Article 12European databank

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data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedure as laid down in Annexes III to VII;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

2.

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).