Registering Medical Devices with the BfArM: The National Notification Requirement

BfArM Notification: Germany's Mandatory Medical Device Registration

In Germany, the primary authority for medical device oversight is the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). While compliance with the EU Medical Device Regulation (EU MDR) and obtaining the CE Mark grants access to the European market, Germany imposes a mandatory national step: BfArM Notification.

1. The Role of the BfArM

The BfArM serves as the national competent authority responsible for:

• Market Surveillance: Monitoring devices placed on the German market to ensure they meet safety and performance standards.
• Vigilance: Receiving and processing reports of serious incidents and Field Safety Corrective Actions (FSCAs) from manufacturers and the EU Authorized Representative (AR).
• National Registration: Maintaining the national register of medical devices until the central European database, EUDAMED, is fully operational and used uniformly.

2. Mandatory National Registration Steps

All manufacturers, including German ones, must notify the BfArM upon placing a device on the German market.

• Eligibility: The device must already have a valid CE Mark based on a Declaration of Conformity (Class I) or an EU Certificate (higher classes).
• Notification Requirement: Manufacturers must provide specific data to the BfArM, including the manufacturer's details, the device classification, and the details of the EU Authorized Representative (for non-EU companies). This notification must be made before the device is first distributed in Germany.
• Language Compliance: All user-facing documentation, most notably the Instructions for Use (IFU) and labeling, must be provided in the German language as part of national requirements for patient safety.

3. Vigilance and Post-Market Obligations

The AR plays a crucial role in maintaining German compliance post-market.

• Reporting: The AR must ensure that all serious adverse events occurring within Germany are reported promptly to the BfArM.
• PMS Maintenance: Ongoing adherence to the device’s Post-Market Surveillance (PMS) plan and submission of Periodic Safety Update Reports (PSURs) ensure the device's long-term safety profile is monitored and communicated to the German authority.