Standards Development

Scope

This document specifies, principles and a process for the clinical evaluation of medical devices. This document specifies how to plan and perform clinical evaluation, including the collection, appraisal and analysis of data to assess the safety and, clinical performance or effectiveness, including clinical benefit(s) of medical devices, and to evaluate the acceptability of clinical risks when weighed against the clinical benefits achieved when the device under evaluation (DUE) is used as intended by the manufacturer. This includes the determination whether there is evidence for the assessment.

This document also:

— defines the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation on behalf of the manufacturer,

— assists manufacturers, regulatory authorities and other stakeholders involved in the process or assessment of the clinical evaluation of medical devices and,

— provides guidance on the scientific conduct of a clinical evaluation, thereby supporting the credibility of conclusions.

This document does not apply to in vitro diagnostic medical devices.

NOTE 1 National regulations can have additional or different requirements.

NOTE 2 Some of the principles of this document can apply to actors other than manufacturers involved in clinical evidence generation.