MHRA regulation of medical devices – UK update
The current “standstill period” for medical device regulation in the UK has been extended for 12 months, leaving current regulations in place until July 2024. This means that manufacturers may continue to use either the CE mark or UKCA mark until 30 June 2024. This will provide some relief during a period of uncertainty, and pressure on manufacturers and suppliers.
OSA has been monitoring the situation very closely for the optical community and will continue to do so.
This provides some degree of certainty for manufacturers and suppliers of optical and ophthalmic technology, lenses and spectacle frames in the short to medium term. MRHA aims to have new regulations in place by July 2024.
Ann Blackmore, OSA Regulatory Affairs consultant, added, “MHRA has confirmed that the government’s continuing intention is to put in place transitional arrangements, which would allow devices that are CE marked under the EU MDR to continue to be placed on the UK market for five years from the date of the new UK regulations, so until at least 2029. They aim to publish draft regulations covering transitional arrangements and post market surveillance in spring 2023.”
Concerns about capacity across the Approved Body system – currently four – have been recognised. Six further organisations have applied to become UKABs and are under review.
Full details are available here: