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 Annex I).
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
— 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.
NOTE 1 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.
NOTE 2 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 ). 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, where users of this document might
consider whether specific sections and/or requirements of this document could be applicable.