HPRA have today (23rd March 2026) released their latest update and the Mandatory Use of EUDAMED modules for medical devices.
Mandatory use of the four EUDAMED modules for medical devices begins on 28th May 2026. The modules are:
- Actor registration
- UDI/Device Registration
- Notified bodies and certificates
- Market surveillance
The table below outlines where transition periods are applicable:
What should you do before 28th May 2026?
- Complete registration in the Actor module if you are a manufacturer, authorised representative, importer or a system and procedure pack producer
- Register MDR/IVDR devices placed on the market on or after 28th May. You must register before the first unit is placed on the market (there is no transition period for these devices)
What should you do before 28th November 2026?
- Register legacy devices and MDR/IVDR placed on the market before 28th May.
The update from the HPRA can be found here:
https://www.hpra.ie/news-events/news/article/mandatory-use-of-eudamed-modules-for-medical-devices
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