Notified Body Mandate?

Notified Body Mandate
What is the regulatory accountability of Notified Bodies?

Council Directive 90/385/EEC
(5 September 2007)

Article 11

1.  Member States shall notify the Commission and the other Member State of the bodies which they have appointed to carry out the procedures referred to in Article 9 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.

The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.

2.  Member States shall apply the minimum criteria, set out in Annex 8, for the designation of bodies. Bodies that satisfy the criteria fixed by the relevant harmonized standards shall be presumed to satisfy the relevant minimum criteria.

When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).

3.  A Member State that has notified a body shall withdraw that notification if it finds that the body no longer meets the criteria referred to in paragraph 2. It shall immediately inform the other Member States and the Commission thereof.

4.  The notified body and the manufacturer or his authorised representative shall fix, by common accord, the time limits for completion of the evaluation and verification operations referred to in Annexes 2 to 5.

5.  The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.

6.  Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or that a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.

In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof.

The Member State shall inform the other Member States and the Commission.

7.  The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with the criteria laid down in Annex 8.