Is EUDAMED mandatory from 28 May 2026?

Yes. From 28 May 2026, the core EUDAMED modules become legally mandatory for medical device and IVD manufacturers operating under MDR and IVDR. Economic operators must register, obtain an SRN, and ensure required device data is uploaded before placing products on the EU market.

Which EUDAMED modules become mandatory in 2026?

Four modules become mandatory: Actor Registration (SRN) UDI and Device Registration Notified Bodies and Certificates Market Surveillance Manufacturers must ensure compliance with the UDI device registration module and maintain accurate economic operator data.

Do legacy devices need to be registered in EUDAMED?

Yes. Legacy devices already placed on the EU market before 28 May 2026 must still be entered into EUDAMED within the transitional deadline. Manufacturers should review their full device portfolio and prepare UDI data in advance to avoid delays.

What happens if a manufacturer does not comply with EUDAMED requirements?

Failure to comply with EUDAMED registration requirements may lead to: Delays in EU market access Regulatory findings during audits Increased scrutiny from Competent Authorities Potential suspension of device placement EUDAMED compliance will form part of MDR and IVDR regulatory inspections.

How should manufacturers prepare for EUDAMED mandatory compliance?

Manufacturers should: Confirm Actor Registration and obtain an SRN Validate UDI and device registration data Align technical documentation with EUDAMED entries Update QMS procedures to include EUDAMED data governance Conduct internal readiness reviews before May 2026 Early preparation reduces operational disruption and regulatory risk.