BfArM – Federal Institute for Drugs and Medical Devices

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent German higher federal authority and part of the Federal Ministry of Health.

Tasks of the BfArM in the context of medical devices

The tasks of the Federal Institute are fixed by the Device Law Implementation Act (Medizinprodukte-Durchführungsgesetz, MPDG) and ordinances such as the Medical Devices User Notification and Information Ordinance (Medizinprodukte-Anwendermelde- und Informationsverordnung, MPAIMV).

• The Federal Institute publishes, among other things, reports from manufacturers on the risks of their medical devices.
• It evaluates these reports and occasionally issues recommendations.
• In addition to the ethics committees, the higher federal authority is responsible for approving clinical investigations.
• The BfArM operates the DiGA directory and decides on including digital health applications in this directory.
• In the case of disputes between manufacturers and notified bodies, the higher federal authority also decides on the classification of medical devices.

Searching the BfArM notifications

The notifications published by the authority are not always easy to search. This is also because no full-text search is available, and manufacturers sometimes even upload scanned documents (images embedded in PDFs).