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:

1. Studies wherein invasive sampling is exclusively undertaken for the data collection specific to the performance investigation.

2. Interventional clinical performance studies, where the outcomes of the diagnostics have the potential to inform and alter patient care strategies or influence therapeutic choices.

3. Studies that incorporate additional invasive procedures or present supplementary risks to the participants.

4. 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.