Europe – IVD devices: From performance evaluation studies to clinical performance studies, what has changed?

For the marketing of in vitro diagnostic (IVD) medical devices  manufacturers need to demonstrate that their products perform as claimed, which typically requires performance data obtained from appropriate studies or from available state-of-the-art literature. These performance evaluation (PE) studies may be studies with leftover or archived samples, or be studies which can pose a risk to the participants, e.g., when sampling is primarily done for the purpose of the study.

Requirements for IVD performance evaluation studies: Current or Past?

Information on specific requirements for IVD performance evaluations, including PE studies, were quite limited in previous European Union guidance documents and standards:

For example, Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (IVDD) does not include a definition for PE studies. These studies are, however, indirectly addressed by the definition given for  devices for performance evaluation, which indicates that PE studies include “studies in laboratories or medical analyses or studies in other appropriate environments outside the own premises of the IVD medical device manufacturer.” That’s why these PE studies often are called “external” PE studies…