Many answers to regulatory questions can be found at BfArM.
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
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.
We also publish a list of tests that were firstly placed on the German market: Corona-Tests (in German language)
Medical Devices Information System
Extensive information is required for the market surveillance of medical devices in Germany. BfArM has set up an information system for medical devices according to § 33 Medical Devices Act (MPG), which enables internet-based data entry and editing by persons reporting, sponsors and the competent authorities.
The manuals for persons reporting and sponsors (in German) are publicly available on our site.
The manuals for competent institutions are available within the Medical Devices Information System, where other documents such as the training materials are also uploaded. For this you need to be logged in with your username and password.
General Information Medical Devices Information System
Please note, that the entire Medical Devices Information System is in German language.
The following information gives you an overview of the system's structure and operating controls.
Notifications of Medical Devices and In Vitro Diagnostics
The first placing on the market of MD and IVD as well as information regarding the safety officer must be notified with the Medical Devices Information System.
Clinical Investigations and Performance Evaluations
Starting from March 21, 2010, CI and PE must be approved by the competent authority (BfArM or PEI) and approvingly evaluated by an Ethics Committee before they may commence. The application forms for this purpose can be submitted online through the Medical Devices Information System.