Article 10b
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data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;
b
data obtained in accordance with the vigilance procedure as defined in Article 8;
c
data relating to clinical investigations referred to in Article 10.
2
Data shall be forwarded in a standardised format.
3
The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(c), shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).
Inserted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).