# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Article 12: European databank

Extent: E+W+S+N.I.

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(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedure as laid down in Annexes III to VII;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

---
Source: https://www.legislation.gov.uk/eudr/1998/79/article/12 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/article-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.