Performance studies using in-vitro diagnostics (IVDR)

Specific rules for the submission, assessment and conduct of in vitro diagnostic medical device (IVD) performance studies are set out in the EU In Vitro Diagnostics Regulation (EU no 2017/745, IVDR). As of 26 May 2022, IVDs must comply with new European rules.

IVD performance studies are divided into different legal frames. These frames are described in Legal framework, guidances and standards.

For information on the submission and contents of the research file, please visit Primary submission and Standard research file IVD performance studies.

During and after IVD performance studies provides information on what to report during and after the study.

Information on starting an appeal against or objection procedure to a decision by the accredited MREC or CCMO is available on Appeal and objection.