Mandatory EUDAMED use is approaching

Mandatory EUDAMED use is approaching

PhaRegistrum · Originally published on 14/04/2026

From 28 May 2026, use of the following modules will be mandatory:

  • Actor registration.
  • Device/UDI registration.
  • Notified bodies and certificates.
  • Market surveillance.

Without economic operator registration, the other modules cannot be used.

Non-compliance may result in marketing restrictions, device recalls and financial penalties.

Now is the time to ensure your organisation is ready.

#PhaRegistrum
#EUDAMED
#MedicalDevices
#MDR
#Compliance
#RegulatoryAffairs

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