accordance with § 10 para. 3 sentence 1 of the Medical Devices Act has a view to the to carry out a procedure in accordance with Annex II or V of Directive 93 /42/EEC and to make a declaration that sterilisation has been carried out in accordance with the instructions of the manufacturer. The declaration must be kept for at least five years. (8) Anyone who processes medical devices in accordance with § 10, paragraph 3, sentence 2 of the Medical Devices Act, has a position with regard to sterilization and the maintenance of the functionality of the products. to carry out a procedure in accordance with Annex II or V of Directive 93 /42/EEC and to issue a declaration which confirms the preparation in accordance with a suitable validated procedure. The declaration shall be kept for at least five years and in the case of implantable products for at least 15 years. (9) For proprietary medical devices, the manufacturer must issue a statement prior to the entry into service, the following: Information contains:
1.
the name and address of the manufacturer;
2.
the data necessary for the identification of the relevant product,
3.
the assurance that the product complies with the basic requirements set out in Annex I to Directive 93 /42/EEC and, where appropriate, an indication of the basic requirements which have not been fully complied with, specifying the Reasons.
It shall draw up a documentation from which the production site, as well as the design, manufacture and performance of the product, including the intended performance, shall be produced, so that it is possible to assess whether it meets the basic requirements of Directive 93 /42/EEC, and to take all necessary measures to ensure that the medical devices manufactured in accordance with this documentation are in conformity with this documentation. Declaration and documentation shall be kept for at least five years and, in the case of implantable products, for at least 15 years. The manufacturer shall ensure that, taking into account the provisions contained in Annex X to Directive 93 /42/EEC, the experience of products in the downstream phase is to be evaluated and documented and appropriate to make arrangements to make the necessary corrections. The second sentence of Article 4 (2) shall apply accordingly.

Section 3
Changes in the classification of medical devices

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§ 8 breast implants

Article 13 (1), second sentence, of the Medical Devices Act, in conjunction with Annex IX to Council Directive 93 /42/EEC of 14 June 1993 on medical devices (OJ L 136, 30.4.1993, p. EC No 1), as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. EU No 1), as amended, does not apply to breast implants. Breast implants are assigned to class III. Unofficial table of contents

Final formula

The Federal Council has agreed. Unofficial table of contents

§ 9 Joint replacement for hips, knees and shoulder

(1) § 13 (1) sentence 2 of the Medical Devices Act, in conjunction with Annex IX to Council Directive 93 /42/EEC of 14 June 1993 on medical devices (OJ L 136, 30.4.1993, p. EC No 1), as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. EU No 1), as amended, does not apply to joint replacement parts for hip, knees and shoulder. Joint replacement parts for hip, knee and shoulder are assigned to class III. (2) An articular replacement part for hip, knee and shoulder is an implantable set of parts intended for this purpose, together with the function of the natural hip, To fulfill the knee or shoulder joint as completely as possible. These do not include accessories.

Section 4
Transitional provisions

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§ 10 Transitional provision for medical devices manufactured using animal tissue

Medical devices within the meaning of § 6, for which an EC certificate of approval or EC type-examination certificate issued before 1 April 2004 is available, may only be placed on the market by the person responsible pursuant to § 5 of the Medical Devices Act where there is an additional EC type-examination certificate or EC type-examination certificate certifying compliance with the specifications set out in the Annex to Directive 2003 /32/EC. Unofficial table of contents

§ 11 Transitional provisions for joint replacement for hip, knees and shoulder

(1) Medical devices within the meaning of Article 9 (2), for which a conformity assessment procedure has been carried out in accordance with Article 7 (2) No. 1, may be placed on the market and put into service after 1 September 2009 only if the manufacturer has to at this point in time for these medical devices, either
a)
a supplementary conformity assessment in accordance with Annex II, point 4 (EC certificate of approval) of Directive 93 /42/EEC, or
b)
the procedure of the EC type-examination in accordance with Annex III to Directive 93 /42/EEC in conjunction with the EC verification procedure referred to in Annex IV or the procedure of the EC declaration of conformity (quality assurance production) in accordance with Annex V
(2) Medical devices within the meaning of Article 9 (2), for which the procedure of the EC type-examination in accordance with Annex III to Directive 93 /42/EEC in conjunction with the EC declaration of conformity (quality assurance product) in accordance with Annex VI to the Directive 93 /42/EEC, may be placed on the market after 1 September 2010 only if the manufacturer either has to provide for such medical devices by that date.
a)
the procedure of the EC type-examination in accordance with Annex III to Directive 93 /42/EEC in conjunction with the EC verification procedure referred to in Annex IV or the procedure of the EC declaration of conformity (quality assurance production) in accordance with Annex V to the Directive 93 /42/EEC or
b)
the procedure of the EC declaration of conformity (complete quality assurance system) in accordance with Annex II to Directive 93 /42/EEC
has been performed. Medical devices as set out in the first sentence of the first sentence may also be put into service after 1 September 2010.