We were proud to sponsor and participate in RAPS Euro Convergence 2025. The event took place in the heart of Brussels. There, the regulatory community gathered to discuss the rapidly evolving landscape for medical devices, IVDs, and digital health technologies.
This year’s conference brought together global regulators, industry leaders, and technical experts. Together, they explored how manufacturers can adapt, compete, and comply in the face of accelerating change.
Key Themes That Shaped the Conversation
AI and the Future of Regulation
One major highlight was the in-depth discussion around the EU AI Act. Regulatory frameworks must evolve alongside artificial intelligence in healthcare. Therefore, experts examined how manufacturers can prepare now. They focused on lifecycle expectations, transparency requirements, and risk classification under the proposed legislation.
Tuning MDR and IVDR
With five years of experience behind MDR and IVDR, many experts voiced support for targeted regulatory “tweaks.” However, they were clear that a full overhaul isn’t necessary. From managing notified body capacity to improving consistency in interpretation, the message was consistent. Smart refinement is needed to ensure long-term viability and efficiency.
Global Competitiveness and Adaptation
Another recurring question was: how can European manufacturers remain competitive while aligning with global frameworks like IMDRF and FHIR? The answer lies in several factors. These include digital readiness, harmonization, and partnerships with experienced regulatory solution providers.
Thought Leadership from LexisNexis® Reed Tech
We were excited to contribute to the dialogue with our presentation:
“EUDAMED UDI: What You Need to Know to Be Compliant.”
In this session, we shared the latest updates on EUDAMED’s implementation timeline. In addition, we discussed technical file readiness. We also offered practical tips on avoiding common data quality pitfalls during UDI preparation.
Missed our session?
A key question echoed throughout the event: how can European manufacturers remain competitive while aligning with global frameworks like IMDRF and FHIR? The answer lies in digital readiness, harmonization, and partnerships with experienced regulatory solution providers.
EUDAMED UDI: What You Need to Know to Be Compliant with Gary Saner, Senior Regulatory Principal, Life Sciences.
Contact us today for the presentation recording or to learn how Reed Tech can support your team with structured submissions, digital labeling, and UDI readiness across global markets.