Need help?

EN ISO 14155:2020/A11:2024 Standard

wave
Save  

  Keywords:

#document #requirements #apply #samd #output

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Thursday 11th of June 2026

  Description:

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

  Purpose

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. NOTE1 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. NOTE2 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, whereusers of this document might consider whether specific sections and/or requirements of this document could be applicable.

  Publication

Wednesday 28th of January 2026

  Amendment

This standard is an amendment for "EN ISO 14155:2020"

  Related Standards

EN ISO 11737-1:2018

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on produ...

EN 455-3:2023

Medical devices Regulation ((EU) 2017/745)

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

EN ISO 11607-1:2020/A1:2023

Medical devices Regulation ((EU) 2017/745)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN ISO 11607-1:2020

Medical devices Regulation ((EU) 2017/745)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN ISO 11137-2:2015/A1:2023

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

EN ISO 11137-2:2015

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0