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DIN Standards Committee Optics and Precision Mechanics

Abstract

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 AnnexI). 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. 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. This document amends EN ISO 14155:2020 with a revised European Foreword and the European Annex ZA, Relationship between this European standard and the requirements of Regulation (EU) 2017/745 aimed to be covered.

Begin

2023-01-03

WI

00206108

Planned document number

DIN EN ISO 14155/A11

Project number

02703391

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