RAPS Euro Convergence 2026: EU MDR & Regulatory Tech

Key Takeaways

• RAPS Euro Convergence 2026 will be held May 5-8 in Lisbon, Portugal.
• The conference will focus on EU MDR/IVDR updates, combination products, and advancements in regulatory technology.
• Celegence and other key sponsors are scheduled to present on critical regulatory topics.

The RAPS Euro Convergence 2026 will bring together regulatory affairs professionals in Lisbon, Portugal, from May 5-8 to discuss key issues impacting the pharmaceutical, medical device, and IVD industries. The event will take place at the Lisbon Congress Centre.

This conference serves as a crucial platform for regulatory experts to exchange knowledge and strategies related to the evolving regulatory landscape. With a focus on EU MDR/IVDR implementation, combination products, and the integration of regulatory technology, the event aims to provide attendees with actionable insights to navigate complex regulatory challenges.

Featured Presentations

Several key presentations are scheduled during the conference:

• Celegence: On Thursday, May 7, from 14:00–14:25 WEST, Celegence will present on EU MDR Article 117, focusing on regulatory strategies for drug-device combination products. The presentation will cover Notified Body roles, dossier integration, documentation, and compliance challenges. The session will take place in the Exhibition Hall – Discover at Booth 38.
• MedEnvoy: On Wednesday, May 6, during the lunch break, MedEnvoy will discuss ensuring compliance across the distribution chain, with a deep dive into the roles of economic operators.

IntelligenceRegulatory Impact▾

EMA and MHRA are the agencies to watch. Regulatory relevance reads medium for regulatory. Teams should track submission types, designations, and guidance shifts that could move approval timelines.

Key Regulatory Topics

The RAPS Euro Convergence 2026 will address several important regulatory topics:

• EU MDR/IVDR Developments: A central theme of the conference will be the latest developments and implementation challenges related to the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR).
• EMA Updates: Discussions will include updates from the European Medicines Agency (EMA) on topics such as biosimilars and clinical trial guidelines.
• Data-Driven Regulatory Practices: The event will explore the increasing importance of data in regulatory decision-making and compliance.

IntelligenceCompetitive Intelligence▾

Competitive pressure is low. Watch which sponsors move first. Benchmark pipeline positioning, differentiation, and partnership scouting against the signals in this story.

Sponsors and Exhibitors

Key sponsors and exhibitors at the RAPS Euro Convergence 2026 include:

• Celegence: As an Innovator Sponsor, Celegence will host a session on EU MDR Article 117 at Booth 38.
• Cisema: Cisema will exhibit, focusing on regulatory pathways for drug and combination product registration in the EU, China (NMPA), and the US.

The event provides valuable opportunities for attendees to connect with these and other key regulatory stakeholders.

IntelligenceMarket Signals▾

Commercial pull is medium and investment relevance low. Expect implications for regulatory pricing, access, and launch sequencing.

Market & Investor Implications

The RAPS Euro Convergence 2026 offers significant value for market participants and investors by providing insights into the evolving regulatory landscape. Understanding the implications of EU MDR/IVDR, the regulatory pathways for combination products, and the role of regulatory technology is crucial for strategic decision-making and investment in the pharmaceutical and medical device sectors.

IntelligenceStrategic Takeaways▾

RAPS Euro Convergence 2026 will be held May 5-8 in Lisbon, Portugal. The conference will focus on EU MDR/IVDR updates, combination products, and advancements in regulatory technology. Celegence and other key sponsors are scheduled to present on critical regulatory topics.

What to Watch Next

Looking ahead, stakeholders should monitor the ongoing implementation of EU MDR/IVDR, the development of new regulatory technologies, and the evolving guidelines for combination products. Staying informed about these developments will be essential for maintaining compliance and driving innovation in the life sciences industry.

Frequently Asked Questions

• What is the RAPS Euro Convergence 2026?

  It is a conference focused on regulatory affairs for pharmaceuticals, medical devices, and IVDs, taking place in Lisbon, Portugal, from May 5-8, 2026.

• Where is the RAPS Euro Convergence 2026 held?

  The event is held at the Lisbon Congress Centre in Lisbon, Portugal.

• What are the main topics covered at the conference?

  Key topics include EU MDR/IVDR developments, combination products, and regulatory technology advancements.

• Who are some of the key sponsors and exhibitors?

  Celegence and Cisema are among the key sponsors and exhibitors at the event.

• What is EU MDR Article 117?

  EU MDR Article 117 pertains to the regulatory requirements for drug-device combination products, including Notified Body roles and dossier integration.

References

• Celegence RAPS Euro Convergence 2026 Event Page
• Intuition Labs Conferences
• MedEnvoy at RAPS Euro Convergence 2026

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