Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
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1. Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.
The databank shall contain the following:
[F2(a) data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;]
(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures, as laid down in Annexes II to VII;
(c) data obtained in accordance with the vigilance procedure as defined in Article 10;
[F3(d) data relating to clinical investigations referred to in Article 15.]
2. Data shall be forwarded in a standardised format.
[F23. The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).]
[F34. The provisions of this Article shall be implemented no later than 5 September 2012 . The Commission shall, no later than 11 October 2012 , evaluate the operational functioning and the added value of the databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Council or present draft measures in accordance with paragraph 3.] ]
Textual Amendments
F1 Inserted by Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
F2 Substituted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).
F3 Inserted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).
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