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

The ZLG publishes the Notified Bodies on their website according to the EU regulations (MDR and IVDR).

List of Notified Bodies by ZLG

Designating Authority

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