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Regulation on the database-based information system on medical devices of the German Institute for Medical Documentation and Information

Original Language Title: Verordnung über das datenbankgestützte Informationssystem über Medizinprodukte des Deutschen Instituts für Medizinische Dokumentation und Information

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Regulation on the database-based information system on medical devices of the German Institute for Medical Documentation and Information (DIMDI-Ordinance-DIMDIV)

Unofficial table of contents

DIMDIV

Date of completion: 04.12.2002

Full quote:

" DIMDI Regulation of 4 December 2002 (BGBl. 4456), as last amended by Article 5 of the Regulation of 25 July 2014 (BGBl I). 1227).

Status: Last amended by Art. 5 V v. 25.7.2014 I 1227

For more details, please refer to the menu under Notes
This Regulation provides for the implementation of Council Directive 93 /42/EEC of 14 June 1993 on medical devices (OJ L 327, 30.4.1993, p. EC No L 169 p. 1, 1999 No OJ No L 61, p. 55, 1999. L 125 p. 42, 2001 No 8), as last amended by Directive 2001 /104/EC of the European Parliament and of the Council of 7 December 2001 (OJ L 73, 27.2.2001, p. EC 2002 No 50), and the implementation of Directive 98 /79/EC of the European Parliament and of the Council of 27 June 1997 on the implementation of the European Parliament and Council Directive October 1998 on in vitro diagnostic medical devices (OJ L 327, 28.12.1998, p. EC No L 331 p. 1, 1999 No 32, 2000 No L 124 p. 66). The obligations laid down in Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of the provisions relating to the services of The Information Society (OJ C EC No 37), as amended by Directive 98 /48/EC of the European Parliament and of the Council of 20 July 1998 (OJ L 136, 31.5.1998, p. EC No 18), have been observed.

Footnote

(+ + + Text evidence from: 1.1.2003 + + +) 
(+ + + Official note from the norm-provider on EC law:
Implementation of the
EWGRL 42/93 (CELEX Nr: 393L0042)
ERL 79/98 (CELEX Nr: 398L0079)
Consideration of
ERL 34/98 (CELEX Nr: 398L0034) + + +)

The V was adopted as Article 1 of the V v. 4.12.2002 I 4456 by the Federal Ministry of Health and Social Security with the consent of the Bundesrat. It occurs gem. Article 4, first sentence, of this V shall enter into force on 1 January 2003. Unofficial table of contents

§ 1 Scope

This Regulation regulates the collection of the data needed for the database-based information system on medical devices, its transmission to the German Institute for Medical Documentation and Information, and the processing and Use of the data stored in this information system. Unofficial table of contents

§ 2 Electronic displays, applications and submissions

(1) Ads in accordance with § § 25 and 30 (2) of the Medical Devices Act are in the way of data transmission via the central collection system at the German Institute for Medical Documentation and Information according to the annexes to this Regulation (2) Paragraph 1 shall apply mutatily to
1.
Indications according to § 18 (3) (1), § 22c (1) and § 23a of the Medical Devices Act as well as in the first sentence of Article 8 (2) of the Regulation on clinical trials of medical devices,
2.
Applications in accordance with § 22 (1) sentence 1, § 22a (1) sentence 1, § 22c (2) and § 24 of the Medical Devices Act as well as in accordance with § 7 (1) and § 8 (2) sentence 4 of the Ordination on Clinical Trials of Medical Devices.
(2a) For the transmission of sub-directions from the database-based information system in the context of the procedures referred to in paragraphs 1 and 2, the parties shall keep the electronic mail boxes listening to the German Institute for Medical documentation and information for the exchange in the information system have been named. Teaching duties within the information system are deemed to be fulfilled if the information has been sent to the corresponding electronic mailbox. (3) For the designation of medical devices, one of the German Institute for Medical Devices Use the documentation and information provided by the central collection system to use the specified nomenclature. The technical modalities of the data collection and transmission are published by the German Institute for Medical Documentation and Information on its website. Unofficial table of contents

§ 3 Central collection system for the reception of advertisements in accordance with the Medical Devices Act

(1) At the German Institute for Medical Documentation and Information, the conditions are created for the centralised use of advertisements in accordance with § 18 (3) (1), § § 25 and 30 (2) of the Medical Devices Act (Medical Devices Act) via an internet-based collection system for the competent authorities. The advertisements shall be assigned to the competent authorities by means of an automated procedure and they shall be informed immediately of the receipt of the notification. (2) The competent authorities shall examine the data set in accordance with § 2 (1) and 2 (1) (3) At the end of the examination referred to in paragraph 2, the competent authority shall give the data to the German Institute for Medical Documentation and Information for the purpose of setting it in a of the databases referred to in Article 4 (1). With the release, the authority's obligation to transfer to the German Institute for Medical Documentation and Information in accordance with the Medical Devices Act is deemed to be fulfilled. The competent authority shall inform the taxable person in accordance with paragraph 1 of the data release. Unofficial table of contents

§ 3a Central collection system for displays and applications in clinical trials and performance assessment tests

