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

Read the untranslated law here: http://www.gesetze-im-internet.de/dimdiv/BJNR445610002.html

Regulation on the database-driven information system on medical devices of the German Institute for medical documentation and information (DIMDI regulation - DIMDIV) DIMDIV Ausfertigung date: 04.12.2002 full quotation: "DIMDI Decree of 4 December 2002 (BGBl. I S. 4456), most recently by article 5 of regulation from 25 July 2014 (BGBl. I p. 1227) has been changed" stand: last amended by article 5 V v. 25.7.2014 I 1227 for details on the stand number you find in the menu under instructions this regulation serves the implementation of Directive 93/42/EEC of the Council of 14 June 1993 concerning medical devices (OJ EC No. L 169 p. 1, 1999 No. L 61 S. 55, 1999 No. L 125 S. 42, 2001 No. L 72 p. 8), as last amended by Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 (OJ EC 2002 No. L 6, p. 50), and the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices (OJ EC No. L 331 S. 1, 1999 No. L 74 p. 32, 2000 No. L 124, p. 66). The obligations under the Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 establishing an information procedure in the field of technical standards and regulations and of the rules for the services of the information society (OJ EC No. L 204, p. 37), as amended by Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 (OJ EC No. L 217, p. 18), have been observed.
Footnote (+++ text detection from: 1.1.2003 +++) (+++ official note of the standard authority on EC law: implementation of EWGRL 42/93 (CELEX Nr: 393 L 0042) EGRL 79/98 (CELEX Nr: 398 L 0079) accordance with the EGRL of 98 at the 34 (CELEX Nr: 398 L 0034) +++) the V 1 V v. rightous was adopted as article I 4456 by the Federal Ministry of health and social security with the consent of the Federal Council. You as per article 4 set 1 of this V on 1 January 2003 into force.

Article 1 scope this regulation lays down the collection of data needed for the database-driven information system on medical devices, their submission to the German Institute for medical documentation and information as well as the processing and use of the data stored on this information system.

Electronic displays, applications and teachings (1) viewing article 2 according to the § § 25 or 30 (2) of the medical devices act are in the way of data transfer via the central recording system at the German Institute for medical documentation and information in accordance with the annexes to this regulation to carry out.
(2) paragraph 1 shall apply accordingly for 1 ads according to § 18 paragraph 3 No. 1, section 22 c paragraph 1 and Section 23a of the medical product law and according to § 8 paragraph 2 sentence 1 of the Ordinance on clinical trials of medical devices, 2. amendments to section 22 paragraph 1 sentence 1, § 22a, paragraph 1, sentence 1, § 22 c (2) and section 24 of the medical product law and according to article 7, paragraph 1 and article 8 paragraph 2 sentence 4 of the Ordinance on clinical trials of medical devices.
(2a) for the transmission of teachings from the database-driven information system within the framework of the procedures referred to in paragraph 1 and 2 the parties keep ready to receive the electronic mailboxes, have been named to the German Institute for medical documentation and information exchange in the information system. Notification obligations shall be deemed within the information system if the information to the corresponding electronic mailbox was sent.
(3) for the label of medical devices is one of the German Institute for medical documentation and information by means of the central recording system to use prescribed nomenclature. The German Institute for medical documentation and information on its website published the technical modalities of the data collection and delivery.

Article 3 central recording system to receive ads according to the medical product law (1) at the German Institute for medical documentation and information are created the conditions for viewing according to § 18 para 3 No. 1, sections 25 and 30 para 2 of the medical devices act centrally via a Web-based data entry system for the competent authorities to accept. Associate the ads through an automated process with the competent authorities and these are immediately informed of the receipt of the notification.
(2) the competent authorities verify that according to article 2, paragraph 1 and 2 number 1 data provided on plausibility and ensure the necessary completion.
(3) upon completion of the examination referred to in paragraph 2, the competent authority releases the data to the German Institute for medical documentation and information about the setting in one of the databases mentioned in article 4, paragraph 1. With the release, the delivery obligation of the authority of the German Institute for medical documentation and information is according to the medical product law met. The competent authority shall inform the notifiable pursuant to paragraph 1 of the data release.

§ 3a central recording system for ads and applications at clinical and performance evaluation tests (1) § 3 paragraph 1 applies to ads and applications according to section 22 paragraph 1 sentence 1, § 22a paragraph 1, sentence 1, § 22 c paragraph 1 and 2 as well as the sections 23a and 24 of the medical product act as well as article 7, paragraph 1 and article 8 paragraph 2 of the Ordinance on clinical trials of medical devices , to perform at the competent federal authority and the competent Ethics Commission and to make.
(2) the competent federal authority and the responsible Ethics Commission enter immediately number 3 their decisions on applications referred to in paragraph 1 in the database pursuant to § 4 paragraph 1. With the input of its decision in the database, the competent Ethics Commission has fulfilled the duty to inform according to § 22 paragraph 4 sentence 2 of the medical product law.
(3) in an automated process, the authorities which are responsible for the monitoring, be informed of decisions referred to in paragraph 2 sentence 1.

