RAPS Euro Convergence 2025 brought together the brightest minds in global regulatory affairs, and once again, Qserve Group was proud to contribute to this dynamic platform. Across three intense days of workshops, panels, and interactive sessions, our team of experts engaged with regulatory professionals from around the world to exchange strategies, dive deep into EU MDR and IVDR developments, and share real-world best practices.

From pre-conference workshops to packed plenary sessions, Qserve’s participation reflected both the challenges and the exciting evolution of regulatory affairs in the MedTech industry. In this blog, we look back on the highlights from each of our hosted sessions, complete with key takeaways to help you stay informed and ahead in your regulatory strategies.

A Deep Dive into IVDR at the Pre-Conference Workshop

Our story began a day before the main conference officially opened. Kristiane Schmidt hosted the Preconference Workshop: From Concept to Compliance, where she unpacked the regulatory challenges of Clinical Performance Studies under the IVDR. Participants navigated through both EU-wide and country-specific requirements for authorizing these studies.

One of the session’s key takeaways was that while harmonization is on the horizon, national variations still present significant hurdles. Local ethical committee review processes, diverse submission portals, and investigator training requirements add layers of complexity. The advice? Tailor your strategy to the countries involved, consider your available resources, and prepare for the unexpected.

Pictured Above Kristiane Schmidt during the Pre-Conference Workshop

Pictured Above: Kristiane Schmidt during the Pre-Conference Workshop.

Global Strategy in Focus: Startups and Market Priorities

With the conference now in full swing, Kristiane took the stage again to moderate the session “America First – Europe Second?”—a lively discussion on global market access strategies for IVD start-ups.

Among the most compelling moments was the story of Aiosyn, a Dutch start-up that achieved IVDR certification for a Class C software product in under 3.5 years. Their secret? Strategic focus, a dedicated team, and the clever use of consultants for everything from QMS setup to mock audits. This session underlined that success in regulatory navigation is as much about business planning and agility as it is about compliance.

Pictured Above: Kristiane Schmidt during the session.

Kicking Off MDR Conversations

Gert Bos opened the MDR dialogue in the MDR Kick-off Panel, a session that examined how Europe can continue improving the regulatory approval process under the MDR framework. With voices from the EU Commission, a leading Notified Body, and industry stakeholders, the session spotlighted anticipated implementing acts expected later this year. These upcoming legislative updates could significantly ease the burden for innovation-driven companies, including SMEs working on breakthrough or orphan devices.

Gert emphasized that while structural change will take time, action is already underway—and preparation is key.

Pictured Above Gert Bos during the MDR Kick-off Panel

Pictured Above: Gert Bos during the MDR Kick-off Panel.

RA with a Human Touch: Motivation that Matters

Gert also led two Solutions Circle sessions under the theme “Insight in Motivation”, which offered a more personal perspective on regulatory affairs. These intimate discussions showcased powerful personal stories from RA professionals, revealing how their work directly impacts healthcare outcomes. It was a refreshing reminder that regulation isn’t just about documents and deadlines—it’s about people, purpose, and public health.

Pictured Above Gert Bos during one of the Solutions Circles

Pictured Above: Gert Bos during one of the Solutions Circles.

Meanwhile, Keith Morel captured a flurry of regulatory movements under discussion at RAPS. His observations focused on both legislative and non-legislative developments, including:

The expansion of eIFU and reclassification of WET devices
Enhanced structured dialogue between manufacturers and Notified Bodies
New MDCG guidance to support innovation
Emerging concepts around a “Breakthrough Technology” designation in the EU
Structured dialogues, particularly in pre-submission phases, are gaining traction as essential tools to align expectations and smooth the path to approval.

Clinical Data Without Borders

Maria Camara Torres brought a global perspective in the session “Maximizing the Value of Clinical Data for Global Submissions (EU/China)”. She guided attendees through strategies for leveraging clinical evidence across regulatory frameworks, especially between the EU and China.

Practical tips on retrospective justifications for clinical data and a breakdown of differences between MDR and NMPA evaluations offered tangible guidance. With input from SGS, the session highlighted the importance of planning clinical investigations with international scalability in mind from the outset.

Pictured Above Maria Camara Torres during the session

Pictured Above: Maria Camara Torres during the session.

Candid Moments at the Sponsored Presentation

In a packed corner of the exhibition hall, Gert Bos and Robert Paassen hosted a Sponsored Presentation that sparked unexpected contrasts: a full house eager to learn, yet few willing to speak up publicly. The interactive debate format created space for post-session dialogue, where attendees engaged more openly one-on-one. Sometimes, the most impactful conversations happen off the main stage.

Pictured Above Gert Bos and Robert Paassen during the Sponsored Presentation

Pictured Above: Gert Bos and Robert Paassen during the Sponsored Presentation.

FDA in Focus: Unannounced Audits

In another Solutions Circle, Gert and Martin de Bruin explored in two sessions the increasingly real scenario of FDA unannounced audits outside the US. The session emphasized readiness: training staff, conducting mock audits, and having contingency plans. Yet a healthy skepticism was also voiced—how realistic are widespread surprise audits given current FDA staffing levels?

The takeaway: prepare regardless. It’s better to be ready and not need it than to be caught off guard.

Pictured Above Gert Bos and Martin de Bruin during the Solutions Circles 1

Pictured Above Gert Bos and Martin de Bruin during the Solutions Circles 2

Pictured Above: Gert Bos and Martin de Bruin during the Solutions Circles.

IMDRF Codes: Connecting the Dots

Keith returned with a detailed session on IMDRF Adverse Event Codes and their role in complaint handling and risk management. He underscored the importance of consistency, linking complaint analysis, risk tables, PSURs, and clinical data using the same standardized terminology.

A highlight came from Gregory Duby of the Belgian Competent Authority, who shared how they use IMDRF codes in AI model training to flag reports worth investigating. His team’s work, part of the JAMS 2.0 initiative, points to a future where machine learning and human oversight combine to make postmarket surveillance smarter and more scalable.

Pictured Above Keith Morel during the session

Pictured Above: Keith Morel during the session.

Disruptive Innovation: The Human-AI Collaboration

In the Plenary Session on Disruptive Innovation, Gert returned to tackle how AI is transforming regulatory roles. A standout moment came from a student ambassador who offered a fresh perspective on the evolving skillsets needed in regulatory affairs.

The session explored how AI shifts human effort from repetitive tasks to higher-level ethical and strategic oversight. As validation and data integrity become critical, regulators must now balance innovation with responsibility.

Closing with a Global View

Qserve’s final spotlight came with Dennis Sarwin’s session on Global Reliance on the CE Mark. Drawing from both industry and EU Commission perspectives, the discussion focused on how CE certification influences global market access.

With over 100 countries referencing the CE Mark, and initiatives like the IMDRF Reliance Playbook gaining momentum, the CE Mark remains a powerful regulatory asset. But Dennis made it clear: while a CE certificate opens doors, it’s not a universal key. Companies need tailored strategies, local intelligence, and patience to navigate international registrations effectively.

Pictured Above Dennis Sarwin during the Solutions Circles

Pictured Above: Dennis Sarwin during the Solutions Circles.

Final Reflections

RAPS Euro Convergence 2025 was not just a gathering of experts—it was a collective effort to drive meaningful change in medical device regulation. For Qserve, it was a chance to lead, learn, and listen. As regulations evolve and markets shift, our mission remains the same: to help MedTech innovators bring safe, effective devices to patients worldwide.

We thank everyone who joined us in sessions, solutions circles, and spontaneous hallway chats.

RAPS-Team

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