Last week, the MedTech regulatory community gathered in Lisbon for RAPS Euro Convergence 2026: nearly 100 sessions, hundreds of professionals, and one overriding theme: transformation.The European regulatory landscape is shifting faster than it has in two decades, and the pressure is on every RA team to keep pace.
We were there. And here is what we took away.
The Dominant Signal: Change Is Accelerating
For MedTech manufacturers, the immediate reality is demanding. MDR 2.0 is advancing. The EU AI Act is creating new compliance obligations for software-enabled devices. EUDAMED continues to mature. And teams are being asked to absorb all of this while still meeting existing registration and renewal deadlines.
The practical implication is clear: RA functions that rely on manual tracking, disconnected spreadsheets, and tribal knowledge are being outrun by the pace of change. Across the industry, teams are moving from talking about AI to actively experimenting with it, using it to handle the volume and complexity that manual processes simply cannot absorb. The teams emerging as strategic forces are the ones who have connected, real-time regulatory infrastructure and are putting AI to work within it.
AI Is No Longer Optional Thinking
The conversation at Euro Convergence made one thing clear: AI has moved from future-state to present-tense. Regulatory professionals were encouraged to embrace AI while maintainingaccountability for the outcome and challenging the algorithms.
" Our role is to make sure that the AI does the right interpretations appropriate to our products, to our business."
— João Martins, Director of Regulatory Affairs at Abbott at RAPS Euro Convergence 2026 Opening Plenary
That framing resonates deeply with how we have built AI into Rimsys. The goal was never to replace regulatory judgment; it is to amplify it. Rimsys AI is domain-specific, built on the regulatory data structures and logic that reflect real-world requirements, country-specific nuances, and product context. It proposes, analyzes, and alerts. Your team reviews, approves, and decides.
For teams that are ready to accelerate, Rimsys AI accelerates regulatory intelligence monitoring and submission authoring, removing the repetitive, detail-heavy work so skilled professionals can focus on strategy, market expansion, and the higher-order decisions that increasingly complex regulations demand.
"As future regulators, we will need to be scientifically strong, comfortable with complexity, open to innovation, and also be able to work in increasingly complex environments."
— Rui Santos Ivo, President of Portugal's National Authority of Medicines and Health Products (INFARMED) and chair of the EMA management board, RAPS Euro Convergence 2026 Opening Plenary
MDR 2.0: Reform With Guardrails
A panel of experts representing regulators, industry, and notified bodies gave their views on the proposed revision of the EU Medical Device Regulation at the conference. While their sentiments were largely supportive, notified body representatives urged the European Commission to maintain proactive surveillance of devices to protect patients.
The discussion acknowledged the complexity of balancing reform with patient safety. Simplification and innovation go hand in hand, though if it is overly complicated or overly simplified, it becomes difficult to innovate. Structured dialogues in MDR/IVDR will provide transparency and predictability for manufacturers, especially in early product development.
Regulatory Workflows Cannot Be an Afterthought
A recurring observation across sessions was that MDR 2.0, EUDAMED, and the EU AI Act are only as effective as the operational workflows behind them. Structured dialogues, risk-proportionate pathways, and submissions all require teams to move quickly with accurate, up-to-date product data. That is simply not possible when that data lives across email threads, spreadsheets, and disconnected systems.
The workflows that came up most in Lisbon (change control, renewals, new product introductions, and registration management) are exactly the areas where manual processes create the most risk. A missed renewal. A design change that triggers 40 country-level impact assessments with no system to coordinate them. A registration record that no one has updated since the last audit.
Rimsys keeps these workflows connected and proactive. Renewal expiration reminders fire before deadlines become a risk. Change control impact surveys are configurable to your SOPs, so teams can assign tasks and coordinate work across regions without relying on someone to manually track progress. New product introductions move faster because previous submission content can be reused across markets. Target market data, registration history, and approval status are already centralized, so teams are building on existing work rather than starting from scratcheach time.
The result is regulatory operations that reduce time to market by weeks to months, not add to it. Access information in seconds rather than hours. Regulatory release authorization in minutes rather than weeks. More than 90% reduction in regional regulatory reporting time. These are not projections. They are outcomes reported by Rimsys customers operating in exactly the kind of complex, multi-market environments that dominated the conversation in Lisbon.
The Regulatory Professional Is Evolving
Perhaps the most striking thread across sessions was the evolution of the RA function itself. Regulatory work was once seen mainly in terms of compliance procedures and submissions. Today, the profession is much broader than that.
This evolution is exactly the transition Rimsys is designed to support. When regulatory data is centralized, connected, and visible in real time, RA teams stop spending their days chasing down registration status and start contributing to commercial strategy: market expansion decisions, launch sequencing, change control planning, and executive-level risk communication.
The heart of regulatory operations is not a filing cabinet. It is a living, connected system that elevates the entire function.
What It All Points To
RAPS Euro Convergence 2026 made one thing clear: the organizations that will thrive are those who have invested in regulatory infrastructure that can absorb change without breaking. Rimsys is the platform built for exactly this moment: enterprise-grade, intuitive enough for global teams to actually use, and trusted by 6 of the top 12 global MedTech manufacturers worldwide.
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