Is UKCA Marking currently required in order to sell my devices in the UK?
No, UKCA Marking is not currently required. The MHRA allows devices to be marked in the UK leveraging UKCA Marking or CE Marking.
For medical devices and IVDs, the CE Marking cut-off period was initially 30 June 2023. However, the MHRA announced they intend to postpone UKCA Marking compliance until July 2024. As well, the MHRA will offer a longer transitional period for CE Marked devices. That official announcement is available: HERE
This means that the following transition periods apply:
MDR, IVDR, and IVDD CE Marked devices – five (5) year transition period after the new regulation takes effect, i.e., through July 2029
MDD and AIMDD CE Marked devices – three (3) year transition period after the new regulation takes effect, i.e., through July 2027
Devices UKCA Marked under the current regulatory framework will have the following transitional period:
UKCA Marked medical devices – three (3) year transition period after the new regulation takes effect, i.e., through July 2027
UKCA Marked IVDs – five (5) year transition period after the new regulation takes effect, i.e., through July 2029
The caveats outlined for both CE Marked and UKCA Marked devices are as follows:
- “devices that are subject to significant changes in design or intended purpose will be excluded from these provisions”
- “all post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements”
Note that this does not exempt manufacturers from registering their devices with the MHRA, nor does it exempt foreign manufacturers from appointing a UK Responsible Person (UKRP). Whether the device is CE Marked or UKCA Marked, it must be registered before it can be placed onto the UK market. Where applicable, the designated UKRP will complete the registration on the manufacturer’s behalf.
For more information, please read: UK Medical Device Registration, UK Responsible Person