German Medical Device Registration: BfArM and National Requirements

Medical device market access in Germany is governed by the overarching European Union Medical Device Regulation (EU MDR 2017/745) and national legislation enforced by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (Federal Institute for Drugs and Medical Devices). Germany represents a major EU market, making national notification a critical step after obtaining the CE Mark.

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1. Pre-Requisites for Market Placement

Before placing a device on the German market, manufacturers must satisfy all pan-European regulatory requirements:

• CE Marking: The device must bear the CE Mark, certifying its conformity with the EU MDR. For Class I non-sterile/non-measuring devices, this is self-declaration; for all other classes, it requires certification by an EU Notified Body.
• Authorized Representative (AR): Non-EU manufacturers must designate an EU Authorized Representative who is responsible for regulatory liaison, technical file maintenance, and communication with the BfArM on the manufacturer’s behalf.
• QMS Compliance: The manufacturer must maintain a Quality Management System compliant with ISO 13485 standards.

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2. Mandatory BfArM Notification

All devices placed on the German market, regardless of classification, require a mandatory national notification to the BfArM.

• National Database Registration: While the final goal is central registration in EUDAMED, Germany currently requires registration with the BfArM's national system (or through the relevant EUDAMED modules once operational). This notification applies to all device classes, including Class I devices, and must include details of the manufacturer, the AR, and the devices themselves.
• Notification Scope: This process ensures the BfArM has oversight for market surveillance, vigilance, and corrective action implementation.

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3. Language and Post-Market Obligations

Germany enforces strict national language requirements and robust post-market obligations:

• Language Requirements: All safety-critical documentation, including Instructions for Use (IFUs), labeling, and safety notices, must be provided in the German language.
• Vigilance Reporting: The AR is responsible for reporting serious adverse incidents occurring in Germany to the BfArM immediately.
• Post-Market Surveillance (PMS): Manufacturers must maintain a robust PMS system, gathering data on safety and performance, and submitting required Periodic Safety Update Reports (PSURs) as dictated by the EU MDR.