Notified Bodies

Notified Bodies are nationally accredited bodies that examine the conformity evaluation of the production process completed on behalf of the manufacturers and whose correctness is certified according to uniform assessment factors. Manufacturers can refer to a notified body of their choice which has been named because of the relevant procedure and the product category concerned.

The "Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)" is responsible for designation and monitoring of the Notified bodies in Germany.

Notified Bodies in Germany

In accordance with § 15 (4) of the German Medical Devices Act current information on the scope of designations as well as the identification numbers of German Notified Bodies in the area of medical devices are published on the website of ZLG.
List of Notified Bodies by ZLG

Designating Authority

ZLG - Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten
Heinrich-Böll-Ring 10
53119  Bonn
Phone: +49-228-977940
Fax: +49-228-9779444
zlg@zlg.nrw.de
http://www.zlg.de/

Notified Bodies in the EEA Member States

The Enterprise and Industry Directorate-General at the European Commission provides lists of the Notified Bodies in the NANDO (New Approach Notified and Designated Organisations) information system: