ONORM EN ISO 14155:2026

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)

This document establishes good clinical practice (GCP) for the design, conduct, recording and reporting of clinical trials of medical devices on human trial subjects to evaluate clinical performance or efficacy and safety. For post-marketing clinical follow-up, the principles set out in this document should be followed, taking into account the nature of the clinical trial, where relevant (see Annex I). This document sets out the general requirements to achieve the following: — the protection of the rights, safety and well-being of the examinees, users or other persons involved; — ensuring the scientifically correct conduct of the clinical trial and the credibility of the results of the clinical trial, — the definition of the responsibilities of the sponsor and principal investigator, — to support the work of sponsors, investigators, ethics committees, regulatory authorities and other institutions involved in the conformity assessment process for medical devices. Other standards or national requirements may be applicable to the investigational product(s) or clinical trial(s) to be assessed. NOTE: In the case of software as a medical device (SaMD), the following applies, where applicable, for the demonstration of analytical validity (the output values of the SaMD are correct for predetermined input values), scientific validity (the output values of the SaMD are associated with the intended clinical state/physiological state) and clinical performance (the output values of the SaMD are clinically meaningfully related to the intended clinical condition). Use) of the SaMD the requirements of this document, insofar as they are relevant (see [5]). As a justification for an exemption from the requirements of this document, the uniqueness of the indirect contact between the test subjects and the SaMD can be considered. This document does not apply to medical devices for in vitro diagnostics. However, depending on the product and national or regional requirements, there may be situations in which users of this document may consider whether either certain sections or requirements of this document, or both, may be applicable.