BfArM provides for the market surveillance of medical devices by the competent authorities in Germany an up-to-date and central information system.
Medical devices that are already registered inside the EEA through a European authorized representative do not need an additional registration at MPI and can be sold in Germany! Please, also see § 5 and § 25 MPG (German Medical Devices Act).
For information on how to check the validity of certificates or registrations please visit Service.
The most frequent questions and answers in connection with the coronavirus have been summarized by the European Commission: Guidance on medical devices [...] in the COVID-19 context
Many answers to regulatory questions can be found at Coronavirus SARS-CoV-2 (in German language).
We also publish a list of tests that were firstly placed on the German market and registered according to § 25 MPG (German Medical Devices Law): Corona-Tests (in German language).
In addition, BfArM provides a list of antigen tests for direct pathogen detection based on the German regulation "Coronavirus-Testverordnung – TestV".
Within the medical devices information system (public part) are available: Medical Devices Notifications (MPA), In Vitro Diagnostic Medical Devices Notifications (MPIVDAOE) and address databases with addresses of the persons reporting, of the competent authorities and of the notified bodies.
Related to the European medical device market we are providing you with information regarding the European Databank Eudamed and the Medical Devices Unit of the European Commission. In addition, you will find links to contact addresses, legislative texts, directives, guidelines and harmonized standards.