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

This session examines conformity assessment under the MDR, an area central to regulatory strategy and heavily affected by ongoing revision discussions. Experts from notified bodies, industry, legal practice, and academia will address current pain points, interpretative challenges, and potential directions of regulatory change. The webinar provides clarity on how classification decisions influence conformity assessment routes and notified body involvement. By unpacking real-world implications and regulatory reasoning, participants will strengthen their ability to assess proposed changes and understand how evolving interpretations may affect device lifecycle planning.

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.