European databank
Article 12
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data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedure as laid down in Annexes III to VII;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.
3
The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
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.