The end of next month marks another important deadline for medical devices and IVDs on the Union market. In case the first unit of a legacy device or Regulation device has been placed on the EU market before 28 May 2026, the deadline to register the devices is 28 November 2026.
28 May or 28 November: which deadline applies to your devices
When a Regulation device is placed on the market after or as of 28 May 2026, the manufacturer has to register this device before the first individual unit is placed on the EU market starting from 28 May 2026.
In case the first unit of a legacy device or Regulation device has been placed on the EU market before 28 May 2026, the manufacturer has to register their device by 28 November 2026.
Legacy and Regulation devices no longer placed on the market from 28 May 2026 do not need to be registered, unless a post-market surveillance or vigilance action occurs.
md_eudamed_tp-leg-reg-devices_enSource: European Commission (2025)
Registration of certificates on EUDAMED
The module for notified bodies and certificates is available for voluntary use since October 2021. Since 28 May 2026, notified bodies have to register any new MDR or IVDR certificate issued from this date. For any certificate issued before 28 May 2026, the deadline to register them is 28 May 2027. md_eudamed_tp-cert_en
Source: European Commission (2025)
Contact MDlaw for assistance with EUDAMED registrations: here or at mdlaw@obelis.net.
References:
European Commission (2025). EUDAMED. Overview. Retrieved on 13/10/2026.
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