IVDR

Tagged: CPSP, CPSR, IVDR, Performance

This topic has 1 reply, 2 voices, and was last updated 1 year, 9 months ago by Eldin Rammell.

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- July 19, 2022 at 3:11 pm #4698
  
  Catherine Lachapelle
  Participant
  
  Hello,
  Has the TMF RM been including new artifacts related to documents required by IVDR such as the Clinical Performance Evaluation Plan and Report? If so, in which Zone/Section/Artifact would you file those documents?
  Thank you!
- July 19, 2022 at 5:14 pm #4699
  
  Eldin Rammell
  Participant
  
  Hi Catherine
  
  I may be mistaken but isn’t the PEP and Report device-specific, rather than being study-specific? The TMF is a study-specific collection of documents. In a device context, it is those documents that relate to a specific clinical investigation, rather than a clinical summary for the device itself, si it would not contain the PEP and Report. Perhaps I’m mistaken so happy to be corrected.
  
  Kind regards
  Eldin.
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