CE Marked Medical Devices in Great Britain: Timeline Extended

The UK Government has introduced the Medical Devices (Amendment) (Great Britain) Regulations 2023, allowing CE marked medical devices to be accepted in Great Britain beyond June 30, 2023. This extension 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. (full legal text: Timeframe for accepting CE marked medical devices in Great Britain extended – GOV.UK (www.gov.uk)).

The regulations are part of a series, with enhanced post-market surveillance requirements to be implemented later this year. The future framework for medical devices is expected to apply from July 1, 2025, pending ongoing review. The MHRA has updated its guidance and provided an infographic with timelines for acceptance. These measures don’t impact UKCA marked devices. The MHRA continues to collaborate with stakeholders for effective development of the new regime.