Legacy Devices in EUDAMED: Your Checklist for the 28 November 2026 Deadline

On 28 November 2026, the transition period for registering devices that were already on the EU market ends in EUDAMED. Manufacturers whose EUDAMED legacy device registration is still open have a few weeks left, and some steps take longer than the data entry itself.

This checklist sorts the remaining work into three phases. Where the deadline comes from and how legacy devices differ from Regulation devices is explained in our article on the device registration transition deadline.

In brief

• Devices already on the EU market before 28 May 2026 that you still place on the market after that date must be registered in EUDAMED by 28 November 2026. This applies to legacy devices and to MDR/IVDR devices.
• Devices that are no longer placed on the market after 28 May 2026 do not need to be registered, except in vigilance cases.
• After the deadline, devices that are not registered in EUDAMED may no longer be legally sold in the EU.
• Actor Registration and a Single Registration Number (SRN) are the starting point for any device registration.
• Legacy devices are registered with an EUDAMED DI in place of the Basic UDI-DI and, if they have no UDI-DI, with an EUDAMED ID.
• The EUDAMED deadline does not extend the MDR or IVDR transition periods.

Which devices the 28 November deadline covers

The deadline applies to devices that were already on the EU market before 28 May 2026 and that you continue to place on the market after that date. Two groups fall under it: legacy devices, certified or declared under the old directives (MDD, AIMDD, IVDD), and Regulation devices that already comply with the MDR or IVDR. Devices placed on the market for the first time after 28 May 2026 had to be registered before placement and are not part of this transition.

Devices that were placed on the market before 28 May 2026 but are no longer placed on the market after that date do not need to be registered. The exception is vigilance: if such a device is involved in a vigilance case, it has to be registered. After 28 November 2026, devices that are not registered in EUDAMED may no longer be legally sold in the EU.

The EUDAMED deadline is separate from the MDR and IVDR transition periods. Regulation (EU) 2023/607 and Regulation (EU) 2024/1860 set how long a legacy device may still be placed on the market. Registering a device in EUDAMED does not change those dates.

Phase 1: take stock of your portfolio

• List every device you place on the EU market after 28 May 2026 and mark it as a legacy device or a Regulation device.
• Confirm that your Actor Registration is complete and that you have your SRN.
• Give more than one Local Actor Administrator (LAA) access, so one absence does not stop the work.
• Compare device names with your certificates and EU declarations of conformity; the device name in EUDAMED must match them.
• If you have changed your EU Authorized Representative, check that your device registrations name the new one. The Actor Registration update does not carry over to the device data.

Phase 2: prepare and submit legacy device registration data

Every device you continue to place on the market has to be registered, whether or not a notified body is involved in the registration. A notified body validates the registration for Class III devices, certain Class IIb devices, IVDR Class D devices, Class B and C devices for self-testing or near-patient testing, and Class C devices with an EU technical documentation assessment certificate.

• Legacy devices are registered with an EUDAMED DI and, if they have no UDI-DI, an EUDAMED ID. They do not need confirmation by a notified body.
• Regulation devices keep their Basic UDI-DI and UDI-DI.
• Before you submit, check the fields you cannot change later. Many Basic UDI-DI and UDI-DI fields, such as "Kit: Yes/No", are locked after registration, and a wrong entry can mean discarding the Basic UDI-DI, which is done by discarding all corresponding UDI-DIs.
• Add certificate information only where the device needs it. Selecting "add certificate" without need is a common error, for example with some Class IIb devices.
• Class Is, Im and Ir devices are registered as "Class I", with the special features recorded under device characteristics.
• An eIFU URL is only needed if the instructions for use are provided electronically. It always starts with "https://".
• For larger portfolios, an XML bulk upload or a machine-to-machine (M2M) connection is usually faster than entering each device by hand.

Phase 3: verify in the final days

• Check the status of every registration. Registrations that need notified body validation show "Submitted" until the notified body has acted.
• Tell your importers that they link themselves to you in EUDAMED. You cannot do this step for them.
• Keep one master list of all your devices with their registration dates, and check it regularly for updates as part of your QMS.

If time is running short

Concentrate on the devices you are placing on the market. If you are switching your EU Authorized Representative, start now: when the switch also means a change of competent authority, that authority has to confirm it.

Recap

Conclusion

The remaining weeks are enough for most portfolios. This week, check two things: whether your Actor Registration and SRN are in order, and which devices you still place on the market after 28 May 2026.