Article 12 European databank

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 registration of manufacturers and devices in accordance with Article 10;

(b)

data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedure as laid down in Annexes III to VII;

(c)

data obtained in accordance with the vigilance procedure as defined in Article 11.

Data shall be forwarded in a standardised format.

F13.

The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).

Annotations

Textual amendments

F1: Substituted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Four.