ISO DIS 20916

Description / Abstract: This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the safety and/or clinical performance of in vitro diagnostic (IVD) medical devices for regulatory purposes. These studies are intended to assess the ability of an IVD medical device to yield results pertaining to a particular medical condition or physiological/pathological state, in accordance with the intended population and user. The document is not intended to describe how the technical specifications of the IVD medical device in question are addressed by the clinical performance study.

This document is intended for clinical performance studies as these studies involve specimens taken from the human body. Where left over or archived specimens are not used, there might be additional collection risks for the subject. Also in interventional studies there might be a risk for the subject coming from the information provided by the result of the IVD under investigation. This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to:

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  ensure the scientific conduct of the clinical performance study will lead to reliable and robust study results;
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  define the responsibilities of the sponsor and principal investigator;
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  assist sponsors, clinical research organisations, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices; and
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  protect the rights, safety and well-being of the subjects providing specimens for use in clinical performance studies.

Analytical performance studies are out of the scope of this document. They are typically done on left over specimens or archived specimens under quality management system procedures, when the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects the contents of this document (particularly the annexes) may be useful for ensuring subject safety.

Clinical performance studies that are performed for reasons other than regulatory purposes, such as for re-imbursement purposes, are out of scope of this document, however the contents of this document may be useful for the design of such studies.

This document does not include safety information for laboratory workers or other personnel collecting the study specimens; such information is included in other standards. [1], [2], [3]

NOTE Standards developed by ISO/TC 212 are intended to be applied to IVD medical devices. Users of this document will need to consider whether other standards and/or requirements also apply to the given IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this standard and ISO 14155 may need to be considered.