ISO 14155 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.
Standard 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.
ISO 14155 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 or requirements of this document could be applicable.
The main changes in the new edition are:
— inclusion of clinical quality management, risk-based monitoring and statistical considerations,
— reinforcement of risk management throughout the process of a clinical investigation,
— clarification of the applicability of the requirements of this document to the different clinical development stages.
The text of ISO 14155:2020 has been approved in Europe as EN ISO 14155:2020 without any changes and it supersedes EN ISO 14155:2011.
