Info Exchange
What structures are defined for the sharing of product information among the Competent Authorities of the Member States? – EUDAMED
DIRECTIVE 98/79/EC
(18 June 2009)
Article 12
European 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(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedure as laid down in Annexes III to VII;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.
3. The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
Article 19
Confidentiality
Without prejudice to national law and practice on medical secrecy, Member States shall ensure that all the parties involved in the application of this Directive are bound to observe confidentiality with regard to information obtained in carrying out their tasks. This does not affect the obligations of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.
Article 20
Cooperation between Member States
Member States shall take appropriate measures to ensure that competent authorities charged with the implementation of this Directive cooperate with each other and convey to each other the information necessary to ensure application in compliance with this Directive.