RAPS Euro Convergence 2026 brought together regulatory professionals, manufacturers, authorities, notified bodies, and industry leaders from across the MedTech and IVD sectors in Lisbon for several days of insightful discussions on the future of healthcare regulation and on the interpretation and implementation of the current regulatory state-of-the-art.
Qserve was proud to contribute to the conference through multiple presentations, panels, workshops, and interactive discussions covering topics ranging from MDR 2.0 and clinical evidence strategies to Real-World Data, IVDR performance studies, UK MDR developments, and biological evaluation.
The conference opened with a pre-conference workshop led by Kristiane Schmidt, Building Global CDx Studies: Strategic Planning Tools for IVD and Pharma Partners. The session explored the growing complexity of combined pharma and companion diagnostic studies across Europe. Through practical case studies and interactive discussions, participants examined multi-country submission strategies, substantial amendments, and the continued importance of local regulatory expertise despite anticipated IVDR updates.
Discussions around the future of European regulations continued during the MDR 2.0: Kick-off Panel 2026, featuring Gert Bos. The panel focused on balancing innovation, flexibility, and patient safety while addressing concerns from hospitals and healthcare institutions around device availability, in-house innovation, spin-offs, and ongoing clinical research activities.
This theme also played a central role in the Simplification and Centralization session, seeing Gert as moderator. Rather than focusing on “de-regulation”, the discussion emphasized simplification through risk-based oversight and more efficient regulatory processes. Panelists debated how the industry can maintain high standards of patient safety while creating a more workable and sustainable regulatory environment.
One of Qserve’s featured presentations, From MDR/IVDR 1.0 to 2.0: Real-World Data Driving Smarter Evidence Strategies, delivered by Wouter Mattheussens and Gert Bos, focused on the evolving role of PMCF activities in generating Real-World Data and Real-World Evidence for medical devices.
The session explored practical approaches, including registries, surveys, telemetry data, and patient-reported outcomes, highlighting how manufacturers can select the most appropriate PMCF tools to address clinical evidence gaps throughout the product lifecycle. While the proposed MDR 2.0 updates may simplify certain processes, the presentation reinforced that strong clinical data collection strategies remain essential for demonstrating safety and performance.
Clinical evidence was further discussed during Clinical Evidence as the Cornerstone of MDR Compliance: Lessons, Challenges, and the Road Ahead. Together with representatives from Kiwa Italy Notified Body and the Ethics Committee Romagna Region, Wouter Mattheussens explored the importance of robust clinical strategies that combine both pre-market and post-market activities. The panel emphasized that clinical evidence should ultimately demonstrate the real interaction between a device and the patient, while remaining adaptable to evolving expectations and regulatory requirements.
The interactive Solutions Circle: Compliance Amidst Uncertainties for Medical Devices sessions generated particularly strong engagement from conference attendees. Co-hosted by Gert Bos, the discussions focused on the many parallel challenges currently impacting the MedTech industry, including evolving global regulations, economic pressures, AI implementation, and workforce development.
The sessions encouraged open dialogue between participants, with attendees sharing practical experiences and action points while building new professional connections to support one another moving forward.
Kristiane Schmidt also joined the session First Time Right – Best Practices for Generation of High-Quality Data in IVDR Performance Studies. Together with fellow experts from industry and notified bodies, the panel discussed strategies for generating high-quality clinical evidence for IVDs, including post-market studies for legacy devices, common technical documentation gaps, and the importance of Good Clinical Practice to ensure data integrity and IVDR compliance.
Meanwhile, Dennis Sarwin presented key insights during the UK MDR session, focusing on the evolving UK regulatory framework and what it means for non-UK manufacturers. Topics included international reliance pathways, updated classification rules, software and AI requirements, MHRA registration planning, and vigilance reporting obligations. The session highlighted the growing importance of proactive collaboration with UK Responsible Persons to successfully navigate upcoming changes.
Qserve’s final contribution came from Patrícia da Silva Perez during the Biocompatibility – ISO 10993 session. The presentation examined the significant conceptual and practical updates introduced in ISO 10993-1:2025 and highlighted how biological evaluation should be viewed as a continuous risk management process rather than a static documentation exercise.
The session reinforced the importance of integrating clinical and post-market data into biological evaluations to continuously support medical device safety throughout the device lifecycle.
RAPS Euro Convergence 2026 once again demonstrated the importance of collaboration across the MedTech ecosystem. As regulations continue to evolve globally, open dialogue between manufacturers, regulators, notified bodies, healthcare institutions, and service providers remains essential to support innovation while safeguarding patient safety.
We would like to thank everyone who joined our sessions, contributed to the discussions, and connected with our team throughout the event. We look forward to continuing these conversations in the months ahead.
If you would like to continue the conversation or discuss any of the topics covered during RAPS Euro Convergence 2026, our team would be happy to connect. Whether your questions relate to MDR and IVDR compliance, clinical evidence strategies, PMCF activities, UK MDR developments, IVD performance studies, biocompatibility, or broader regulatory challenges, Qserve’s experts are here to support you.
Feel free to reach out to us to explore how we can help navigate your regulatory, clinical, and quality challenges.