The Medicines and Healthcare products Regulatory Agency (MHRA) has set out proposals to modernise the Great Britain medical devices regime with the twin aims of (i) improving patient access to high-quality technologies and (ii) supporting growth in the UK’s med-tech sector. The proposals respond to last year’s consultation on future routes to market and signal a shift towards internationally aligned, risk-proportionate regulation with a clearer domestic focus on first-in-market innovation, including AI as a medical device.
In this article we set out the proposed changes, how these could affect Great Britain manufacturers and providers, and advise practical next steps for businesses in the healthcare sector.
At the heart of the package is the introduction of international 'reliance' routes that would enable certain devices already authorised by trusted regulators in Australia, Canada and the United States to follow a streamlined pathway onto the Great Britain market. Alongside this, the government intends to consult later this year on the indefinite recognition of ‘CE-marked’ devices, moving beyond the current transitional arrangements that expire in 2028/2030 depending on device class and underlying EU legislation.
The MHRA also proposes to remove the requirement for a physical UK Conformity Assessed (UKCA) mark on products and packaging once unique device identification is in place. This would allow traceability and post-market surveillance to be delivered through a digital identifier rather than repeated label changes, lowering barriers to entry and ongoing compliance costs.
For in vitro diagnostics, the proposals introduce a more proportionate approach for class B in vitro diagnostics, allowing manufacturers to self-declare conformity where they maintain an ISO 13485-compliant quality management system. This is intended to improve time-to-market for lower-risk diagnostics while preserving appropriate controls.
For manufacturers, reliance routes and potential indefinite CE recognition promise meaningful reductions in duplicative assessments, re-labelling exercises and portfolio fragmentation between Great Britain and other markets. That simplification should translate into shorter lead times for introducing established technologies to Great Britain patients and a clearer investment case for maintaining product lines in a relatively small market.
For providers and supply chains, the proposals are aimed at improving continuity and choice, particularly where devices already in routine use across the EU and North America face friction on entry to Great Britain. The refocusing of the UKCA pathway on novel, first-in-class technologies (including AI-enabled devices) is likely to channel the MHRA’s resources where domestic scrutiny adds genuine value – supporting earlier access while maintaining safety.
Manufacturers should now map product portfolios against the anticipated pathways:
Providers and procurement teams should consider the potential for broader supplier participation and earlier access to specific device categories, particularly software and implantables, and review contract terms that reference labelling or marking requirements to ensure they remain future-proof as unique device identification is implemented.
The MHRA will set out further detail in a pre-market statutory instrument and consult on the proposed indefinite recognition of CE marking later this year. Stakeholders across the ecosystem - including manufacturers, providers, notified bodies and patient groups will want to engage with the consultation, particularly on the scope and safeguards for reliance routes and the operational timelines for unique device identification.
Please contact our commercial team and healthcare sector for tailored advice on navigating these complex issues.
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