End of EU MDR Article 120 transition period — Class III, IIa, and IIb non-implantable legacy devices
Key Date
2028-12-31 — End of EU MDR Article 120 transition period — Class III, IIa, and IIb non-implantable legacy devices
Under Regulation (EU) 2024/1860, the following device classes must complete EU MDR conformity assessment by 31 December 2028 to continue to be placed on the EU market:
- Class III devices (excluding Class IIb implantables covered by the 2027 deadline)
- Class IIa devices
- Class IIb non-implantable devices
- Class I sterile and Class I measuring devices requiring Notified Body involvement
This is the final end-date for MDD/AIMD certificate-based market access. All devices in these classes must hold a valid EU MDR certificate by this date. Notified Body capacity constraints mean manufacturers should not delay initiating their MDR conformity assessment transition.
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