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Updated EU Guidance Reinforces How Notified Bodies Should Use Existing Evidence

 
• By Amanda Maxwell

Notified bodies’ conformity assessment processes can easily be streamlined and made potentially less costly within the context of the EU’s current regulations.

Side-view mirror on car looking back
Looking Back May Speed Up The Onward Regulatory Journey • Source: Shutterstock

During their structured dialog in the pre-application phase, manufacturers and notified bodies should agree on which evidence from previous applications can be reused.

This clarification is featured in a new answer contained in the Medical Device Coordination Group’s just-released fifth revision of its Q&A document on Requirements Relating To Notified Bodies,

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