Device regulation extended to 2024
Author: Simon Jones
Changes to medical device regulation in the UK have been deferred until 2024 after the Medicines and Healthcare products Regulatory Agency (MHRA) issued a 12-month extension to the ‘standstill period.’
Manufacturers and suppliers of optical and ophthalmic equipment, lenses and spectacle frames may continue to use either the CE mark or UKCA mark until 30 June 2024, when the MRHA aims to have new regulations in place.
Ann Blackmore, Optical Suppliers Association regulatory affairs consultant, said: ‘The 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 Medical Device Regulation 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.’