BfArM - Germany Federal Institute for Drugs and Medical Devices
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM) is the medical device regulatory authority in Germany. Functioning as an independent body within the Federal Ministry of Health, the BfArM deals with the authorization of drugs of medical devices on the basis of the German Medicines Act (Arzneimittelgesetz, AMG), monitors legal trade of narcotics, and evaluates the potential risk posed by medical devices.
The BfArM is divided into 9 departments, the 9th department being exclusively dedicated to medical device oversight. Its main focus is the evaluation of incident reports and the authorization of clinical investigations on medical devices.
A list of EU regulations can be found here on our website
Contact details:
Medical Device Associations in Germany:
- Bundesverband Medizintechnologie (BVMed)
- Bundeszahnarztekammer Arbeitsgemeinschaft der Deutschen Zahnarztekammern eV
- Deutsche Gesellschaft für Telemedizin
- Deutsche Krankenhausgesellschaft
- Fachverband Biomedizinische Technik e.V.
- Kassenärztliche Bundesvereinigung (KBV)
- Spectaris eV
- VDGH Verband der Diagnostica-Industrie eV
- Zentralvereinigung medizin-technischer Fachhändler, Hersteller, Dienstleister und Berater e.V.
Zentralverband Elektrotechnik- und Elektronikindustrie e.V. (ZVEI)
Related services:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR Compliance Consulting for Cosmetic and Aesthetic Products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies