The Government has made regulations (The Medical Devices (Amendment) (Great Britain) Regulations 2023) that enable CE marked medical devices to be accepted in Great Britain for defined periods beyond 30 June 2023.
This measure aims to support the ongoing and safe supply of medical devices within Great Britain and facilitate a smooth transition towards a future strengthened regulatory framework for medical devices.
It is the first statutory instrument in a series that are planned to implement the strengthened framework. Next in the series, the MHRA intends to lay a statutory instrument later this year that will put in place enhanced post-market surveillance requirements.
Core aspects of the future framework for medical devices are intended to apply from 1 July 2025. This timeline is subject to ongoing review as the MHRA continues to monitor feedback from external stakeholders, for instance on the capacity of conformity assessment bodies.
The MHRA guidance has been updated to reflect these changes to the acceptance of CE marked medical devices in Great Britain. This includes an infographic of the timelines for acceptance of CE marked medical devices on the GB market, which is available here.
These measures do not affect requirements for placing UKCA marked medical devices on the Great Britain market. The MHRA’s intended position on transitional arrangements for such devices is in Chapter 15 of the response to the consultation on future regulation of medical devices in the UK. The MHRA says it will continue to work with industry, trade associations and the wider medical devices community to support the effective development of the new regime.
