Within the framework of the notification, reporting and conformity assessment procedures for medical devices and in vitro diagnostic medical devices, various federal higher and federal state authorities as well as other institutions must be involved in accordance with the Medical Device Law Implementation Act (MPDG) in Germany.

On the following pages the address and contact information of the respective authorities in Germany and the EEA Member States is provided (partly only in German language).
You will find the competent federal state authorities (authorities of the Länder) for the notification of the placing on the market of medical devices at "Landesbehörden Inverkehrbringen". The authorities of the Länder for applications regarding clinical investigations or performance studies are listed at "Landesbehörden Klinische Prüfungen".

The ethics committees with competencies for medicinal products are listed at Arzneimittel - Ethik-Kommissionen.

More institutions in the European Economic Area (EEA)

For manufacturers and their authorised representatives who wish to notify their products in other EEA Member States, the Directorate-General for Health and Food Safety at the European Commission provides a list with address and contact details of the competent institutions.

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. Overview of the notified bodies: Notified Bodies