EU MDCG 2024-4:2024

Performance studies of in vitro diagnostic medical devices The reporting modalities and format set out in this guidance apply to: • Performance studies covered by IVDR Article 58(1): • in which surgically invasive sample-taking is done only for the purpose of the performance study; • that is an interventional clinical performance study as defined in IVDR Article 2(46); • where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies; • performance studies covered by IVDR Article 58(2) involving companion diagnostics (except when only using left-over samples); • PMPF studies covered by IVDR Article 70(1) that involve procedures additional to those performed under the normal conditions of use of the IVD and where those additional procedures are invasive or burdensome, in case a causal relationship between a SAE and the preceding performance study has been established; • performance studies covered by IVDR Article 70(2) that are conducted to assess, outside the scope of its intended purpose, an IVD that already bears the CE marking.