Event round-up: MHRA compliance strategy roundtable
The session brought together MHRA officials, industry leaders, and members of techUK’s Health and Social Care programme to discuss regulatory reform, risk-based compliance, and how the MHRA can better support innovators navigating the UK medical device landscape.
Context and strategic importance
The MHRA is developing a risk-proportionate compliance strategy for medical devices, building on its existing approach for medicines. This comes ahead of the anticipated publication of new UK medical device regulations in mid-2024.
The strategy aims to shift the MHRA’s role from enforcement-led to enabling compliance by design, supporting manufacturers to understand and meet regulatory requirements from the outset. It also seeks to prioritise oversight based on risk, focusing resources on high-impact areas such as AI-enabled software and implantable devices.
Strategic pillars and delivery approach
The MHRA’s compliance strategy is underpinned by six key principles:
- Proactive support: Helping manufacturers comply from the start, rather than reacting to non-compliance
- Risk-based oversight: Prioritising high-risk technologies and use cases
- Incentivising good practice: Encouraging compliance through guidance and engagement
- Technology-enabled regulation: Using AI and data to improve surveillance and streamline processes
- Collaborative partnerships: Working with industry to co-develop solutions
- Intelligence-led action: Using data to identify trends and target interventions
The MHRA is also exploring new models such as “restricted certification” and post-market beta testing to enable earlier access to innovative technologies while maintaining patient safety.
Key themes discussed
Participants shared feedback on several priority areas:
- Education and engagement: Industry called for more direct MHRA engagement, especially with SMEs and software developers, to demystify regulatory pathways and provide tailored guidance.
- Classification clarity: Many attendees highlighted confusion around borderline products and software classification. Suggestions included a hotline or AI-powered tool to help determine device status and risk class.
- Clinical investigations: There was strong interest in streamlining clinical study approvals, especially for low-risk software and predictive tools. Attendees noted challenges in applying traditional clinical evidence models to long-term risk prediction technologies.
- Post-market surveillance: New regulations introduced in June 2025 require active post-market plans for CE and UKCA-marked devices. Participants raised concerns about how to meaningfully monitor performance for probabilistic tools and AI-based diagnostics.
- Global alignment: Attendees asked about differences between UK and EU regulations and how international reliance routes might simplify market access.
Opportunities and next steps
The roundtable surfaced several opportunities for MHRA and techUK to collaborate:
- Develop clearer guidance and flowcharts for innovators, especially in software and AI
- Create forums for ongoing engagement, including webinars and working groups
- Explore regulatory innovation pathways, including early access schemes and in silico validation
- Support the development of platforms like DHSC’s MedTechWIM to improve transparency and public confidence in device safety
MHRA committed to incorporating industry feedback into its compliance strategy and continuing dialogue through techUK and other channels.
For further information or to get involved, please contact Rachel Kennedy, Programme Manager, Health and Social Care, [email protected].
Rachel Kennedy
Rachel joined techUK in December 2024, as a Programme Manager in the Health and Social Care team.
