IVD Medical Device Clinical Performance Evaluation Studies

In Europe, certain in vitro diagnostic (IVD) devices must undergo clinical performance (CP) evaluation studies conducted in accordance with current regulations in order to obtain CE Marking. For IVD manufacturers, the new In-Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 will significantly increase the need for these CP studies starting in May 2022. Failure to comply with IVDR CP study requirements may cause delays or non-approval of CE Marking. This white paper focuses on:

• Requirements for CP evaluation studies under the current European In Vitro Diagnostic Medical Devices Directive (IVDD) as well as under the new IVDR
• The ISO 20916 standard covering CP studies for IVDs
• CP studies for companion diagnostic (CDx) products
• The main obstacles for existing or new clinical performance evaluation studies

About the authors

Dietmar Falke, Ph.D., heads the Clinical Research team at Emergo® by UL. For more than 13 years, Dr. Falke has been involved in or responsible for conducting pharmaceutical and medical device clinical studies. He has broad experience in project management of clinical studies, from trial design to the generation of the final report, including submission to authorities and ethics committees.

Oliver Eikenberg, Ph.D., has over 17 years of medical device regulatory experience combined with technical hands-on experience in device development, manufacturing and product management. In his role as senior consultant at UL, Eikenberg focuses on medical device regulations in the EU and U.S., including quality management system implementations.