S.L. 427.44 Art. 12European databank.

(1) Regulatory data in accordance with these regulations shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to these regulations on a well-informed basis. The databank shall contain the following:

(a) data relating to registration of manufacturers and authorised representatives and devices in accordance with regulation 11(1) to (3), excluding data related to custom-made devices;

(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures, as laid down in Schedules II to VII;

(c) data obtained in accordance with the vigilance procedure as defined in regulations 10(3) and (5);

(d) data relating to clinical investigations referred to in regulation 9(1) to (8).

(2) Data shall be forwarded in a standardised format by the Medicines Authority.

(3) The provisions of sub-regulations (1) and (2) shall be implemented not later than 5th September 2012.