Article 10b F1

United Kingdom

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data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;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.

Data shall be forwarded in a standardised format.

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).

Annotations

Textual amendments

F1: 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).