Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026); German version EN ISO 14155:2026
Abstract
This document specifies good clinical practice (GCP) 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 the general requirements intended to — protect the rights, safety and well-being of human subjects, users or other persons, — 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. Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s). 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 can consider whether either specific sections or requirements of this document, or both, can be applicable.
Begin
2024-05-28
WI
00206095
Planned document number
DIN EN ISO 14155
Project number
02703437
Responsible national committee
NA 027-07-20 AA - Clinical investigation
Responsible european committee
CEN/TC 206 - Biological and clinical evaluation of medical devices
Responsible international committee
ISO/TC 194/WG 4 - Clinical investigation and evaluation of medical devices in humans
draft standard
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
2024-09
Order from DIN Media
