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Competent Authorities

Depending on the location of the medical device manufacturer or its representative, the first placing on the market of a medical device must be notified with the corresponding competent authority. Applications for approval of a clinical investigation (CI) of medical devices or performance evaluations (PE) of in vitro diagnostics must be submitted to the competent authority (BfArM or PEI). The federal state authorities are responsible for the monitoring of all CI/PE, as well as for notification of change and withdrawal for CI/PE that were notified before March 21st, 2010.

Competent Authorities in Germany

Manufacturers and their representatives who are domiciled in Germany, or sponsors for clinical investigations can find the address and contact information of the authorities below:

Competent Authorities in the EEA Member States

Manufacturers and their authorised representatives that would like to register their products in other EEA Member States can obtain a list with address and contact information of the "Competent Authorities" form the Enterprise Directorate-General at the European Commission.