UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published the government’s response to the consultation, that ran from 14 November 2024 to 5 January 2025, on modernising medical devices regulations in Great Britain (GB). The response outlines major reforms designed to streamline access to the UK market and reduce regulatory burdens for manufacturers, while accelerating and reinforcing innovation, particularly in areas such as AI as a medical device.
This new regulatory direction, shaped by feedback from 287 consultation respondents, marks a strategic shift away to a more internationally-aligned, risk-proportionate approach. The aim is to strengthen patient access to cutting-edge technologies while boosting the UK’s med-tech sector.
Key takeaways from the government response
The MHRA’s proposals are centred around four core pillars: international reliance, UKCA marking, in vitro diagnostic devices, and assimilated EU law.
- International Reliance Framework: a new international reliance framework includes four access routes for different device classes and types, and will allow manufacturers to place medical devices on the GB market based on assessments already granted by trusted overseas regulators – such as the EU, American FDA, Health Canada and Australian TGA. In particular, the MHRA is emphasising support for emerging technologies, like AI as a medical device, recognising their potential to transform patient care. These reforms will provide clearer and faster routes to market for such innovations while maintaining robust safety and performance standards.
- Removing UKCA Marking: the government intends to phase out the requirement for UKCA marking – for devices that have been through the UK conformity assessment process – once a Unique Device Identifier (UDI) system is implemented. This will modernise traceability and reduce administrative burdens, with UDI becoming the primary mechanism for market surveillance and post-market compliance.
- Updating IVD Classification and Conformity Routes: the regulation of IVDs will be brought in line with international standards (e.g. EU IVDR, IMDRF), introducing a risk-based system (from Class A to D). Requirements range from self-declaration (Class A), self-declaration plus ISO 13485 certification (Class B), additional sterility checks and full third-party assessment for both Class A and B sterile devices and finally a full 3rdpart assessment for Class C and D devices.
What this means for manufacturers
The UK’s regulatory landscape is evolving to reflect international alignment, proportionality, and innovation support. For manufacturers, the new framework offers several key advantages:
- Faster access to the UK market through trusted international approvals
- Streamlined regulatory processes and reduced administrative burden
- A targeted approach prioritising first-in-market and innovative technologies
- The ability to leverage existing CE or FDA approvals for Great Britain
At the same time, manufacturers must prepare for changing requirements such as UDI implementation, changes in IVD classification, and updates to conformity requirements. Proactive planning and expert guidance will be essential during this transition.
At IMed Consultancy, we help medical device and IVD manufacturers navigate UK and international regulatory requirements. Whether you’re planning for UDI or revisiting your market access strategy, our team is here to support you.
Get in touch to ensure you’re ready for the next phase of UK medical device regulation.
