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.
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#EUDAMED
#MedicalDevices
#MDR
#Compliance
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