“By modernising our approach, we can help ensure patients benefit from safe, effective innovations sooner”

James Pound is Executive Director, Innovation and Compliance at the Medicines & Healthcare products Regulatory Agency (MHRA). The MTG asked him to give us an update on this pivotal year for regulatory reform and innovation.

The MHRA’s regulatory reform programme is now well underway. Can you give us an overview of where you are in that journey and how the new framework connects to the ambitions of the 10 Year Health Plan?

The MedTech regulatory reform programme is advancing against the published roadmap. Over the past several years the MHRA has been building a framework that is more agile, more proportionate to risk, and better able to support innovation, while maintaining high standards of patient safety.

Last year the post-market surveillance regulations were introduced for manufacturers, strengthening requirements around monitoring and reporting, which provides us with more safety information on medical devices in use in Great Britain, allowing the MHRA to act quickly when needed to reduce potential harm. That reflects a clear shift towards more active, lifecycle-based regulation, where evidence gathered after devices reach the market plays a much stronger role in protecting patients.

The next phase of the programme will see the introduction of a pre‑market statutory instrument (SI) to modernise the requirements that apply before a medical device is placed on the Great Britain market. Key measures include:

  • An international reliance scheme to provide swifter routes to market for certain medical devices and in vitro diagnostic devices (IVDs) already approved in Australia, Canada, and the USA.
  • Updated device classification rules to ensure more risk‑proportionate regulation and align with international rules.
  • Strengthened essential safety and performance requirements in line with international practice.
  • Mandated use of Unique Device Identifiers (UDI) for medical devices and IVDs and implant cards for implantable devices, improving traceability and patient information.
  • Rules to prevent misleading or unsubstantiated claims about medical devices.
  • Enhanced technical documentation requirements so there are clear records.
  • More flexibility for the situations where electronic instructions can be used.

These amendments are designed to improve access to medical devices, enhance alignment with international best practice whilst strengthening patient safety.

In terms of the immediate next steps, the MHRA will shortly notify the SI to the World Trade Organization (WTO) for 60 days. Once that process is complete, the SI will move through the parliamentary process.

This progress aligns closely with the ambitions of the 10 Year Health Plan for England. The Plan is about improving outcomes, enabling earlier diagnosis and intervention, and making smarter use of innovation and technology across the NHS. Effective regulation is a critical enabler of that ambition. By modernising our approach, drawing on international evidence, strengthening post market oversight, and creating clearer routes for novel technologies, we can help ensure patients benefit from safe, effective innovations sooner, while giving industry the confidence and clarity it needs to invest in the UK.

With CE recognition now proposed to continue indefinitely, the UKCA route is increasingly being positioned as the pathway for novel, first-in-market technologies. How do you see that route serving innovative medtech companies, and what support is the MHRA putting in place for those going through it?

The MHRA recently consulted on the indefinite recognition of CE marked medical devices in Great Britain. The outcome of that consultation will be published as soon as it is ready. If taken forward by the government, this measure will provide stability and continuity for the vast majority of devices on the Great Britain market, which is important for patients, the health system, and industry.

At the same time, the UKCA route to market gives the opportunity to offer something distinctive for innovators, particularly for innovators of technologies that are genuinely new or first-in-market, such as AI medical devices or new genomic technologies. Work is ongoing to develop this offer, taking input from the National Commission into the Regulation of AI in Healthcare which will publish a report to advise the MHRA on a future regulatory framework for health AI this summer.

The MHRA is also developing an Early Access Service this year. The service will offer conditional market access for innovative devices that address clearly defined unmet clinical needs from the NHS or that have the potential to significantly improve patient outcomes. The Early Access Service would offer a stage for innovative medical technologies to gain access for patients and the public prior to obtaining a UKCA mark.

The international reliance routes from the US, Australia and Canada are a significant new option for manufacturers. How do you see these routes working in practice, and what uptake are you expecting?

These routes will offer manufacturers a streamlined pathway which focuses on specific requirements due to relying on the previous assessments performed by the US FDA, Australian TGA or Health Canada.

We expect the routes to benefit Small and Medium Enterprises (SMEs) as well as multinational companies, attracting companies to place their devices on the market in Great Britain and gather more clinical data whilst they are in the queue for other approvals.

While uptake cannot be predicted with certainty, regulatory authorities such as ANVISA, who have recently implemented a reliance mechanism for products which are registered with regulators within Medical Device Single Audit Program (MDSAP), have reported that applications submitted via these routes have accounted for approximately 14% of total within the first two years.

You’ve indicated that the new early access service will initially focus on dementia diagnostics. What would success look like in year one, and what conditions would need to be in place to expand it into other areas?

Success in the first year of the early access service for dementia diagnostics would be demonstrated by quicker access to innovative diagnostics for patients, directly supporting the Dementia Mission’s target that 92% of patients referred for dementia assessment receive a diagnosis within 18 weeks.

There should be a clear and measurable reduction in the time it takes to bring innovative dementia diagnostic devices for access by patients, alongside strong uptake within clinical pathways so that patients and clinicians experience tangible improvements in diagnostic speed and quality to meet the Dementia Mission target.

A successful first year would also include the generation of robust Post-Market Surveillance data and real-world evidence, ensuring that products entering through the service remain safe and effective while progressing toward full regulatory approval.

To expand the service into other areas, there would need to be evidence that the model delivers clinical effectiveness, demonstrable service efficiency, and earlier patient access; clearly illustrating the value of the early access approach. Expansion to other areas would also require evidence of unmet clinical need, and strong stakeholder engagement, with active participation from clinicians, patient groups, and other relevant parties to foster trust and support.

Image Credit: James Pound headshot via GOV.UK

April 2026

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