§ 4 medical databases (1) the German Institute for medical documentation and information operates the following databases: 1 database with the contents of the systems 1 and 2 to this Ordinance, a) ads according to § 25 of the medical product law and b) show according to § 30 para 2 of the medical devices act, 2 databases with the contents of the annex 3 to this regulation on certificates of notified bodies according to § 18 para 3 No. 1 of the medical devices act , 3 database with the contents of annex 4 to this regulation on clinical trials and performance evaluation tests according to the articles 20 to 24 of the medical devices act, 4. database with the contents of Appendix 5 to this regulation through releases to the classification of a medical device or differentiation from other products according to § 33 para 2 No. 2 in conjunction with § 13 of the medical devices act, 5 databases to the medical - monitoring and reporting system with the data according to § 29 paragraph 1 sentence 5 of the medical product law. (they contain the details of a) messages about events and callbacks according to § 3 paragraph 1 to 4 of the medical security plan regulation, concluding and the result of the performed risk assessments and the releases, which provide federal upper authorities according to article 21, paragraph 1, sentence 1 of the medical security plan regulation or obtain under § 21 paragraph 2 sentence 1 of the medical security plan regulation, b) messages to serious adverse events of during clinical testing or performance evaluation studies of in vitro diagnostics in accordance with § 3 paragraph 6 of the medical security plan regulation as well as the conclusion and the result of the conducted risk assessments.
(2) can the German Institute for medical documentation and information nationally and internationally accessible databases that contain information about medical products, prepare to use and deploy.

§ 5 are use of databases (1) in addition to the Federal Ministry of defence and the Ministry of health, the medical product law, nuclear law and the calibration and Metrology authorities of the Federal and State Governments, entitled free of charge to retrieve data from the databases according to § 4 paragraph 1, insofar as this is necessary for the performance of their duties in the implementation of the medical product law.
(2) the notified bodies are entitled, the databases after 1 § 4 paragraph 1 number 1(a), 2. § 4 paragraph 1 number 2 in respect of restricted, denied, suspended, again employed, retired, fake or announced by the manufacturer certificates and 3 § 4 paragraph 1 number 5 letter a, as far as events with products are affected, to whom you have issued a certificate , free of charge to use.
(3) according to article 22, paragraph 1, of the medical product law competent ethics committees and according to § 3 paragraph 1 sentence 4 of the Ordinance on clinical trials of medical devices involved ethics committees are entitled, the databases according to § 4 paragraph 1 number 3 and 5 free of charge to use letter b, as far as this is necessary for carrying out their duties in the implementation of the medical product law.
(4) the data banks pursuant to § 4 paragraph 1 number 1(a) and paragraph 2 are public.

§ 6 data protection and data security
Data transmission are the respective State of the art measures to ensure data protection and data security to meet, providing in particular the confidentiality and integrity of the data; in the case of the use of accessible networks are encryption methods to use.

§ 7 data in the database according to § 4 paragraph 1 No. 1 are retention period (1) after setting the placing on another 20 years in the database available. After this period, the data is deleted.
(2) data in the databases according to § 4 paragraph 1 number 2 to 5 are after the last change of the respective record 20 years in the database available. After this period, the data is deleted.

§ 8 right to information is section 19 of the Federal Data Protection Act for legal persons to apply.

articles 9 and 10 (dropped out) Appendix 1 (to § 4 paragraph 1 number 1) general duty of disclosure according to §§ 25 and 30 paragraph 2 MPG general obligation to notify pursuant to sections 25 and 30 MPG (2) medical devices Act (reference: BGBl. I 2014, 1233 - 1238) PDF document is PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window is displayed in its own window PDF document Annex 2 (to § displayed in its own window 4 paragraph 1 number 1) general duty of disclosure according to §§ 25 and 30 paragraph 2 MPG general obligation to notify pursuant to sections 25 and 30 (2) medical devices act, MPG (site: BGBl. I 2014, 1239 - 1243) PDF document is PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window is displayed in its own window PDF document Appendix 3 displayed in its own window (to § 4 paragraph 1 number 2) details of certificates according to § 18 MPG information relating to certificates pursuant to § 18 medical devices act, MPG (reference: BGBl. I 2014, 1244 - 1250) PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window is displayed in its own window PDF document Appendix 4 (§ 4 paragraph 1 number 3) clinical testing/performance assessment test after the articles 20 to 24 MPG clinical investigation/performance evaluation according to § § 20-24 medical devices act, MPG (reference: BGBl. I 2014, 1251 - 1259) PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window PDF document is displayed in its own window PDF document appears in its own window system 5 (§ 4 paragraph 1 number 4) notification to the classification of a medical device or Definition to non-medicine products notice on the classification of a medical device or demarcation from other products (reference: Federal Law Gazette I 2014, 1260 - 1263) PDF document is PDF document is displayed in its own window PDF document is displayed in its own window PDF document appears in its own window displayed in its own window