Competent Authorities and Ethics Committees for Medical Devices in Germany (BfArM)

Higher Federal Authority: BfArM

The Federal Institute for Drugs and Medical Devices (BfArM) serves as the higher federal authority for medical devices in Germany under the Medical Devices Implementation Act (MPDG). BfArM is primarily responsible for:

• Coordinating market surveillance activities.
• Managing the national vigilance system for serious incidents and field safety corrective actions.
• Handling notifications and administrative procedures for most medical devices (excluding certain IVDs assigned to the Paul-Ehrlich-Institut).
• Designating and monitoring notified bodies in cooperation with the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).
• Acting as the single point of contact for EU coordination on vigilance and market surveillance. Competent authorities and ethics committees - BfArM

State-Level Competent Authorities

The 16 German federal states (Länder) have designated competent authorities responsible for on-site market surveillance:

• Conducting inspections of manufacturers, importers, distributors, and users.
• Taking initial measures in case of non-compliance or risk.
• Collecting and evaluating vigilance reports at the regional level before forwarding to BfArM.
• Cooperating with BfArM on coordinated enforcement actions.

Ethics Committees for Clinical Investigations

Ethics committees (Ethikkommissionen) play a key role in reviewing clinical investigations involving human subjects under MDR Article 62 and national provisions:

• Independent bodies affiliated with universities, medical associations, or state chambers of physicians.
• Assess the ethical aspects of clinical investigation plans, including participant protection, informed consent, risk-benefit balance, and scientific validity.
• Issue favourable opinions required before clinical investigations can start (in addition to BfArM or PEI authorisation for higher-risk studies).
• There are approximately 50-60 recognised ethics committees in Germany.

Division of Responsibilities in Clinical Investigations

• For most medical device clinical investigations: BfArM authorisation + ethics committee opinion.
• For certain IVDs or investigations involving higher-risk aspects: Paul-Ehrlich-Institut (PEI) authorisation + ethics committee opinion.
• Ethics committees ensure compliance with ethical principles (e.g., Declaration of Helsinki) and national laws.

Practical Implications

• Manufacturers planning clinical investigations must apply to BfArM/PEI and obtain a favourable ethics committee opinion.
• Vigilance reports from users or operators are submitted to the relevant state authority and/or BfArM.
• BfArM provides guidance on authority contacts, application procedures, and links to ethics committee directories.

This structure ensures coordinated oversight, ethical conduct of clinical research, and effective protection of public health in Germany under the EU MDR framework. Competent authorities and ethics committees - BfArM