Europe and EUDAMED in the German Medical Devices Framework (BfArM)

EU Single Market for Medical Devices

Medical devices benefit from the free movement principle within the EU single market. Once a device complies with Regulation (EU) 2017/745 (MDR) and is CE marked, it can be placed on the market and put into service across all EU Member States, including Germany, without additional national approval requirements. The MDR ensures uniform high standards for safety and performance throughout the Union. Europe and EUDAMED - BfArM

Role of EUDAMED

EUDAMED is the central European database established under the MDR (and IVDR) to enhance transparency, coordination, and traceability of medical devices across the EU:

• It replaces and expands previous national databases.
• Key functions include registration of economic operators and devices, UDI core data, certificates, vigilance reports, clinical investigations, and market surveillance information.
• Mandatory use of EUDAMED modules supports post-market activities and rapid response to safety issues.

Mandatory EUDAMED Modules

As of the current transition phase:

• Actor module: Registration of manufacturers, authorised representatives, importers, and system/procedure pack assemblers (Single Registration Number - SRN required).
• Device module: UDI/Device registration and core data set.
• Certificate module: Notified body certificates and summary of safety and clinical performance (SSCP).
• Vigilance module: Serious incident reporting and field safety corrective actions.
• Clinical investigations module: Registration of investigations under MDR Article 62.
• Market surveillance module: Coordination among competent authorities.

Some modules remain in phased rollout, but core registration and vigilance obligations are increasingly mandatory.

Obligations for German Operators

• Manufacturers must register in EUDAMED and assign UDI before placing devices on the market.
• Authorised representatives and importers must also obtain SRN and upload relevant information.
• Notified bodies designated in Germany (via ZLG/BfArM process) upload certificates to EUDAMED.
• BfArM, as the German competent authority, accesses EUDAMED for vigilance coordination, market surveillance, and reporting to the European Commission.

Practical Benefits and Transition

• EUDAMED improves traceability, allowing quick identification of affected devices in case of incidents.
• It facilitates cross-border cooperation among competent authorities (e.g., BfArM with other EU authorities).
• Transitional provisions allow legacy devices (under MDD/AIMDD) to follow phased EUDAMED obligations.
• BfArM provides guidance on EUDAMED registration, timelines, and links to the EU EUDAMED portal and helpdesk.

This EU-level infrastructure, supported by national authorities like BfArM, strengthens patient safety, market surveillance, and regulatory efficiency across Europe. Europe and EUDAMED - BfArM