Because 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, it needs its own regulatory regime for medical devices and in vitro diagnostics (IVDs).
The government outlined its plans last year, and extended the transitional arrangements out to July 2024. Under new plans, ‘core aspects’ of the future regime for medical devices will apply from July 1, 2025, although 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.
Manufacturers with CE marks that expire after that date will need to get certified under the new Great Britain system.
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