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January 19, 2026
Approximately 5 minutes
Safety Research on Medical Devices at BfArM
Safety Research on Medical Devices at BfArM
Research Objectives and Scope
BfArM initiates and participates in scientific research to deepen knowledge on medical device safety and performance. The focus lies on identifying and evaluating potential risks, especially for high-risk devices, to support evidence-based regulatory actions, improve market surveillance, and contribute to patient safety. Key areas include long-term safety of implants, material-related issues, and emerging digital or combination technologies. Safety of medical devices - BfArM
Key Research Areas
High-Risk Implants and Prostheses
- Long-term performance and failure modes of orthopedic implants (e.g., hip/knee prostheses).
- Epidemiological studies on revision rates, adverse events, and patient outcomes.
- Collaboration with implant registries and clinical networks.
Material Biocompatibility and Degradation
- Investigations into wear particles, corrosion, and degradation products from implants.
- Toxicological and immunological effects of leachable substances.
- In vitro and in vivo testing methodologies.
Emerging Technologies and Combination Products
- Safety assessment of software-driven devices, AI/ML components, and connected systems.
- Risks associated with drug-device combinations and advanced therapy products.
- Post-market data analysis for novel technologies.
Methodology and Collaborations
- Epidemiological and Real-World Evidence: Use of registries, claims data, and vigilance reports for signal detection and trend analysis.
- Interdisciplinary Projects: Cooperation with universities, research institutes, notified bodies, and EU partners (e.g., joint actions, MDCG subgroups).
- Scientific Publications: Results are disseminated via peer-reviewed papers, reports, and conferences to inform the scientific community and regulators.
Impact on Regulation and Public Health
Research outcomes directly feed into:
- Risk assessments and regulatory measures (e.g., restrictions, field safety actions).
- Guidance development and standards improvement.
- Enhanced post-market surveillance strategies.
- Contribution to EU-wide harmonization of safety requirements.
Through proactive safety research, BfArM strengthens the scientific basis for medical device oversight in Germany and supports continuous improvement of patient protection across the EU. Safety of medical devices - BfArM
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