Germany's Unique Regulatory Landscape: National Requirements Beyond EU MDR

German-Specific Requirements for Medical Device Market Entry

While Germany is part of the European Union and adheres to the EU Medical Device Regulation (EU MDR), it maintains distinct national requirements that create a more complex regulatory environment than in many other member states. Manufacturers must fulfill both EU and national obligations for successful market access.

1. Mandatory National Notification

Beyond the pan-European registration in EUDAMED, Germany enforces its own national notification requirements:

• BfArM Notification: All medical devices, including self-declared Class I devices, must be notified to the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), the Federal Institute for Drugs and Medical Devices. This step is crucial for national market surveillance and vigilance management.
• National Oversight: The BfArM interprets and enforces EU regulations with specific national standards, requiring manufacturers to satisfy enhanced scrutiny on documentation and post-market activities.

2. Strict Language and Documentation Requirements

Germany maintains one of the strictest language mandates in the EU:

• German Language Requirement: All patient-facing and safety-relevant documentation, including the Instructions for Use (IFU), labeling, and safety warnings, must be provided in the German language. This is a mandatory requirement for device placement on the German market.
• Enhanced Documentation Standards: German authorities emphasize the completeness and quality of technical files. Manufacturers often face higher expectations for their Clinical Evaluation Reports (CERs) and Risk Management Files, particularly for higher-risk devices (Class IIb and III).

3. Authorized Representative and Post-Market Obligations

For manufacturers outside the EU, compliance heavily relies on the designated EU Authorized Representative (AR).

• AR Role: The AR serves as the legal liaison between the manufacturer and the BfArM, managing all formal regulatory communication, including mandatory national notifications.
• Vigilance and Surveillance: Manufacturers must have robust systems in place for Post-Market Surveillance (PMS) and prompt Vigilance Reporting (serious incidents and corrective actions) to the BfArM through their AR.