Standards Development

Scope

This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see AnnexI).

This document specifies general requirements intended to

—protect the rights, safety and well-being of human subjects,

—ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,

—define the responsibilities of the sponsor and principal investigator, and

—assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

NOTE1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.

NOTE2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD’s output is accurate for a given input), and where appropriate, the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference[4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.

This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, whereusers of this document might consider whether specific sections and/or requirements of this document could be applicable.

Purpose

The 2020 version of the standard is harmonised under the European Directive 93/42/EEC (MDD_93) pertaining to medical devices as well as under the Directive 90/385/EEC relating to active implantable medical devices. The Directives have been replaced by the Regulation covering medical devices (MDR (EU) 2017/745). The European Amendment will add a new Annex ZA for harmonization of the standard to the MDR.

For an assessment of this Annex ZA to take place, CEN/TC 206 needs to include a European Amendment A11 to this standard in its work programme.