The middle of autumn is always a time for action, conferences, and other fun. Last week was not unexpected, but it was a packed and fun week.
The start of the week marked the program committee for the RAPS Euro Convergence conference live meeting in Barcelona, in which the program was built out of close to 400 submissions. The preliminary schedules and the selected sessions are promising events in May 2025 in Brussels. If you still need to mark the dates in your calendar, you should do so on 13-16 May.
While the Barcelona RAPS event continued into an interactive mini-conference, the Irish MedTech conference "Global Access" started in parallel. It is a great multi-day event with only panel sessions on key topics of market access, staff development, DEI, and more. Every time a super event happens, the interaction between stakeholders, delegates, and speakers is sublime.
Gert Bos (second from the left) during the Panel ''Navigating the Horizontal Regulatory Matrix''.
A core element of the week, also featured in some of the sessions in Ireland, was the vote in the European Parliament on the proposal to fast-track the implementation of EU MDR and EU IVDR and initiate regulatory reform in the mid-and long term. Whereas at first glance, it might appear that the focus of the running and prepped conferences collides with the forward-looking proposals from the EU Parliament, this might actually not be the case, and both might well enhance each other!
The current conferences focus on the efficient implementation of the EU MDR / IVDR, as well as successes and strategies to overcome some of the current challenges in implementation. Overall, achieving regulatory compliance is feasible for the selected products and product families undergoing conformity assessment procedures. Stories strengthened that we are much closer to understanding and agreeing on the minimum dataset needed, including the discussion on what constitutes sufficient clinical evidence.
The engagement from the European Parliament emphasizes that we need to continue with the current implementation and, on top of that, should work on improvements. On the one hand, to be clearer and more transparent in process timelines and pricing while removing unnecessary administrative burdens. On the other hand, we should actively seek solutions for those at risk of being left behind in the mainstream push to get products through the assessment process: SMEs, innovative devices, orphan devices, and devices designed for specific patient groups, such as pediatric patients. As witnessed by earlier MDCG guidance and various industries, notified bodies, and parliament position papers, these improvements were already in the making.
If we combine the efforts, we'd see a continued push to complete running and recently initiated conformity assessments, many of which follow the approval of the applications prior to the September 26 deadline. We'd also see an enhanced focus on fixing the currently less favorable elements. Overall, I am quite positive now that completion of phase 1 implementation and fast-track phase 2 improvements are on the agenda for all stakeholders. It's time to make this happen, big time!
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