From tomorrow, 28 May 2026, the use of four key EUDAMED modules becomes mandatory under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). This marks a major deadline in the EU’s regulatory framework for medical devices and IVDs.
What changes from 28 May 2026
The following EUDAMED modules must now be used:
- Actor Registration: actors must be registered by 28 May 2026.
- UDI/Device Registration: devices must be registered 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.
- Notified Bodies & Certificates: for notified bodies.
- Market Surveillance: for competent authorities.
Do you have any questions on how to register on EUDAMED? Contact us here or at mdlaw@obelis.net.
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