This event is the first part of our series of three in depth afternoons dedicated to MDR revision, but can be also attended as a standalone version.

This webinar focuses on how the MDR revision process may impact requirements for clinical evidence. Through perspectives from notified bodies, industry, legal experts, and academia, the session explores current challenges, regulatory expectations, and areas under discussion within the revision process. Participants will gain insight into how evidence requirements are being debated, what potential changes could mean for innovative and niche devices, and how regulators and manufacturers view the balance between patient access and safety. The session aims to build a solid understanding of the regulatory context, enabling participants to follow developments and engage knowledgeably with future discussions.

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.