EUDAMED is operational, but medical device notification in SIDM is still required

EUDAMED is operational, but medical device notification in SIDM is still required

PhaRegistrum · Originally published on 07/07/2026

Since 28 May 2026, four modules of EUDAMED, the European database on medical devices, have been officially operational.

SIDM remains available in an updated version adapted to work with EUDAMED, simplifying processes and avoiding duplicate registrations.

What changes?

  • Medical devices retain their nationally assigned Medical Device Code (CDM).
  • The Portuguese Medical Device Nomenclature (NPDM) will progressively be replaced by the European Medical Device Nomenclature (EMDN).
  • Economic operators must keep their registrations updated and aligned with the new European requirements.

PhaRegistrum supports manufacturers, importers and distributors throughout the transition, helping ensure regulatory compliance and efficient adaptation.

#PhaRegistrum
#EUDAMED
#SIDM
#DispositivosMédicos
#MedicalDevices
#MDR
#Compliance
#RegulatoryAffairs

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