EUDAMED Is Now Mandatory for Four Core Modules: What MedTech Compliance Teams Should Check

MedTech companies operating in Europe have entered a new phase of EUDAMED compliance, as the first four modules of the European medical device database became mandatory from 28 May 2026.

The European Commission confirmed that, from this date, use of the first four EUDAMED modules is mandatory: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance. The change follows the transitional period triggered under the updated EUDAMED implementation framework. (Public Health)

For manufacturers, authorised representatives, importers, and other economic operators, this marks an operational shift. EUDAMED is no longer only a voluntary preparation exercise for these modules. Companies now need to ensure that actor data, device identifiers, certificates, and related records are correctly aligned across internal regulatory, quality, and commercial systems.

For Italian MedTech companies and international manufacturers selling into Italy, the immediate challenge is data readiness. EUDAMED records must be complete, consistent, and aligned with existing regulatory documentation. Any gaps in actor registration, UDI/device data, or certificate information may create downstream issues for market access, audits, and transparency workflows.

The practical message for compliance and regulatory teams is clear: EUDAMED readiness is now an active operational requirement, not a future project.