The MHRA released its 155-page Government Response to the ‘Consultation on the future regulation of medical devices in the United Kingdom’.
Section 15 (Transitional Arrangements) proposes delays to UKCA marking:
- UKCA marking will be postponed, i.e., have a longer transition period before it becomes mandatory
- CE marked devices will continue to be allowed onto the market for a longer transition period
The current date for mandatory medical device UKCA marking is 1 July 2023. And the current last date by which CE marked devices can be placed onto the Great Britain market is 30 June 2023.
The MHRA’s postponement of UKCA marking will put the new UKCA marking compliance dates between 2026-2028, depending on the type of device.
NOTE: the current MHRA guidance still states the UKCA marking deadline is 1 July 2023. Therefore, we are still awaiting the official change to be ratified and updated on the MHRA’s website.
UKCA Marked Devices
If a device already has UKCA marking to the current UK regulation, a transition period will allow those products to be placed onto the market until:
- either the certificate expires or
- for three years after the new regulations take effect (in the case of general medical devices) or five years (in the case of IVDs), whichever is sooner
As a refresher, the current UK regulations are based on the old Directives. The MHRA’s new proposed regulation is similar, but not exactly aligned, to the MDR/IVDR.
What is the new compliance date?
The UK government response states that they still plan for the new regulations to come into force in 2023.
If that does occur, then the date by which the UKCA marked device must comply with the new regulation is 2026 for general medical devices and 2028 for IVDs, or the date the certificate expires, whichever comes first.