- Great Britain is set to extend its acceptance of CE-marked medical devices for up to seven more years to avoid Brexit-related disruption.
- The current law prohibits manufacturers from placing CE-marked medical devices on the market in Great Britain from July onward. However, the government plans to introduce legislation that will allow CE marks to be used in the region until 2028 or 2030, depending on the device.
- Officials proposed the new timelines to ensure medical devices remain available in Great Britain while they work to set up a new post-Brexit medtech regulatory regime.
England, Scotland and Wales, collectively known as Great Britain, never adopted the European Union’s Medical Devices Regulation (MDR) because its delayed date of application happened after the end of the Brexit transition period. Northern Ireland, which along with Great Britain makes up the United Kingdom, is subject to MDR under the terms of the Brexit deal.
As such, Great Britain needs its own regulatory regime for medical devices and in vitro diagnostics (IVDs). The government outlined its plans last year, at which time it was targeting a 2023 implementation date for the new regulations. Last year, officials extended the transitional arrangements out to July 2024.
The new plan gives the industry even more time to adapt. Officials are now aiming for “core aspects” of the future regime for medical devices to apply from July 1, 2025. Manufacturers will still be able to sell CE-marked devices in Great Britain for years after that date.
Under legislation that the government plans to introduce soon, CE-marked “general medical devices” that comply with the outgoing EU directives can be sold in Great Britain until June 30, 2028. The transition period for IVDs placed on the market under the outgoing directive, and for all medical devices that comply with MDR, will end on June 30, 2030.
The transition period applies to CE marks granted before Great Britain fully establishes its own medtech regulatory regime in July 2025, according to a statement issued by the Medicines & Healthcare products
Manufacturers with CE marks that expire after that date will need to get certified under the new Great Britain system. The agency said it plans to adopt new, stronger postmarketing requirements in mid-2024.