The European Medical Device Regulation (MDR) continues to evolve, and discussions around the Commission proposdal (so-called) “MDR 2.0” highlight the need for ongoing adaptation by manufacturers, notified bodies, and regulatory professionals. But what exactly does “MDR 2.0” the proposal say, what may it mean in practice, and how might it impact your organization?
This webinar provides a deep dive into the Commission’s proposal MDR 2.0 itself with the aim to provide as a structured and practical overview of what has been proposed —exploring the What (the details within), Why (background / drivers), How (mechanics needed to make it work), When (impact on timelines), Where (where are decisions being made), and Who (is impacted) behind proposed changes and what it may mean in the ever-evolving EU regulatory landscape. In addition, what current challenges for medtech not addressed by the MDR 2.0 proposal will be discussed with areas of potential improvements.
Learning Objectives
By the end of this session, participants will:
- Understand the general topics covered in MDR 2.0 and its current status along with areas not covered in the proposal.
- Gain actionable insights for navigating uncertainty and preparing for upcoming updates.
Who Should Attend
- Regulatory Affairs professionals
- Quality and Compliance leaders
- Medical device manufacturers (all classes)
- Clinical and Technical documentation specialists
- Senior management involved in EU market strategy
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speaker
Elizabeth Gfoeller
