Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 5, 2026
Approximately 5 minutes
Clinical Investigations and Performance Studies for Medical Devices in Germany (BfArM)
Clinical Investigations and Performance Studies for Medical Devices in Germany (BfArM)
Regulatory Framework
Clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices (IVDs) in Germany are governed by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), supplemented by national provisions in the Medical Devices Implementation Act (MPDG). BfArM is the competent higher federal authority for authorisation of most clinical investigations (except certain IVDs handled by the Paul-Ehrlich-Institut). Clinical investigations and performance studies - BfArM
Clinical Investigations of Medical Devices (MDR)
Authorisation Requirement
- Investigations involving high-risk devices (Class IIb implantable, Class III) or posing specific risks require BfArM authorisation.
- Lower-risk investigations may proceed with notification only, subject to ethics committee opinion.
- Sponsor submits application including investigation plan, risk-benefit analysis, investigator brochure, and ethics committee favourable opinion.
Ethics Committee Involvement
- Positive opinion from an independent ethics committee is mandatory.
- Ethics committees assess ethical aspects, participant protection, informed consent, and scientific quality.
- For multicentre studies, a lead ethics committee coordinates.
Timeline and Procedure
- BfArM decision within 30 days (extendable to 60 days for additional information).
- Substantial modifications require separate authorisation.
- Serious adverse events and deviations must be reported promptly.
Performance Studies of IVDs (IVDR)
Authorisation and Notification
- High-risk performance studies (e.g., involving companion diagnostics or high individual risk) require BfArM authorisation (or PEI for certain IVDs).
- Other studies require notification to BfArM.
- Application includes performance study plan, risk assessment, and ethics committee opinion.
Ethics Committee Role
- Ethics committee favourable opinion required for studies involving human samples or data.
- Assessment focuses on ethical compliance, data protection, and participant rights.
Reporting Obligations
- Sponsors report serious incidents, safety issues, and study progress via EUDAMED or national channels.
- BfArM coordinates vigilance for performance studies.
Sponsor and Investigator Responsibilities
- Sponsors ensure GCP compliance, insurance, and data integrity.
- Investigators conduct study per approved plan and report to sponsor.
- Informed consent and participant protection are mandatory.
Practical Guidance
- BfArM provides application forms, checklists, guidance documents, and FAQs.
- EUDAMED registration required for certain studies.
- Transitional rules apply for legacy studies under MDD/IVDD.
This framework balances scientific advancement with high ethical and safety standards for clinical research in Germany. Clinical investigations and performance studies - BfArM
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Competent Authorities and Ethics Committees for Medical Devices in Germany (BfArM)
The BfArM page describes the roles of competent authorities and ethics committees in Germany under the EU MDR framework, with BfArM as the higher federal authority for market surveillance and vigilance of most medical devices, state authorities handling inspections, and ethics committees responsible for reviewing clinical investigations involving human subjects to ensure ethical standards and participant protection.
Approximately 5 minutes
Europe and EUDAMED in the German Medical Devices Framework (BfArM)
The BfArM explains Germany's integration into the EU medical devices regulatory system under the MDR, highlighting the role of the European database EUDAMED for registration, traceability, vigilance, and market surveillance, with mandatory modules supporting economic operators, competent authorities, and notified bodies across the EU single market.
Approximately 5 minutes
Risk Assessment and Research Activities at BfArM for Medical Devices
BfArM conducts scientific risk assessments, research projects, and data analysis on medical devices to support regulatory decisions, market surveillance, and public health protection, including evaluation of incident reports, epidemiological studies, and collaboration with EU networks.
Approximately 5 minutes
Differentiation and Classification of Medical Devices in Germany (BfArM)
BfArM provides guidance on distinguishing medical devices from other product categories (e.g., medicinal products, biocides, cosmetics) and applying the risk-based classification rules under EU MDR Annex VIII, including consultation procedures for borderline cases to ensure correct regulatory pathway and conformity assessment.