ABHI Membership

Juggling a national regulatory agenda with that of global positioning for the UK is going to be a really difficult task.  The UK Government nailed international regulation to the future regulatory mast back in March 2023, so ensuring that the development of sovereign regulation aligns with other global regulatory partners will be critical.   

The International Medical Device Regulators Forum (IMDRF), a collective of 21 Management, Observer and Affiliate regulatory authorities and meets twice-yearly to discuss trends and initiatives that then shape global regulatory practice.  The IMDRF spring meeting hosted by the US FDA in Washington DC demonstrated the global interest in regulatory convergence and recognition by attracting over 1200 in-person and virtual registrants. US FDA’s Jeff Shuren highlighted the importance of continued dialogue to establish reliance and recognition across the product lifecycle as a way of bringing innovative products to patients. 

IMDRF Meetings are an opportunity for Industry and for ABHI as a member of the Global Medical Technology Alliance (GMTA), to engage closely with these global decision makers within governments.  

Convergence of UK regulations to global principles and establishing recognition of other regulatory decisions is critical to ensure the UK is a successful and attractive place to do business through pragmatic and facilitating regulation. Alignment with the global regulatory community supports these key links between UK and the rest of the world.   

Of course, formal presentations are the primary way of learning of new initiatives (slides will be available soon).  But being part of the meeting in Washington has cemented many personal relationships and side conversations that will undoubtedly prove beneficial, both for ABHI and UK plc moving forward.   

The first day, which included both Regulator and Industry presentations and panels, explored both pre- and post-market convergence/recognition, highlighting real life examples of how these principle work in practice.  The second day provided the audience with updates on recent national regulatory changes, not just within the IMDRF ‘Management Committee’, but also the ‘Affiliate Members’ and observers. 

The MHRA, attending as one of the ‘Management Committee’, presented on the recently published ‘Roadmap’ to CA marking.  But there were other key global initiatives to consider; 

Looking at all of these highlights, it was clear that in general, global regulators are all looking at Innovation and ensuring pragmatism for future regulatory schemes.  The themes of ‘convergence and reliance/recognition’ were therefore timely and well considered. 

If there has been one criticism levelled at the IMDRF in the past, it is that Industry has had little opportunity to share its experiences and to cooperate on developing efficient regulatory frameworks of the future.  Having attended both the Berlin and now the Washington meetings, ABHI can report that this observation is being reversed.  The last meeting of day 2, chaired by the US FDA and involving the IMDRF Management Committee and Industry leaders, considered how these interactions should proceed in the future.  MHRA and ABHI are very much part of that process, which is a really positive result towards realising our global ambitions.