Deadline Confirmation Background
The European Commission's confirmation of 26 September 2026 as the mandatory EUDAMED UDI database submission deadline for Class III and Class IIb implantable devices follows the final extension granted in December 2025. Earlier in the EUDAMED rollout, the Commission had granted two previous extensions — in 2022 and 2024 — citing system readiness issues and notified body capacity constraints. The September 2026 deadline has been confirmed as final with no further extension expected.
Scope of the Mandate
From 26 September 2026, manufacturers placing Class III devices or Class IIb implantable devices on the EU market must register their Basic UDI-DI and all associated UDI-DIs in EUDAMED before affixing the UDI carrier to the device label. Existing registrations must be completed by the same date for all in-market devices in these classes.
Class IIa and Class I Extension
Class IIa active devices will become subject to mandatory EUDAMED UDI submission on 26 September 2027, and Class I devices on 26 September 2028, in line with the phased implementation schedule. The Commission confirmed these subsequent deadlines are also final and noted that EUDAMED system capacity has been significantly upgraded since the 2024 extension.
Penalties for Non-Compliance
Member State competent authorities have been advised that market surveillance action, including import holds and corrective actions against distributors stocking non-EUDAMED-registered devices, may commence from 27 September 2026. The Commission has published a FAQ addressing common edge cases including transitional stock, parallel imports, and legacy device exemptions.