Description of BS EN ISO 14155:2020 - TC 2020
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 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.
NOTEÂ 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.
NOTEÂ 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 [
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, where users of this document might consider whether
specific sections and/or requirements of this document could be
applicable.
About BSI
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