EUDAMED (European Database on Medical Devices)
The EU's centralized database for medical device information, including UDI registration, certificates, clinical investigations, vigilance reports, and post-market surveillance data. EUDAMED enhances transparency and traceability across the EU medical device market.
EUDAMED is the European Database on Medical Devices, mandated by EU MDR 2017/745. It serves as a single, centralized repository for information about medical devices marketed in the EU, replacing fragmented national databases with a unified platform accessible to regulators, industry, and the public.
EUDAMED modules
The database comprises six modules: Actor Registration (manufacturers, Notified Bodies, authorized representatives), UDI/Device Registration, Certificates and Notified Bodies, Clinical Investigations, Vigilance and Post-Market Surveillance, and Market Surveillance. Each module supports a different aspect of medical device lifecycle management.
Impact on tender responses
Procurement authorities can verify device registrations, certificate status, and safety reports directly in EUDAMED. Tender requirements increasingly reference EUDAMED registration as a mandatory compliance criterion. Suppliers should ensure their EUDAMED profiles are complete and current before responding to EU tenders, as gaps in registration may lead to automatic disqualification.