(1) § 3 (1) applies to advertisements and applications pursuant to § 22 (1) sentence 1, § 22a (1) sentence 1, § 22c (1) and (2) as well as § § 23a and 24 of the Medical Devices Act as well as in accordance with § 7 (1) and § 8 (2) of the Ordination on Clinical Tests of medical devices to be carried out and to be submitted to the competent federal authority and the relevant Ethics Committee. (2) The competent federal authority and the relevant Ethics Committee shall give their decisions on applications in accordance with paragraph 1, immediately into the database in accordance with Article 4 (1) (3). By entering its decision in the database, the relevant Ethics Commission has fulfilled the obligation to teach according to § 22, paragraph 4, sentence 2 of the Medical Devices Act. (3) In an automated procedure, the authorities that are responsible for the Monitoring and monitoring of decisions referred to in the first sentence of paragraph 2. Unofficial table of contents

§ 4 Medical Devices-Databases

(1) The German Institute for Medical Documentation and Information operates the following databases:
1.
Database containing the contents of Annexes 1 and 2 to this Regulation on
a)
Display according to § 25 of the Medical Devices Act and
b)
Advertisements pursuant to Section 30 (2) of the Medical Devices Act,
2.
Database containing the contents of Appendix 3 to this Regulation on certificates issued by the notified bodies in accordance with Section 18 (3) (1) of the Medical Devices Act,
3.
Database containing the contents of Appendix 4 to this Regulation on clinical trials and performance assessment tests in accordance with § § 20 to 24 of the Medical Devices Act,
4.
Database containing the content of Appendix 5 to this Regulation on communications relating to the classification of a medical device and/or a medical device. delimitation to other products according to § 33 paragraph 2 no. 2 in conjunction with § 13 of the Medical Devices Act,
5.
Databases on the medical device-observation and reporting system with the data according to § 29 paragraph 1 sentence 5 of the Medical Devices Act; they contain the information about
a)
Reports on incidents and recalls pursuant to § 3 (1) to (4) of the Medical Devices Safety Planning Regulation, the conclusion and the result of the risk assessments carried out, as well as the notifications submitted by the competent federal authorities in accordance with § 21 1 sentence 1 of the Medical Devices Safety Planning Regulation, or in accordance with § 21 (2) sentence 1 of the Medical Devices Safety Planning Regulation, and
b)
Reports on serious adverse events during clinical trials or performance assessment tests of in vitro diagnostic medical devices in accordance with § 3 (6) of the Medical Devices Safety Planning Regulation as well as the conclusion and the outcome of the the risk assessments carried out.
(2) The German Institute for Medical Documentation and Information can prepare and provide databases accessible to the national and international level, which contain information on medical devices. Unofficial table of contents

§ 5 Use of databases

(1) In addition to the Federal Ministry of Defence and the Federal Ministry of Health, the federal and state authorities responsible for medical product law, nuclear law, and metrology and metrology are entitled to data from the (2) The notified bodies shall have the right to access the databases in accordance with § 4 (1).
1.
Section 4 (1) (1) (a),
2.
Section 4 (1) (2) in relation to restricted, refused, suspended, re-used, withdrawn, counterfeit or manufacturer-announced certificates; and
3.
Article 4 (1) (5) (a), where incidents have been affected by products to which they issued a certificate,
(3) The ethics committees responsible pursuant to Section 22 (1) of the Medical Devices Act and the ethics committees involved in the clinical trials of medical devices pursuant to Section 3 (1) sentence 4 of the Regulation shall be entitled to: To use databases according to § 4 (1) (3) and (5) (b) free of charges to the extent that this is necessary for the performance of their tasks in the implementation of the Medical Devices Act. (4) The databases in accordance with § 4 (1) (1) (a) and (2) are public. Unofficial table of contents

§ 6 Data protection and data security

In the case of data transmission, corresponding measures shall be taken to ensure data protection and data security, which shall in particular ensure the confidentiality and integrity of the data; in the case of the data transmission, the data shall be subject to the relevant state of the art. Use of generally accessible networks shall be subject to encryption procedures. Unofficial table of contents

§ 7 retention period

(1) Data in the database pursuant to Section 4 (1) (1) shall be available in the database for a period of 20 years after the date on which the data are placed on the market. After the expiry of this period, the data will be deleted. (2) Data in the databases according to § 4 (1) number 2 to 5 will be available for 20 years in the database after the last change of the respective data record. After the expiry of this period, the data will be deleted. Unofficial table of contents

§ 8 Right of information

§ 19 of the Federal Data Protection Act is to be applied accordingly for legal persons. Unofficial table of contents

§ § 9 and 10 (omitted)

Unofficial table of contents

Appendix 1 (to § 4 (1) (1))
General notification requirement pursuant to § § 25 and 30 (2) MPG
General Obligation to Notify pursuant to § § 25 and 30 (2) Medical Devices Act, MPG

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Appendix 2 (to § 4 (1) (1))
General notification requirement pursuant to § § 25 and 30 (2) MPG
General Obligation to Notify pursuant to § § 25 and 30 (2) Medical Devices Act, MPG

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Appendix 3 (to § 4 (1) (2))
Information on certificates according to § 18 MPG
Information relating to Certificates pursuant to § 18 Medical Devices Act, MPG

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Appendix 4 (to § 4 (1) (3))
Clinical examination/performance assessment test in accordance with § § 20 to 24 MPG
Clinical Investigation/Performance Evaluation according to § § 20-24 Medical Devices Act, MPG

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Appendix 5 (to § 4 (1) (4))
Communication on the classification of a medical device or medical device Delimitation to non-medical devices
Notice on the Classification of a Medical Device or Demarcation from other Products

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