What is the webinar about?

Under MDR, Article 117 has significantly increased the regulatory requirements. In many cases, this now requires the involvement of an MDR-designated Notified Body, providing a formal Notified Body Opinion (NBOp).  
If you manufacture combination products, this webinar will help you:

  • to understand how these changes are affecting you;
  • prepare documentation;
  • and submit your products for review.

What will participants gain?

  • Understand what Article 117 means for your next submission
  • Learn which documents Notified Bodies expect (and why)
  • Learn how to reduce rework and regulatory queries
  • See how the NBOp process works in practice
  • Participate in a live Q&A

Speakers

 
Theresa
Jeary
Global Head — Medicinal & Biologics, BSI
 
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