IVDR

[Catherine Lachapelle]

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!

[Eldin Rammell]

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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