EUDAMED

What it is:

The European Database on Medical Devices (EUDAMED) is the European Commission’s platform designed to improve oversight, traceability, and transparency for medical devices and diagnostics under the MDR and IVDR.

Who is affected:

• All manufacturers and authorized representatives of medical and IVD devices in the EU.
• Importers and distributors responsible for market access.
• Notified bodies and competent authorities managing conformity assessments.

What it requires:

EUDAMED is built on six modules: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, Clinical Investigations, Vigilance, and Market Surveillance. Once fully operational (expected 2027), registration in EUDAMED will be mandatory for market placement.

On osapeers, members exchange knowledge on:

• Preparing data structures for EUDAMED submissions.
• Ensuring alignment with global UDI standards and GDSN.
• Managing updates across internal systems to maintain regulatory readiness.