Regulation in the medtech sphere: What the future holds for UK compliance and innovation

Last Updated on 04/06/2025 by Sarah Sarsby

At the recent British Healthcare Trades Association (BHTA) and AXREM conference, Dr Rob Reid, Deputy Director of Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA), delivered the first part of a pivotal talk titled ‘Regulation in the Medtech Sphere’.

Titled ‘The Future of MedTech – Innovating for Tomorrow’, the conference was held on 13 May 2025 at The Mercure, Northampton.

Rob’s presentation provided valuable insights into the UK’s evolving regulatory landscape and what medtech companies must prepare for in the coming months and years.

Preparing for a modern regulatory framework

The UK’s current regulatory framework, the Medical Device Regulations (MDR) 2002, is outdated and in need of an update, Rob explained. MHRA’s regulatory update aims to align the UK’s framework with advances in technology, international standards, and recommendations from the Cumberlege review.

Central to the reform effort are three priorities: public and patient safety, support for innovation and growth, and closer alignment with international regulatory partners.

The MHRA’s updated medical devices regulatory road map, published in December 2024, divides the work into four key blocks: post-market surveillance, pre-market requirements, policy development, and software and AI. Of immediate relevance to the medtech sector is the introduction of new post-market surveillance (PMS) regulations, which come into force on 16 June 2025.

New post-market surveillance regulations

Rob emphasised the critical role of PMS in ensuring safety and enabling faster, yet responsible, market access.

Historically, PMS requirements under UK MDR were set out in guidance rather than legislation, resulting in inconsistent compliance. “We had some companies that were doing a very good job… and others that weren’t,” Rob stated. By introducing PMS into legislation, the MHRA aims to level the playing field and ensure higher safety and performance standards.

The new PMS regulations will apply to all medical devices placed on the market or put into service in Great Britain from 16 June 2025. This includes devices approved via CE marking or the Northern Ireland Protocol, although there are limited exemptions (e.g. for custom-made devices and those used in clinical investigations).

Key features include:

• Risk-based approach: Requirements will vary depending on device classification.
• Tighter reporting timelines: Serious incident reporting deadlines have been shortened from 30 to 15 days.
• More scrutiny: Enhanced oversight by approved bodies and the MHRA.
• Improved guidance: A comprehensive guidance document was published in January 2025 and will be updated based on stakeholder feedback.

Manufacturers must implement a PMS system based on a detailed PMS plan, covering incident reporting, feedback collection, and corrective actions. As Rob noted: “It’s not just safety that matters… post-market surveillance provides the opportunity to monitor performance in the real world.”

Premarket regulation reforms and international reliance

The second priority area is the forthcoming premarket regulations, which are currently being finalised following consultation. These will focus on essential changes, including:

• Introduction of unique device identifiers (UDI) for all devices.
• Alignment with international standards to support global competitiveness.
• Creation of new routes to market via international reliance.

This last point marks a significant shift. The UK will begin recognising approvals from trusted regulators such as Australia, Canada, the EU, and the US, with implementation of international reliance pathways expected from mid-2027. Rob explained: “This will effectively be the long-term response or solution in terms of international reliance.”

These regulatory updates are expected to be laid in Parliament by the end of 2025, subject to legislative scheduling, with some measures entering force by mid-2026.

Looking ahead: AI, innovation, and continuous improvement

The MHRA recognises that regulation must evolve alongside rapid technological advancements. For areas like AI and software, the agency is prioritising agile, guidance-led approaches rather than rigid legislation. Rob highlighted the UK’s international leadership in this area and initiatives like the AI Airlock, a regulatory sandbox designed to help innovators navigate approval pathways.

Additional future enhancements under consideration include policies for early access to devices, sustainability, remanufacturing, and health institution exemptions. The MHRA is also developing a fee-based scientific and regulatory advice service for companies with complex regulatory challenges.

Closing remarks

BHTA members and the wider medtech community were encouraged to engage with the new PMS guidance, prepare for compliance, and stay informed as the MHRA rolls out the next stages of medical device regulatory reform.