Euro Convergence 2025 focuses on competing, adapting amid global change

Competitiveness and adaptability get high billing at RAPS Euro Convergence 2025 meeting in Brussels, with plenty of discussion about how to improve the region's global standing, alongside practical sessions on compliance with a multitude of new regulations.

The Euro Convergence meeting runs from Tuesday, 13 May to Friday, 16 May at the Square Brussels Meeting Centre in Brussels, Belgium. The meeting, held annually, brings together a diverse set of regulatory professionals for a broad program spanning pharmaceuticals, medtech, IVD, artificial intelligence (AI), software and cybersecurity.

The focus of the opening plenary on 13 May is The future of regulation and European competitiveness, featuring keynote panelist Peter Bischoff-Everding, PhD, legal officer in the European Commission's Directorate-General for Health and Food Safety, along with representatives from MedTech Europe and the European Medicines Agency (EMA).

Regulatory executives and officials in the European Union are adapting to big shakeups in regulatory frameworks, like the Medical Device Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR) and the ongoing EU pharma review, noted Kate Stockman, PhD, co-chair of the program planning committee. Stockman also flagged the impact of the EU Green Deal and the EU Clean Industrial Deal, which will be explored in meeting sessions on 14 and 15 May.

We are in this highly disruptive time from a number of angles across the legislative environment with a “high degree of change in how we work internationally,” said Stockman, the UK-based vice president of regulatory affairs, Europe, Middle East & Africa, at global consumer healthcare firm Kenvue.

“At the same time, there is increased attention on increasing Europe's competitiveness within the global landscape,” Stockman added.

In theory, legislation in the EU is harmonized, but there are still many nuances and different ways of working, market by market, so there are opportunities for simplification and reducing burdens on companies, she explained. The opening plenary will also cover ways to advance digital health agendas. The closing plenary on 16 May will focus on disruptive innovation, including AI, and leave attendees with some ideas about building regulatory affairs to meet the needs of the future.

Program committee member Gert Bos, PhD, noted that his company is holding a session on 15 May about navigating the political shifts in global regulatory affairs that may help attendees get to grips with trade policies and other international agreements, as well as armed conflicts, all of which influence legal requirements and market access.

“It's not about what is good or bad – or what should happen, but this is a reality that is changing your everyday life as a regulatory support in your company. So how do you work with this changing landscape?” said Bos, executive director and partner, at the Qserve Group, a medical device and IVD regulatory consulting firm in the Netherlands.

Bos also noted that attendees will have the opportunity to ask regulators questions during the Conversations that matter: Interactions with health authorities session on 14 May, which features officials from all over the world.

More pharma appeal

The Euro Convergence program includes large panels with multiple stakeholders and audience interaction, and smaller sessions where people will go much more in-depth about challenges and discuss ways to take problems off their to-do list, Bos said. Social events include the ticketed dinner at Plein Publiek BXL, located at the Palais de la Dynastie on the Mont des Arts in Brussels.

The program has more pharma content and sessions on CMC this year, as well as a panel addressing medicines shortages, a global issue affected by changes to supply chains.

“We're trying to reshape the pharma content to make it more relevant and appealing. Euro Convergence has historically been very medtech-focused,” Stockman explained.

In the medtech sessions, attendees can expect a lot of discussion about the MDR and IVDR.

“We've now been working on this for almost a decade. So what works, what doesn't work, and what do we need to change in the longer run to the legislation?” said MDR expert Bos.
Bos and other speakers will address ways to optimize regulatory processes during the interactive MDR Kick-off panel the morning of 14 May.

IVDR highlights

Regulations on the use of AI in products as well as for submissions of applications for devices and pharmaceutical products are another area executives are adapting to, with more robust requirements for data security and cyber security.

Program committee member Alexander Stock said that the AI sessions within the software/AI/cybersecurity track of the meeting are all very important.

“This year there's more clarity regarding the AI act, but however, there's still a lot going on at the Notified Bodies. It's a continuous, huge interest regarding AI topics,” said Stock, project manager in IVD medical device testing, TÜV SÜD (Technical Inspection Association South) in Munich.

Stock is a panelist on a 14 May session titled Mastering IVD software classification and overcoming PMS regulatory compliance challenges at the interface of the IVDR and the AI Act.

“It's quite a unique topic,” Stock said. “It's about the issues with classification, because this is very complex for IVD – you often have a reagent part, a software part, and an instruments part. These can be classified all together or independently, and this is not straightforward.”

Program committee member Marta Carnielli, head of certification, IVD, at TÜV SÜD, highlighted content related to high-risk IVD products.

A panel on 16 May will review developments with European Reference Laboratories (EURLs) in assessing Class D (high-risk) IVD devices. The EURLs have been up and running since October 2024.

“It's really the first feedback essentially six months after rapid implementation,” Carnielli said.

A session on 15 May will cover lessons learned with EURLs and the reality of implementation as of May 2025, a “critical IVDR milestone” for Class D device oversight, as all manufacturers should have established an IVDR-compliant quality management system by now.

Euro Convergence 2025 focuses on competing, adapting amid global change

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