Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR
- usr192162
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- on Jul 03, 2023
Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR Unless you are currently selling high-risk IVDs in Europe, chances are your technical documentation has not been scrutinized by a European Notified Body. Soon, you will. Europe├óΓé¼Γäós new In Vitro Diagnostic Regulation (IVDR 2017/746) will impose strict new requirements on many IVD manufacturers […]
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