Overview
Format
In person
Timing
7 AM – 4 PM WEST
Event Dates: Tuesday, May 5 – Friday, May 8, 2026
Location: Lisbon Congress Centre, Praça das Industrias, 1, Lisbon, Portugal
Booth: 38
Event Website: RAPS Convergence 2026
Registration: Register here
Celegence will be attending RAPS Euro Convergence 2026 as an Innovator Sponsor, joining regulatory leaders from across Europe and globally at one of the most important conferences for healthcare product regulation.
From 5–8 May, the Lisbon Congress Centre will bring together professionals across pharmaceuticals, medical devices, IVDs, and combination products to discuss the latest regulatory developments shaping the industry.
Visit us at Booth 38 to connect with our team, explore our technology-enabled regulatory services, and see how organizations are improving submission timelines, quality, and compliance through a structured Service + Technology approach.
Sponsored Presentation – EU MDR Article 117
📅 Date: Thursday, 7 May
🕘 Time: 14:00 – 14:25 WEST (Lunch Break – Round 2)
📍 Location: Exhibition Hall – Discover
EU MDR Article 117 has introduced a significant shift in how drug–device combination products are evaluated for EU market access.
In this session, Celegence experts will provide a practical perspective on Article 117 requirements, including:
- The role of Notified Bodies in the evaluation process
- Integration of device conformity into the medicinal product dossier
- Documentation expectations for submissions and lifecycle changes
- Common compliance challenges and how to address them
The discussion will also include real-world considerations to support efficient development, submission, and lifecycle management of combination products.
What You Will Learn:
- Regulatory intent and scope of EU MDR Article 117 for integral combination products
- Notified Body involvement, opinion types, and required documentation
- Practical strategies to align pharmaceutical and medical device development activities
- Approaches to reduce regulatory risk and avoid delays in approval timelines
Meet the Celegence Team
Our team will be available throughout the event at Booth 38:
- Cheryl Jessen – Chief Revenue Officer
- Stef Schutte – SVP Regulatory Affairs & General Manager
- Joseph Richardson Larbi – Director SME, Medical Device Services
- Matt Tyler – VP Business Development & Partnerships
Connect with us to discuss your regulatory priorities, current challenges, or upcoming submissions.
What You Can Explore at Booth 38
Stop by our booth to:
- Explore how AI can streamline CERs, PERs, SLRs, and technical documentation
- Understand how Celegence delivers MDR/IVDR-compliant documentation within weeks, rather than months
- Discuss your regulatory challenges with experienced professionals
- See demos of our AI-powered regulatory technology
Why Attend RAPS Euro Convergence 2026
RAPS Euro Convergence continues to be a key platform for regulatory professionals to stay updated on:
- EU MDR and IVDR developments
- Combination product regulatory pathways
- Evolving expectations from Notified Bodies
- Data-driven and technology-enabled regulatory practices
The event offers a strong mix of strategic discussions and practical insights that can be applied across regulatory teams.
Let’s Connect in Lisbon
Celegence supports pharmaceutical and medical device organizations with a structured, scalable approach to regulatory execution, combining experienced professionals with AI-enabled technology.
Register now to attend and make sure to add our session to your agenda.
If you would like to schedule a meeting or connect with our team during the event, reach out to us at info@celegence.com. We look forward to connecting with you in Lisbon.