At the end of 2025, the European Commission published a series of legislative proposals aimed at refining and adapting the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), marking a decade since their original publication. These proposals seek to strengthen innovation, enhance EU market attractiveness, and improve predictability and transparency, while maintaining the highest standards of patient safety.
During this presentation the proposals and justifications will be explained by discussing the opportunities and challenges related to each recommended measure. Participants will gain clear insights into the evolving legislative landscape and what these changes may mean for future regulatory strategies in the EU.
Key topics include:
- Current legislative status and next steps
- Proposed changes to Annex VII and implications for the Notified Body process
- High-level overview of the Commission’s proposed measures
- Detailed review of key targeted amendments
- Simplification, proportionality, and cost-saving initiatives
- Innovation support mechanisms and special access pathway
Accommodations & Travel Information
Abbott- Conway Park
675 N Field Dr
Lake Forest, IL
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
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
Dr Bassil Akra
