From AI to regulatory layering and convergence: Key takeaways from RAPS Euro Convergence 2026

Artificial intelligence was a recurring topic across sessions, particularly in relation to safety, responsibility, and its role in regulatory submissions and conformity assessment. The direction is clear: AI will become part of regulatory workflows, but the level of maturity across the ecosystem remains uneven.

Discussions focused less on how to use AI effectively and more on how to control and govern its use. Even in areas such as conformity assessment, experts emphasized that responsibility cannot be delegated. Manufacturers and authorities remain accountable for outcomes, regardless of automation. At the same time, developments outside Europe show that adoption is already progressing. The US Food and Drug Administration (FDA) has introduced agentic AI capabilities to support complex regulatory processes, such as pre-market reviews, post-market surveillance, inspections, and compliance activities.¹

In parallel, new regulatory approaches are emerging to address the unique challenges of AI-based technologies. During one session, Regulatory Sandboxes in Practice: Turning AI Airlock Learnings into Policy, Regulatory and Industry Strategy, speakers shared how The UK MHRA AI Airlock program has provided a regulatory sandbox for innovators and regulators to test AI as a medical device in controlled environments, generating insights that will shape future frameworks.

The EU perspective appears more cautious, but not static. Discussions at the conference highlighted a clear shift among notified bodies—from observing AI to actively preparing for its integration. Sessions on AI-powered conformity assessment explored concrete use cases, such as automated document management, intelligent review of large technical documentation sets, and predictive analytics to support assessment activities. These developments are closely linked to the European Commission’s targeted MDR/IVDR revision², which aims to improve predictability and efficiency in certification processes.

Despite this momentum, AI adoption remains at an early stage. Participants raised important questions about validation of AI tools, the development of robust quality assurance frameworks, and how to maintain independence, objectivity, and confidentiality within AI-enabled processes. What came across in AI discussions was that the real challenge is moving from controlled pilots and concepts to scalable, routine use within a highly regulated environment. For manufacturers, we believe this creates an important consideration. While AI-enabled conformity assessment is not yet standard, expectations around structured, consistent, and increasingly machine-readable documentation are likely to evolve quickly. Preparing for this shift now may become a competitive advantage.

There was a noticeable shift in how regulatory complexity is being framed during the conference. MDR and IVDR are no longer the “new challenge” they once were, since most organizations have now built baseline understanding and capability. Instead, there is a shift to what renowned life sciences lawyer Erik Vollebregt of Axon Lawyers, who presented at several sessions, refers to as “regulatory lasagna”, reflecting the complexity and layering of multiple regulatory frameworks being applied simultaneously, often without full alignment. The layering of regulatory frameworks fundamentally changes the nature of regulatory work. It is no longer a linear process aligned to a single framework, but a coordination exercise across overlapping regimes, timelines, and stakeholders.

This becomes particularly visible in digital areas. During a session titled Interoperability of Medical Devices in a Connected World – From Regulatory to Reality, speakers discussed how interoperability requirements for Software as a Medical Device will require manufacturers to address not only MDR expectations, but also broader data and digital legislation. These include the General Data Protection Regulation (GDPR), the European Health Data Space (EHDS), and the EU Data Act. Translating these requirements into coherent design, validation, and documentation strategies remains a significant challenge and often results in inconsistent submissions and delays.

A second layer of complexity comes from horizontal EU legislation, as discussed by Vollebregt and Darren Thain of medical devices company Smith+Nephew during the session titled Environmental Convergence: Horizontal EU Requirements Reshaping Medical Device and IVD Regulation. Environmental regulations—including the RoHS Directive (Restriction of Hazardous Substances in Electrical and Electronic Equipment)³ and REACH (the regulation on the registration, evaluation, authorisation and restriction of chemicals)⁴ —are increasingly intersecting with MDR and IVDR. These do not sit outside device regulation; they directly influence product design, materials, technical documentation, and lifecycle management.

One comment from the audience captured the operational impact particularly well. A participant highlighted that a single legal manufacturer may have multiple notified bodies assessing different parts of their portfolio, each operating in silos. When combined with overlapping regulatory requirements—environmental, digital, cybersecurity, and medical—this creates a situation where manufacturers are effectively responsible for ensuring alignment across both regulatory frameworks and multiple assessors, the audience member noted. In practice, this shifts the burden of integration from the regulatory system to the manufacturer.

The takeaway from the discussions is that regulatory work is becoming less about compliance with individual rules, and more about ensuring that complex systems function consistently and effectively.

Another strong signal from the conference was the ongoing transformation of pharmaceutical legislation and its implications for combination products. There was significant focus on the reform of EU pharmaceutical legislation—the first major overhaul in more than 20 years.⁵ The aim is to modernize the framework, improve access to medicines, support innovation, and streamline procedures, with an increasing emphasis on speed and efficiency.

Alongside legislative reform, the discussion also focused on evolving regulatory collaboration. Initiatives such as FDA–EMA parallel scientific advice⁶ aim to align expectations earlier in development, particularly for complex and combination products, supporting more efficient global development strategies.
Technical evolution is equally important, speakers noted. The revision of ICH M4Q (R2)⁷ introduces a more structured, lifecycle-oriented approach to pharmaceutical data, reflecting a broader shift toward digitalization and knowledge-based regulatory systems. Taken together, these developments signal that regulatory systems are evolving not only in their requirements, but also in how they process, structure, and assess information.

Discussions emphasized the distinct challenge these present for combination products, which must operate across regulatory frameworks that are increasingly connected, but not yet harmonized. This was also reflected in our own session “Life After NBOp: Navigating Post-Market Compliance and Mastering Change Management for Combination Products”. Device-related changes do not simply fit within pharmaceutical variation systems. After NBOp, each change must be assessed from both a medicinal product and device perspective—with clear justification and coordination.

In practice, this means that regulatory strategy for combination products can no longer be developed within a single framework—it requires early alignment across both medicinal and device regulatory pathways. Combination products are therefore not only technically complex, but structurally complex as well. Increasingly, this complexity will become the norm rather than the exception.