Yesterday the MHRA updated its list of UKCA Approved Bodies.
The list was not updated to add UKCA Approved Bodies. Instead, it was updated to reduce the scope for two UK Approved Bodies. There are currently only three total Approved Bodies designated for medical device and IVD UKCA marking.
Per the MHRA’s update:
“The SGS United Kingdom Limited Medical Devices Scope document has been updated to reflect the removal of code MD 0110 from Approved Body’s designated scope.
The UL International (UK) Ltd In-vitro Diagnostics Medical Devices Scope document has been updated to reflect the removal of Annex VII from Approved Body’s designated scope.”
MD 0110 is for non-active medical devices for ingestion.
Annex VII is for Production Quality Assurance.
The above update, and full list of UK approved bodies, can be found here.
UKCA marking becomes mandatory in Great Britain (England, Scotland, Wales) as of July 1, 2023, for medical devices & IVDs.
While the MHRA currently allows manufacturers to place devices in Great Britain leveraging their CE Marking, that allowance ends on June 30, 2023. Thereafter, UKCA marking must be applied to the device.
Do you intend to keep placing Class I sterile/measuring, Class IIa, Class IIb, Class III/AIMD devices, or IVD self-test, IVD List A, List B devices onto the market after June 30, 2023?
If so, we recommend you reach out to one of the UKCA Approved Bodies now to obtain UKCA marking. The cutoff date is only approximately one year from today, and there is no guarantee that the MHRA will extend the deadline.