Module 18 2021

06/02/2021

CDx requirements under IVDR – Clinical Affairs Challenges & Questions

a. Following gap analysis of existing CE-IVDs, additional clinical validation data may be needed to meet IVDR requirements - do we have enough time? b. Come May 2022 FDA PMA data may/may not fulfill Annex XIV requirements. Therefore, consideration must be made for supply of CE-IVD kits in RoW where the CE-Mark cannot be maintained under IVDR c. Also, how do we continue supply kits to existing interventional CDx clinical trials conducted in EU with a non CE-marked kit? d. Label Performance Evaluation Only? – who obtains CA approval for this? Pharma or Diagnostic Sponsor, both?

1. Can the clinical evidence gaps be filled in time?

The Organisation for Professionals in Regulatory Affairs

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CDx requirements under IVDR – Clinical Affairs Challenges & Questions

CAs are not ready to accept Clinical Trial Applications for review with IVDR in mind

Nor are NBs and EMA/National CAs ready to accept submissions for conformity assessments and scientific opinions respectively, as required for CE marking under IVDR Since the roadmap is not ready, combined with impact of Coronavirus pandemic, a delay to IVDR implementation has been proposed by Labs and Hospitals among other authorized representatives Meanwhile, we are getting ready for May 2022 but continue to seek the guidance needed on how to implement all aspects of the IVDR into our current and future CDx studies.

2. Can a clinical trial be initiated today under IVDR?

The Organisation for Professionals in Regulatory Affairs

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