Date: 20 January 2026
Time: 16:00 - 17:00 CET | 10 - 11 am EDT
Location: Virtual
Introduction
The European Commission’s MDR 2.0 proposal marks a significant update to the EU’s medical device regulatory framework. Designed to address ongoing challenges with the current Medical Devices Regulation (MDR), the draft aims to streamline procedures, improve coordination among authorities, and reduce unnecessary burdens on manufacturers. The proposal is now with the European Parliament and Council for review and negotiation.
To help you understand what’s in the draft and what it means for the medical device sector, this webinar brings together expert speakers in EU regulatory affairs and compliance. We’ll highlight the key changes proposed under MDR 2.0, explore their potential impact on industry and stakeholders, and offer practical insights to help you prepare for the next phase of regulatory developments.
The webinar consists of a 15-minute presentation, a 30-minute panel discussion, and a 15-minute live Q&A session. Questions for the Q&A can be submitted through the registration form, by email at marketing@qservegroup.com, or during the webinar.
Learning Objectives:
1. Learn about the new legal proposal
2. Hear the first impact assessment
3. Understand the proposed key changes and implications
4. Gain insight into the Notified Body’s perspective on MDR 2.0
Who should attend?
This webinar is designed for medical device manufacturers seeking clarity on the MDR 2.0 proposal and its potential impact on product development, certification, and market access. It’s particularly relevant for:
- Regulatory affairs and compliance professionals
- Quality assurance and quality management teams
- R&D and product development leaders
- Market access and clinical affairs specialists
- SME manufacturers navigating resource-intensive compliance
- Executive and strategic decision-makers responsible for EU market planning
Agenda
- Welcome & Introduction
- Purvi Patel – Notified body perspective
- Fabien Roy – Legal essentials
- Industry – A first read
- Panel discussion
- Live Q&A