Regulation On The Database-Driven 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-Regulation-DIMDIV)

Non-official Table of Contents

DIMDIV

Date of expiry: 04.12.2002

Full quote:

" DIMDI Regulation of 4. December 2002 (BGBl. 4456), which was last amended by Article 5 of the Regulation of 25 June 2008. July 2014 (BGBl. I p. 1227) "

:Last modified by Art. 5 V v. 25.7.2014 I 1227

For details, see the menu under Notes
This regulation is used for the implementation of Council Directive 93 /42/EEC of 14 June 2014. June 1993 on medical devices (OJ L 196, 27.7.1993 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 June 2001 on the European Parliament and of the Council of the European Communities 1 December 2001 (OJ C 327, 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 The European Parliament and of the Council of 19 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of the rules on information society services (OJ C EC No 37), as amended by Directive 98 /48/EC of the European Parliament and of the Council of 20 June 2000, of the European Parliament and of the Council of 20 June 1 July 1998 (OJ L 327, EC No 18), have been observed.

footnote

(+ + + text-proof from: 1.1.2003 + + +)
(+ + + Official note of the norm-provider on EC law:
Implementation of the
EWGRL 42/93 (CELEX Nr: 393L0042)
EGRL 79/98 (CELEX No: 398L0079)
Attention to
EGRL 34/98 (CELEX Nr: 398L0034) + + +)

The V has been considered to be the V v. 4.12.2002 I 4456 of the Federal Ministry of Health and Social Protection with the consent of the Federal Council. It occurs gem. Article 4, first sentence, of this V shall enter into force on 1 January 2003. Non-official table of contents

§ 1 Scope

This Regulation goverts the collection of data that is used for database-based Information system on medical devices is required, its transmission to the German Institute for Medical Documentation and Information, as well as the processing and use of the data stored in this information system. Non-official table of contents

§ 2 Electronic ads, applications and submissions

(1) Show in accordance with § § 25 and 30 (2) of the The German Institute for Medical Documentation and Information (Deutsches Institut für Medizinische Dokumentation und Information) is responsible for the implementation of this Regulation by means of a data transmission via the central collection system.(2) Paragraph 1 shall apply in accordance with
1.
Ads in accordance with Section 18 (3) (1), § 22c (1) and § 23a of the Medical Products Act and the first sentence of § 8 (2) of the Regulation on clinical trials of medical devices,
2.
Applications pursuant to § 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-supported Information system within the framework of the procedures referred to in paragraphs 1 and 2 shall keep the parties concerned on the electronic mailboxes, which shall be available to the German Institute for Medical Documentation and Information for the exchange in the Information system. Teaching duties within the information system shall be deemed to be fulfilled if the information has been sent to the corresponding electronic mailbox.(3) A nomenclature established by the German Institute for Medical Documentation and Information by means of the central collection system shall be used for the designation of medical devices. 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 to receive ads in accordance with the Medical Devices Act

(1) At the German Institute For medical documentation and information, the conditions are created, according to § 18 para. 3 no. 1, § § 25 and 30 para. 2 of the Medical Devices Act, centrally via an internet-based collection system for the competent authorities shall be accepted. 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 verify the plausibility of the data set in accordance with § 2 (1) and 2 (1) and shall ensure the necessary completion.(3) Upon completion of the examination referred to in paragraph 2, the competent authority shall release the data to the German Institute for Medical Documentation and Information for recruitment in one of the databases designated in § 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. Non-official table of contents

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

(1) § 3 The provisions of paragraph 1 shall apply in accordance with the provisions of § 22 (1) sentence 1, § 22a (1) sentence 1, § 22c (1) and (2) and § § 23a and 24 of the Medical Devices Act and § 7 (1) and § 8 (2) of the Regulation on clinical trials. Tests of medical devices to be carried out and to be carried out by the competent federal authority and the relevant Ethics Committee.(2) The competent federal authority and the relevant Ethics Committee shall immediately enter their decisions concerning applications pursuant to paragraph 1 into the database in accordance with Article 4 (1) (3). By entering its decision into the database, the relevant Ethics Committee has fulfilled the obligation to teach according to § 22 (4) sentence 2 of the Medical Devices Act.(3) In an automated procedure, the authorities responsible for the monitoring shall be informed of the decisions referred to in the first sentence of paragraph 2. Non-official table of contents

§ 4 Medical products 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)
View according to § 25 of the Medical Devices Act and
b)
View according to § 30 para. 2 of the Medical Devices Act
2.
Database with the contents of the system 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 content of Appendix 4 to this Regulation Regulation on clinical trials and performance assessment tests in accordance with § § 20 to 24 of the Medical Devices Act,
4.
Database with the contents of Appendix 5 to this Regulation on communications for the classification of a medical device or medical device Definition of other products in accordance with § 33 (2) no. 2 in conjunction with § 13 of the Medical Devices Act,
5.
Databases on the Medical Devices-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)
Messages on incidents and recalls pursuant to § 3 (1) to (4) of the Medical products-security planning regulation, the conclusion and the result of the risk assessments carried out as well as the communications that the competent federal authorities have 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 of 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 outcome of the risk assessments carried out
2) The German Institute for Medical Documentation and Information can prepare and provide databases that are accessible to the national and international level and which contain information about medical devices. Non-official table of contents

§ 5 Use of the databases

(1) In addition to the Federal Ministry of Defense and the Federal Ministry of Health The federal and state authorities responsible for medical product law, nuclear law and metrology and metrology shall be entitled to retrieve data from the databases in accordance with § 4 paragraph 1 without charge, insofar as this is carried out in order to carry out their tasks in the case of Implementation of the Medical Devices Act is required.(2) The notified bodies shall be entitled to the databases after
1.
§ 4 (1) (1) (1) (1)) a,
2.
§ 4, paragraph 1, point 2, in relation to restricted, refused, suspended, re-used, withdrawn, counterfeit, or announced by the manufacturer Certificates and
3.
§ 4 (1) (5) (a), insofar as incidents are affected by products to which they issued a certificate ,
to use it free of charges.(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 Ordinance are entitled to the databases according to § 4 Paragraph 1 (3) and (5) (b) shall be used free of charges in so far as this is necessary for the performance of their duties in the enforcement of the Medical Devices Act.(4) The databases referred to in Article 4 (1) (1) (a) and (2) shall be public. Non-official table of contents

§ 6 Data protection and data security

The data is transferred to the respective state of the art. to take measures to ensure data protection and data security, in particular to ensure the confidentiality and integrity of the data; in the case of the use of generally accessible networks, encryption methods shall be used. Non-official table of contents

§ 7 retention period

(1) Data in the database in accordance with § 4, paragraph 1, point 1, shall be based on the setting of the Placing on the market for 20 years in the database. After the expiry of this period, the data will be deleted.(2) Data in the databases referred to in § 4 (1) (2) to (5) shall be available in the database for a further 20 years after the last modification of the relevant data record. After the expiry of this period, the data will be deleted. Non-official 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 paragraph 1, point 1)
General notification requirement pursuant to § § 25 and 30 paragraph 2 MPG
General Obligation to Notify pursuant to § 25 and 30 (2) Medical Devices Act, MPG

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

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

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Annex 4 (to § 4, paragraph 1, point 3)
Clinical review/Performance assessment test according to § § 20 to 24 MPG
Clinical Investigation/Performance Evaluation according to § § 20-24 Medical Devices Act, MPG

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Appendix 5 (to § 4 paragraph 1, point 4)
Communication on the classification of a medical product or Delimitation Non-medical devices
Notice on the Classification of a Medical Device or Demarcation from other Products

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