# Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC), Article 10b

Extent: E+W+S+N.I.

1. Regulatory data in accordance with this Directive shall be stored in a European databank 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:
(a) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;
(b) data obtained in accordance with the vigilance procedure as defined in Article 8;
(c) data relating to clinical investigations referred to in Article 10.
2. Data shall be forwarded in a standardised format.
3. The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(c), shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).

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Source: https://www.legislation.gov.uk/eudr/1990/385/article/10b (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/article-10b
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.