Reflections from MEDDEV Day and RAPS European Lifecycle Management Conference 2025
By Marcus Torr, Head of Post Market Surveys
October was a busy but truly inspiring month. I had the opportunity to attend two events which deep dived into the current status and future of the medical device and IVD regulations; MEDDEV Day and the RAPS European Lifecycle Management Conference. Both offered a fantastic chance to connect with peers across the regulatory community, exchange perspectives, and reflect on how we can continue to improve processes that ultimately serve patient safety.
MEDDEV Day – Shifting mindsets
The theme of this year’s MEDDEV Day centred around “shifting mindsets”, setting the tone for a day of open discussion and forward thinking. Things kicked off with a comprehensive overview of regulatory updates across global regions, from Japan and China to the Middle East, Africa, and the EAEU. It was encouraging to see the progress being made, but also a reminder that true harmonisation, both regionally and globally, remains a work in progress. Despite areas of overlap with the European MDR, significant differences remain, and navigating these regulatory landscapes continues to be a complex challenge for manufacturers.
The EU regulatory update session was a particular highlight. Hearing directly from both authorities/Notified Bodies and industry representatives gave a well-rounded view of the challenges and opportunities under the MDR. The conversation struck a good balance between realism and optimism, acknowledging the hurdles, but also spotlighting how closer collaboration can help reduce burden across stakeholders while keeping patient safety front and centre.
I had the privilege of contributing to the final session, which explored clinical data expectations. Alongside peers from across the industry, we discussed how Notified Bodies view these expectations and how Real-World Data (RWD), whether collected through surveys, patient records, or other sources, can play a crucial role in satisfying evidence requirements, even when that data originates outside Europe. The discussions reinforced the importance of a pragmatic yet robust approach to clinical evidence generation, particularly as the global regulatory landscape continues to evolve.
RAPS European Lifecycle Management Conference – From market access to end of life
The RAPS European Lifecycle Management Conference took us on a journey across the entire device lifecycle, exploring how Medical Devices and IVDs are managed from market entry to maturity and, ultimately, discontinuation. I was delighted to present on Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) strategy alongside Wouter Mattheussens and Jeff Vest. Our shared message was simple but crucial, successful lifecycle management is underpinned by proper planning, implementation, and continuous review. When done effectively, these activities not only support compliance but also provide meaningful insights that drive product improvement and patient benefit.
Several other sessions stood out to me during the conference:
Andrew Gibson, PhD, RAC, and Carole Robin delivered an insightful presentation on how AI tools can streamline the Clinical Evaluation process, with the important caveat that a strong human element must remain to ensure critical oversight and sound judgment.
Goran Abdurrahman presented twice on PMS and PMPF activities under the IVDR, clarifying where these processes align with MDR/PMCF and where key differences exist.
Finally, Nebojsa Serafimovic, Erik Vollebregt, Goran Abdurrahman, Robert van Boxtel, and Dr. Jennifer Neff took a creative twist with their session, “cycling into the future” to explore the upcoming MDR revisions and how incremental adjustments could bring greater clarity and guidance.
Looking Ahead
Both events were great reminders of what really drives progress in our field; collaboration, adaptability, and making decisions grounded in solid data. Looking forward, our challenge (and opportunity) lies in how we bring those principles to life; finding smarter ways to harmonise global frameworks, using real-world data more effectively, and continuing to strengthen our approach to lifecycle management.
I found both events a perfect opportunity to see how our community is evolving together, learning from one another, embracing change, and always keeping the patient at the heart of what we do.