techUK, in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), is pleased to host an in-person roundtable to explore the MHRA’s evolving compliance strategy. This session will provide an opportunity for members to hear about the extension of the strategy beyond medicines to include medical devices and in vitro diagnostics (IVDs), and to share feedback directly with the MHRA.
This will be a listening and learning session for MHRA colleagues, designed to gather insights from industry on the challenges and opportunities around compliance across the product lifecycle. The discussion will help inform future guidance, transparency measures, and support mechanisms.
Agenda:
10:30 – Welcome and Introductions
10:40 – MHRA Presentation
- Overview of the compliance strategy
- Extension to medical devices and IVDs
- Current status and next steps
10:55 – Open Discussion
Facilitated roundtable covering:
- Key compliance challenges
- Pre-market and post-market considerations
- Navigating the system when entering the UK market
- What support or guidance would be most helpful from MHRA?
- Ideas for improving transparency, feedback loops, and sharing case studies
12:15 – Summary and Next Steps
- Reflections from MHRA
- Opportunities for continued engagement
12:30 – Close
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