A Notified Body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market.
MitoPedia concepts: MitoFit Quality Control System
These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. The European Commission publishes a list of such notified bodies.
Manufacturers are free to choose any notified body that has been legally designated to carry out the conformity assessment procedure.
The competence of the notified body should be subject to verification carried out at regular intervals and following the practice established by the accreditation organisations.
Important Notified Bodies in Austria / Germany:
- PMG, Prüf- und Zertifizierstelle für Medizinprodukte (A-8010 Graz)
- TÜV Süddeutschland (D-80339 München)
- TÜV Rheinland (D-51105 Köln)