Original UKCA Marking DeadlineOriginal UKCA Marking DeadlineOriginal UKCA Marking DeadlineOriginal UKCA Marking Deadline
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UDI Direct Marking: High-Risk
May 11, 2023
Swiss AR Deadline: Class A IVDs
May 11, 2023

Original UKCA Marking Deadline

May 11, 2023

The UK government announced that the new UK legislation and the UKCA Marking deadline of 1 July 2023 would be postponed. The new deadline for the updated UK medical device legislation is sometime in 2025. Further, the MHRA will continue to recognize European CE Marking for an extended transition period: 2028-2030 depending on the type of device.

 

This does not exempt manufacturers from appointing a UK Responsible Person (if non-UK-based) and registering their devices with the MHRA. It simply means the MHRA will accept device registrations based on CE Marking.

 

NOTE: the postponement does not mean companies cannot UKCA Mark until the deadline. Manufacturers may opt to UKCA Mark today if they wish; however, they are not obligated to do so.

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