During their structured dialog in the pre-application phase, manufacturers and notified bodies should agree on which evidence from previous applications can be reused.
Updated EU Guidance Reinforces How Notified Bodies Should Use Existing Evidence
Notified bodies’ conformity assessment processes can easily be streamlined and made potentially less costly within the context of the EU’s current regulations.
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AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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