“Standstill” period for medical device regulation extended to July 2024
Acceptance of CE marked devices in Great Britain was previously set to end on 30 June 2023
15 November 2022
The Optical Suppliers Association (OSA) has welcomed a decision to extend current arrangements for medical device regulation to July 2024.
An OSA statement noted that the extension would give “some degree of certainty for manufacturers and suppliers of optical and ophthalmic technology, lenses and spectacle frames in the short to medium term.”
The announcement means that manufacturers can continue to use the CE mark or UKCA mark until 30 June 2024.
The acceptance of CE marked devices in Great Britain was previously scheduled to end on 30 June 2023.
However, the Government has announced that manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023.
Current arrangements will be extended until July 2024, when the Government plans to implement new medical device regulations.
OSA regulatory affairs consultant, Ann Blackmore, highlighted: “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.”