UK Proposal to improve medical devices access in Great Britain

On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced a proposal to improve access to medical devices for patients in the Great Britain. The proposal also aims at boosting economic growth in Britain’s med tech sector.

MHRA proposal: UK government reacts to public consultation outcome

The UK government reacted to the results of a consultation conducted between November 2024 and January 2025. The consultation addressed the following areas:

• International reliance
• UKCA marking
• In vitro diagnostic devices
• Assimilated EU law

According to the proposals, manufacturers should face less duplicative regulatory costs and be able to focus on the domestic approvals route (UKCA) on first-in-market innovative technologies. Specifically, the measures being taken are:

• The government intends to open a consultation later this year and on the indefinite recognition of CE-marked medical devices. Currently, CE marking is recognised until 30 June 2028 or 2030 (depending on the device classification and legislation complied with).
• New international reliance routes will allow certain medical devices from foreign frameworks to enter the market in Great Britain. Particularly, the considered international reliance routes are the compliance pathways from Australia, Canada, and the United States.
• The requirement to affix UKCA markings on products and packaging once unique device identification (UDI) requirements are in place will be removed.
• There will be a more risk proportionate approach for Class B IVD devices, requiring manufacturers to self-declare conformity with the UK Medical Devices Regulations and hold ISO 13485 quality management system certification before placing products on the GB market.

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References

Gov.uk (2025). MHRA announces proposals to improve access to world’s best medical devices for patients and to boost economic growth in Britain’s med tech sector. Retrieved 23/07/2025.