What structures are defined for the sharing of product information among the Competent Authorities of the Member States? – EUDAMED
COUNCIL DIRECTIVE 93/42/EEC
1. Regulatory data in accordance with this Directive shall be stored in a European database 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 authorised representatives and devices in accordance with Article 14 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(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures, as laid down in Annexes II to VII;
(c) data obtained in accordance with the vigilance procedure as defined in Article 10;
(d) data relating to clinical investigations referred to in Article 15.
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(d), shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
4. The provisions of this Article shall be implemented no later than 5 September 2012. The Commission shall, no later than 11 October 2012, evaluate the operational functioning and the added value of the databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Council or present draft measures in accordance with paragraph 3.
1. Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.
This does not affect the obligation 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.
2. The following information shall not be treated as confidential:
(a) information on the registration of persons responsible for placing devices on the market in accordance with Article 14;
(b) information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure according to Article 10(3);
(c) information contained in certificates issued, modified, supplemented, suspended or withdrawn.
3. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to determination of the conditions under which other information may be made publicly available, and in particular for Class IIb and Class III devices to any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
Member States shall take appropriate measures to ensure that the competent authorities of the Member States cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.
The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.
Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level.