NF EN ISO 20916, S92-082 (03/2024)

This document defines good practices for the planning, design, conduct, recording and reporting of clinical performance studies conducted to evaluate the clinical performance and safety of diagnostic medical devices in vitro (IVD) for regulatory purposes. NOTE 1 These studies aim to evaluate the capacity of an IVD medical device, made available to the user concerned, to produce results specific to a particular condition or to a particular physiological/pathological state, within the population concerned. The document is not intended to describe whether or not the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. This document identifies the principles supporting clinical performance studies and specifies general requirements to — ensure that the conduct of the clinical performance study will yield reliable and robust study results, — define the responsibilities of the sponsor and the principal investigator, — assist sponsors, clinical research organizations, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and — protect the rights, the safety, dignity and well-being of subjects providing samples for use in clinical performance studies. Analytical performance studies are not within the scope of this document. NOTE 2 When the collection of samples specific to the study of analytical performance creates an additional collection risk for subjects, some of the elements of this document (in particular the annexes) may be useful to ensure the safety of the subject. Clinical performance studies conducted for purposes other than pre- and post-marketing regulatory purposes, particularly in the context of a reimbursement request, are outside the scope of this document. NOTE 3 Some of the elements in this document may be useful in designing these studies, including subject safety and data integrity. This document does not include safety information for laboratory personnel or other personnel collecting study samples. NOTE 4 This information appears in other publications[1][12][13]. NOTE 5 Users of this document may take into account that other standards and/or requirements also apply to the IVD medical device that is the subject of the clinical performance study; for example, if an IVD medical device and a medical device are used in an integrated system (e.g. a lancet, an IVD test strip and a glucometer), aspects of this document and ISO 14155 may be considered .
(Automatic translation from French)