Quality & complianceOfficial

Estonia reminds firms EUDAMED registration deadline for legacy medical devices falls on 28 November

🇪🇪 Ravimiamet · Thu 12 Nov 2026

Ravimiamet says devices placed on the market before 28 May 2026 and still being supplied must be registered in EUDAMED by 28 November 2026.

Estonia's medicines agency, Ravimiamet, has reminded economic operators that the six-month transitional period for registering medical devices in the European database on medical devices (EUDAMED) ends on 28 November 2026.

The core EUDAMED modules became mandatory on 28 May 2026. For devices whose placing on the market began before that date and which continue to be placed on the market, that triggered the transitional period. Such devices must be registered by the closing date.

Ravimiamet sets out two exceptions. A device placed on the market under the Medical Devices Directive (MDD) need not be registered separately if the same manufacturer has already entered an equivalent device compliant with the Medical Devices Regulation (MDR). That applies only where the device already has valid MDR certificates and all the required documentation. Devices that will no longer be placed on the market from 28 May 2026 also do not need to be registered.

The agency points companies to user guides and training videos for the different modules, available in English on the EUDAMED information centre website. It also highlights a recording of its 7 May 2026 training session on using EUDAMED. The session was aimed mainly at manufacturers, authorised representatives and importers, and covered the modules for registering economic operators and devices.

What it means for your team

  • Inventory all legacy devices still being placed on the market that were first supplied before 28 May 2026 and check whether each is registered in EUDAMED.
  • Check whether the MDD-device exception applies: it requires an equivalent MDR-compliant device already entered by the same manufacturer, valid MDR certificates and complete documentation.
  • Confirm which devices are no longer placed on the market since 28 May 2026, as these do not need registration.
  • Allow time before 28 November 2026 to complete registrations, as Ravimiamet's reminder warns of non-compliance if the deadline is missed.

Official source: Ravimiamet ↗

Article written by VigiEye from the official source (Ravimiamet). AI-assisted; check the source before acting.

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