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January 6, 2026
Approximately 5 minutes
Risk Assessment and Research Activities at BfArM for Medical Devices
Risk Assessment and Research Activities at BfArM for Medical Devices
Core Responsibilities in Risk Assessment
The Federal Institute for Drugs and Medical Devices (BfArM) performs scientific risk assessments on medical devices as part of its market surveillance and vigilance duties under the EU Medical Device Regulation (MDR) and national law (MPDG). This includes evaluating reports of serious incidents, field safety corrective actions, and potential risks identified through post-market data. Assessments help determine whether regulatory measures (e.g., restrictions, recalls) are needed to protect public health. Risk assessment and research - BfArM
Incident Data Analysis and Signal Detection
BfArM systematically analyses national and international vigilance data:
- Reviews serious incident reports submitted via EUDAMED or directly.
- Detects safety signals through trend analysis and epidemiological evaluation.
- Collaborates with manufacturers to clarify root causes and risk mitigation.
This process supports rapid response to emerging device risks and informs EU coordination.
Research Projects and Scientific Studies
BfArM initiates and participates in research to deepen understanding of device safety:
- Epidemiological studies on specific device types or adverse events.
- Methodological research on risk assessment techniques.
- Projects evaluating long-term performance or material biocompatibility.
- Collaboration with academic institutions, EU joint actions, and MDCG subgroups.
Key areas include implant registries, digital health technologies, and high-risk devices.
Cooperation and EU Integration
- BfArM contributes to EU expert groups and MDCG working parties on risk management.
- Participates in joint market surveillance actions and vigilance coordination.
- Shares assessment findings with other competent authorities via EUDAMED and secure channels.
Practical Output and Public Benefit
- Risk assessment results feed into BfArM recommendations, field safety notices, and regulatory decisions.
- Research outcomes are published in reports, scientific papers, or guidance documents.
- These activities enhance evidence-based regulation and patient safety in Germany and the EU.
BfArM's risk assessment and research function bridges post-market surveillance with proactive safety science, ensuring continuous improvement in medical device oversight. Risk assessment and research - BfArM
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