This Year So Far
EU officially extends the MDR transition period for legacy devices
It is postponed from 26 May 2024 to:
- 31 December 2027- Class IIb implantable and Class III devices
- 31 December 2028 – Class IIb (all other), Class IIa, Class I sterile/measuring and MDD Class I self-certified devices up-classed under the MDR
The extension only applies to MDD/AIMDD legacy devices. Devices new to market are out of luck and must comply with the MDR prior to marketing.
For more information read: MDR Transition Extension Guide
Switzerland and UK follow to accept the MDR transition extension
MHRA announces new UK regulation to be further postponed (now 2025)
The MHRA announces that the new UK Regulation will now have a target date of July 2025. It was originally intended to be released in July 2023, and then July 2024.
The current UK Medical Device Regulation (UK MDR 2002) is based on the old EU Directives: MDD/AIMDD/IVDD. The new regulation would overhaul the current system, adding more robust requirements. Those proposed requirements are to be similar, but not exact, to the EU MDR/IVDR.
Further, the MHRA announced its intention to continue recognizing CE Marked devices for a longer period in Great Britain:
- MDD/AIMDD CE Marked legacy devices – until 30 June 2028 or the CE Certificate expires
- IVDD CE Marked legacy devices – until 30 June 2030 or the CE Certificate expires
- MDR/IVDR CE Marked devices – until 30 June 2030 or the CE Certificate expires