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Performance Study Documentation

Certain IVD performance studies and non-CE marked diagnostic tests used in clinical trials must be approved by national competent authorities, based on performance study documentation. Qarad can guide you through the Annex XIV study submission process.

EU Regulatory Requirements for Performance Studies

When orchestrating a performance investigation within the European Union, the following types of studies necessitate authorization from the pertinent regulatory bodies:

  • Studies wherein invasive sampling is exclusively undertaken for the data collection specific to the performance investigation.
  • Interventional clinical performance studies, where the outcomes of the diagnostics have the potential to inform and alter patient care strategies or influence therapeutic choices.
  • Studies that incorporate additional invasive procedures or present supplementary risks to the participants.
  • Studies involving companion diagnostics that are not limited to the analysis of residual specimens.

Authorization for such studies is contingent upon the submission of comprehensive documentation in strict adherence to Annex XIV of the In Vitro Diagnostic Regulation (IVD-R). It is imperative to acknowledge that this requirement extends to the utilization of in vitro diagnostic tests that have not yet been marked with a CE label, particularly when employed in clinical drug trials within the EU and the test results are integral to patient management or therapeutic direction.

Before the study can start, a positive opinion must be obtained from the ethics committee and the study must be approved by the competent authority of each EU member state where the study will take place. Amongst the documentation to be submitted to competent authorities are:

  • the General Safety and Performance Requirements (GSPR) checklist,
  • the Clinical Performance Study Protocol (CPSP),
  • the Investigator’s brochure (IB),
  • the Informed Consent Form (ICF),
  • and other information such as
    • the device Performance Evaluation Plan (PEP),
    • existing clinical data 
    • and the summary of the benefit-risk analysis and risk management. 

Each member state may require additional information to be provided. Moreover, if the sponsor of the performance study is established outside of the EU, it must appoint a legal representative within the EU.

Why Qarad?

Qarad can guide you through the Annex XIV study submission process, whether your device is a companion diagnostic, a lab test used in clinical trials, or a ‘regular’ IVD under development. Our consultants are ready to support you with strategic regulatory advice, and we offer legal representative services. 

What’s more, our team of medical writers can support you in either writing or reviewing the documentation that must be submitted. We have the intelligence that each member state specifically expects as documentation and also bring our in-house experience to what type of questions you can expect during the review and how long such an application takes from submission to approval.

We help you in achieving successful Annex XIV submissions, thereby shortening the lag time to start the performance study – and possibly the clinical trial associated with it.

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