Home Knowledge Act Now to be Ready on Time – Guide to New Classification Rules for In Vitro Diagnostic Medical Devices

Act Now to be Ready on Time – Guide to New Classification Rules for In Vitro Diagnostic Medical Devices

July 29, 2020
Partner
Laura Scott
Partner
Charleen O’Keeffe

 

In advance of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (the IVDR) becoming fully applicable on 26 May 2022, we outline the key changes to the classification of in vitro diagnostic medical devices (IVDs).

In this briefing we cover:

  • Classes of IVDs
  • Classification Rules
  • Impact of Classification Changes
  • Device Identification

 

Contributed by Laura Casey

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