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Format
Online
Webinar -
Date
April 20th, 2026
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Time
12:00-15:00 CET
Recording will be available for up to 6 months -
Level
All
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Price
Free
MDR Revision: Data, Digital, AI ACT, Role of EMA, IVD / In-house, Legislative Process
This event is the last part of our series of three in depth afternoons dedicated to MDR revision, but can be also attended as a standalone version.
The MDR Revision Mini-Course is a three-part webinar series designed to equip regulatory professionals with a clear, practical understanding of the ongoing MDR revision process and its potential implications for the medical device sector. This series reflects a needs-based learning approach: focusing on what professionals actually need to know to navigate regulatory change effectively, rather than abstract or purely academic discussions.
This final webinar broadens the view to cross-cutting topics within the MDR & IVDR revision process, especially but not exclusively IVD testing. It further includes digital health, AI-related regulation and the role of EMA as well as in-house device considerations. It also offers insight into how the legislative process itself functions and where stakeholders can meaningfully engage. Drawing on legal, academic, notified body, and industry expertise, the session helps participants understand how interconnected regulatory frameworks are evolving and how MDR and IVDR revisions may align with broader EU legislation. The focus remains on enabling informed understanding rather than advocacy, supporting confident, independent engagement with regulatory developments.
The MDR Revision Mini-Course is a three-part webinar series designed to equip regulatory professionals with a clear, practical understanding of the ongoing MDR revision process and its potential implications for the medical device sector. This series reflects a needs-based learning approach: focusing on what professionals actually need to know to navigate regulatory change effectively, rather than abstract or purely academic discussions.
While each webinar can be attended as a standalone session, together they provide a coherent and comprehensive overview of where the MDR revision stands, how the legislative process is unfolding, and what this may mean for manufacturers, notified bodies, and other stakeholders. The aim is not to formulate positions or comments within the course itself, but to empower participants with the knowledge required to critically assess developments and, if appropriate, contribute informed feedback to the legislative process independently.
The webinars bring together perspectives from industry, notified bodies, legal experts, and academia, creating a balanced and practice-oriented dialogue across key MDR topics, including clinical evidence, classification, conformity assessment, data and digital health, and the broader legislative framework.
This course is intended for anyone working in regulatory affairs, whether consultants, RA specialists, senior management, or professionals with adjacent regulatory responsibilities, who want to stay informed, understand the context behind regulatory change, and confidently engage with the evolving MDR landscape.
This final webinar broadens the view to cross-cutting topics within the MDR & IVDR revision process, especially but not exclusively IVD testing. It further includes digital health, AI-related regulation and the role of EMA as well as in-house device considerations. It also offers insight into how the legislative process itself functions and where stakeholders can meaningfully engage. Drawing on legal, academic, notified body, and industry expertise, the session helps participants understand how interconnected regulatory frameworks are evolving and how MDR and IVDR revisions may align with broader EU legislation. The focus remains on enabling informed understanding rather than advocacy, supporting confident, independent engagement with regulatory developments.
Meet the speakers
Michael D'Agosto
Moderator
Professor for Biomedical Engineering, Dean of Studies M.Sc. Medical Devices - Regulatory Affairs
Cécile van der Heijden
Legal: Data, Digital, AI ACT, Role of EMA, legislative process
Attorney-at-law | Senior Legal Counsel at Axon Lawyers | FemTech, MedTech, AI, Data & Biotech
Nina Dusper
Industry: Data, Digital, AI ACT, Role of EMA
Head of Quality and Regulatory Affairs at RetInSight
Folker Spitzenberger
Academic: IVD / In-house, Legislative process
Professor for Regulatory Affairs for medical devices, University of Applied Sciences Lübeck (TH Lübeck), Germany
Stephen Gilbert
Industry: Data, Digital, AI ACT, Role of EMA
Professor - Medical Device Regulatory Science, News and Views Editor, Nature Portfolio - Digital Health
And more...
Bundle offer
MDR Revision: Mini series
A three-part webinar series designed to equip regulatory professionals with a clear, practical understanding of the ongoing MDR revision process and its potential implications for the medical device sector.
While each webinar can be attended as a standalone session, together they provide a coherent and comprehensive overview of where the MDR revision stands, how the legislative process is unfolding, and what this may mean for manufacturers, notified bodies, and other stakeholders.
We offer a reduced rate for anyone, who would like to take part in all three.
Courses included:
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