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IVDR Clinical Evidence: EU Guidance Document Spells Out What Is Required

 
• By Amanda Maxwell

The long-awaited guidance on how to collect and maintain clinical evidence for diagnostic tests under the IVDR has now been published. It reflects the need for a lifecycle approach to device development and regulation.

Gloved hand performs COVID-19 testing in a laboratory setting.
• Source: Alamy (tilialucida / Alamy Stock Photo/Alamy Stock Photo)

Guidance on the general principle of clinical evidence for IVDs has been published by the European Commission’s Medical Device Coordination Group.

The 31-page document, MDCG 2022-2, is the second guidance document to be issued this year, features five-and-a-half pages on definitions alone.

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