UDI Direct Marking: MDR Class IIa and IIb reusable devices

UDI Direct Marking is now required for MDR CE Marked Class IIa and IIb reusable devices.

This is outlined in the MDR under Article 123(g): “with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to: (i) implantable devices and class III devices from 26 May 2023; (ii) class IIa and class IIb devices from 26 May 2025; (iii)class I devices from 26 May 2027;“

This requirement does not apply to MDD legacy devices.