The Two-Step Process: CE Marking and Mandatory BfArM Registration for German Market Access

German Medical Device Registration: Two Key Regulatory Steps

Accessing the German medical device market requires a dual approach, combining the pan-European compliance of the EU Medical Device Regulation (EU MDR) with mandatory national notification governed by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).

Step 1: Achieving Pan-European Compliance (CE Mark)

The initial, and most critical, step is achieving the CE Marking. This allows the device to be legally placed on the market across the entire EU, including Germany.

• Device Classification: Determine the device class (I, IIa, IIb, III) according to MDR Annex VIII, as this dictates the required conformity assessment route.
• Technical Documentation: Assemble a comprehensive Technical File and Clinical Evaluation Report (CER) to demonstrate safety and performance.
• QMS Certification: Implement a Quality Management System, typically compliant with ISO 13485. For higher-risk classes (IIa, IIb, III), a Notified Body must audit and certify the QMS and the device file.
• EU Authorized Representative (AR): Non-EU manufacturers must appoint an EU AR to act as the legal point of contact within the EU.

Step 2: Mandatory National Registration (BfArM Notification)

Once the CE Mark is secured, national notification must be completed with the German competent authority, the BfArM.

• BfArM Notification: All devices, including self-declared Class I devices, must be notified to the BfArM. This is a crucial step for market surveillance and vigilance management in Germany.
• EUDAMED & National Portals: While the goal is central registration in EUDAMED, Germany maintains a national notification system for certain modules or relies on the BfArM interface to fulfill national oversight requirements during the EUDAMED transition phase.
• Required Information: The notification typically requires details regarding the manufacturer, the AR, the device classification, and the CE certificate (if applicable).

Key German-Specific Requirements

Manufacturers must also adhere to specific requirements enforced at the national level:

• Language: All safety-relevant information, including Labeling, Instructions for Use (IFUs), and safety warnings, must be provided in the German language.
• Vigilance: Serious incidents and Field Safety Corrective Actions (FSCAs) must be promptly reported to the BfArM by the AR.