Out-Law News 1 min. read
05 May 2023, 8:22 am
Medical device manufacturers should put a plan in place for using the new ‘UKCA’ mark on their products – despite new legislation being put forward to allow EU-derived ‘CE’ markings to continue to be relied upon when selling such products in Britain for years to come.
Louise Fullwood of Pinsent Masons, who specialises in life sciences and health regulation, was commenting after the Medicines and Healthcare products Regulatory Agency (MHRA) confirmed that the use of CE markings on medical devices would continue to be accepted in Britain until mid-2028 or mid-2030, depending on the type of device being marketed, subject to parliamentary approval.
The legislative intervention addresses a gap in the certification regime for medical devices to be marketed in Britain that is otherwise due to arise from July this year.
As things stand, the use of CE markings on medical devices intended for the market in Britain would no longer be accepted beyond 30 June 2023 – although this deadline will be pushed back if the new legislation is approved. At the same time, new medical devices regulations that provide for the transition to the new UKCA markings are not expected to apply until 1 July 2025, according to the indicative timeframes for implementation of the new regulatory regime set out by the MHRA on 27 April.
Fullwood said: “The mandating of the UKCA mark for cease of use of CE mark in the UK has been pushed back several times now. Originally the deadline was set for 1 January 2022, then January 2023, July 2023, July 2024 and now it is 30 June 2028, for general medical devices in compliance with the EU’s Medical Devices Directive, or 30 June 2030, for in-vitro medical devices in compliance with the EU’s In Vitro Devices Regulation or general medical devices in compliance with the EU Medical Devices Regulation.”
“On the one hand, this is good news for industry as it provides a period of certainty rather than the continual delays at smaller intervals. However, there is a risk that with deadlines so far away, some organisations may be inclined to leave this as ‘something to do later’ and be caught out when the deadline does arrive – particularly if lots of others think the same way and the bodies who can carry out conformity assessments are overwhelmed by a last-minute rush. Our advice would be not to kick the can too far down the road but get a plan for moving to UKCA certification,” she said.
The new legislation does not impact on the position in Northern Ireland.
28 Oct 2022
05 Jul 2022