The 2025 RAPS Regulatory Convergence displayed significant developments shaping global medical device regulation. As the industry advances toward more data-driven, AI-enabled, and outcome-focused regulatory frameworks, the discussions highlighted how manufacturers can strategically strengthen compliance, accelerate global market access, and align with evolving expectations from regulators.

At Maven Regulatory Solutions, we continuously assess these global trends to guide manufacturers through the increasing complexity of medical devices and IVD regulations.

1. Key Themes from the Plenary Sessions

Regulatory professionals continue to emphasize the importance of scientific rigor, real-world evidence, transparent communication, and regulatory alignment. A notable discussion centered on the communication gap between regulators, healthcare professionals, and users particularly regarding the interpretation of safety, performance, and clinical evidence.

Core insights included:

• The need for clear, patient-centric Instructions for Use (IFU) and enhanced content structure.
• Increasing expectations for user-friendly device information beyond traditional documentation.
• The expanding role of clinicians in ideation, early prototyping, and usability evaluation, especially 3D printing and rapid prototyping technologies have become mainstream.
• Greater emphasis on demonstrating practical user safety benefits during early design and development.

These discussions reinforce that user-centricity, human factors engineering, and risk communication are becoming essential regulatory attributes rather than optional considerations.

2. Highlights from Educational Sessions: Europe, AI, and the Future of Regulation

European regulation dominated many technical sessions, with continued focus on the evolving EU MDR, IVDR, and the EU Artificial Intelligence Act. Stakeholders expressed strong interest in the upcoming revisions to the European regulatory framework, particularly around:

• Streamlined pathways for legacy devices
• Transparency improvements in EUDAMED
• Stronger governance of AI-enabled and Software as a Medical Device (SaMD) Products
• Lifecycle data management for high-risk devices
• Expectations for post-market clinical follow-up (PMCF) and performance      evaluation (PMP)

Structured dialogues were emphasized as a valuable tool for manufacturers, though most beneficial once a manufacturer is already preparing notified body submissions.

In Silico Modeling and Simulation (M&S)

Sessions encouraged integrating computer-based modeling, computational simulations, and digital twins into medical device testing strategies. M&S approaches are increasingly recognized for:

• Reducing the need for certain bench and animal tests
• Supporting clinical evaluation and PMCF strategies
• Strengthening benefit-risk justification
• Increasing regulatory confidence through reproducible model validation frameworks

These methods align with global trends toward model-informed regulatory decision-making (MIRDM) and can become a strategic advantage for manufacturers preparing 2026 regulatory updates.

3. Key Observations from the Exhibit Hall

Digital transformation was a defining theme. Exhibitors showcased regulatory automation solutions, artificial intelligence-based document processing, and global regulatory intelligence platforms. Presentations focused on:

• AI-driven regulatory impact assessment
• Automated QMS workflows
• Data governance for medical device software
• Integrated global market access tracking
• Predictive analytics for regulatory timelines

These technologies are becoming essential for organizations managing multiple markets, frequent regulatory changes, and complex technical documentation.

4. Strategic Recommendations for Manufacturers in 2025–2026

To remain competitive under fast-evolving regulatory frameworks, manufacturers should prioritize:

1. Early regulatory planning and gap assessments aligned with EU MDR/IVDR revisions.
2. Strengthening clinical evidence and real-world data integration across device lifecycle.
3. Implementing digital traceability and documentation management tools for efficiency and audit readiness.
4. Leveraging in silico and computational modeling to optimize testing programs.
5. Ensuring AI/ML-based devices meet EU AI Act and global algorithm transparency requirements.
6. Enhancing risk management maturity with continuous post-market surveillance and signal detection systems.
7. Building robust global regulatory intelligence programs to anticipate changes and maintain market continuity.

Conclusion

Maven Regulatory Solutions remains dedicated to supporting manufacturers as they navigate complex global regulatory environments. The insights from RAPS 2025 reinforce the need for strategic planning, strong regulatory evidence generation, and adoption of advanced technologies to achieve global medical device success.

We continue to provide expert guidance across the full regulatory lifecycle helping companies align with evolving expectations, reduce compliance risk, and accelerate international market access.