Medical Device Regulation in Germany
Germany is the largest medical device market in Europe and regulates devices under the EU Medical Device Regulation (EU MDR 2017/745). The Federal Institute for Drugs and Medical Devices (BfArM) is the national competent authority. Germany is home to numerous EU notified bodies and has a robust national implementation of EU MDR through the Medical Devices Implementation Act (MPDG).
Recent Regulatory Updates
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New guidance on legal status and classification.
EUDAMED registration mandatory from May 28, 2026.
New HIIS-VZ registry for assistive device interfaces
Sources Tracked by Qalico
Qalico continuously monitors 2 references across guidelines, regulations, and standards for Germany.
Guidelines
Device Classification
Germany follows the EU MDR risk-based classification. Class I devices are low risk (e.g., compression bandages, hospital beds). Class IIa devices are low-moderate risk (e.g., diagnostic ultrasound, powered wheelchairs). Class IIb devices are moderate-high risk (e.g., dialysis machines, surgical lasers). Class III devices are high risk (e.g., drug-eluting coronary stents, cochlear implants). Classification is determined by Annex VIII of EU MDR.
Official classification guidance →Official Regulatory Bodies
Official Guidance Documents
Official BfArM guidance on medical device regulation in Germany, including vigilance, clinical investigations, and regulatory updates.
Information on the German Medical Device Information and Database System for device registration and tracking.
The European database for medical device registration, UDI management, and certificate data.
Standards & Key Principles
Applicable Standards
Key Principles
- Medical devices must bear the CE mark under EU MDR 2017/745 to be placed on the German market.
- The German MPDG provides national implementation rules supplementing EU MDR, including penalties and enforcement mechanisms.
- Notified body involvement is mandatory for devices of Class IIa and above.
- Non-EU manufacturers must appoint an EU-based authorized representative.
- Germany enforces strict post-market surveillance and vigilance requirements through BfArM.
- Clinical evaluations and clinical investigations must comply with both EU MDR and German ethical review requirements.
Pre-Market Requirements
Devices must comply with EU MDR 2017/745 and obtain CE marking. Notified body assessment is required for Class IIa, IIb, and III devices. Germany hosts several major notified bodies including TÜV SÜD, TÜV Rheinland, and DEKRA.
Comprehensive technical documentation per EU MDR Annexes II and III must be maintained, covering design, manufacturing, risk management, preclinical and clinical evidence.
Clinical evaluations per EU MDR Article 61 are mandatory. Clinical investigations in Germany require BfArM authorization and ethics committee approval under the MPDG.
Registration in EUDAMED is required. Additionally, manufacturers may need to fulfill national registration requirements with BfArM's DMIDS system.
Post-Market Requirements
A comprehensive PMS system is required per EU MDR. PSURs are mandatory for Class IIa, IIb, and III devices. PMS plans must be maintained and updated.
Serious incidents must be reported to BfArM within EU MDR timelines. Field safety corrective actions and field safety notices must be coordinated with BfArM.
PMCF studies must be conducted to continuously validate clinical performance and safety. PMCF evaluation reports are integrated into the clinical evaluation report.
German state (Länder) authorities conduct market surveillance and inspections of manufacturers and distributors, coordinated through the ZLG framework.
International Recognition & Reliance
CE-marked devices conforming to EU MDR are freely marketed across all EU/EEA member states.
CE-marked devices from EU member states are recognized under the Swiss-EU MRA with applicable conditions.