UDI Direct Marking: MDR Class I reusable devices

UDI Direct Marking is now required for MDR CE Marked Class I 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.