RAPS Regulatory Convergence 2025: Our Thoughts

Ken Pilgrim and Evangeline Loh

We always return from RAPS Regulatory Convergence rejuvenated by the discussions, meetings and reminders of regulatory developments.

RAPS plenary sessions

It is clear that regulatory professionals love science, data and facilitating ease to market. A recurring theme, however, is the misalignment between how regulators communicate with the public and how medical practitioners perceive the development and oversight of medical products.

Regulatory requirements, of course, exist to protect patients and users. Practically, if manufacturers are able to provide concise Instructions for Use (or perhaps even summaries, and this does not refer to the European Summary of Safety and Clinical Performance (SSCP), that would benefit the patient and healthcare provider. Medical practitioners continue to be at the forefront of identifying novel concepts for medical devices (and now they can easily fabricate prototypes as well (e.g., 3D print)).

RAPS educational sessions

The sessions featured interesting topics and speakers. A large number revolved around Europe and the continual evolution of the European Medical Devices Regulation (MDR), In Vitro Diagnostic Devices Regulation (IVDR) and artificial intelligence (AI) Act. A European Commission representative was unable to join, though it is clear that all are eagerly anticipating the proposed revised legislation. Manufacturers need to be able to access and then capitalize on structured dialogues: not necessarily useful before a manufacturer has engaged a notified body.

Consider using computer-based modeling and simulation (in silico) tools as part of your medical device testing program to the extent possible.  

RAPS exhibit hall

The majority of exhibitors advanced software, AI tools and services. Presentations abounded on the use of these to advance our collective regulatory genius. Emergo by UL presented a well-attended session on global changes and global change management. Read our next Regulatory Insight for a synopsis of our session.

Thank you for attending our presentation or visiting the Emergo by UL booth. We genuinely enjoyed your visit and hope there are future opportunities to collaborate.

Concluding remarks

We remain more committed than ever to helping you navigate global medical device success.