What is the webinar about?

This webinar is focused on preparing medical device and IVD stakeholders for the upcoming mandatory use of EUDAMED (the European Database on Medical Devices) starting May 28, 2026. It explains:

  • The first four modules of EUDAMED that will become mandatory 
  • Key timelines leading up to and after May 2026 
  • Updates to BSI processes to align with EUDAMED requirements 
  • Required actions for different actors, including: 

                - Manufacturers

                - Importers

                - EU Authorized Representatives 

                - Notified Bodies 

Who should attend? 

  • Medical device and IVD manufacturers working with us under MDR/IVDR
  • Organizations that will need to use EUDAMED 
  • Even non-BSI clients who want insight into how EUDAMED works and how BSI is handling it 

What will participants gain?

It’s a practical, compliance-focused session designed to help organizations get ready for mandatory EUDAMED use and understand how it will impact their regulatory responsibilities and interactions with BSI. 
 

Speakers

Sofia
Palm
Regulatory Lead
 
 
Susan
Partridge 
Regulatory Lead - Clinical Compliance
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