BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice

BS EN ISO 14155:2020 - TC

Tracked Changes. Clinical investigation of medical devices for human subjects. Good clinical practice

Status : Withdrawn   Published : August 2020


What is BS EN ISO 14155:2020 about?

This international standard sets out good clinical practice for conducting medical device clinical investigations using people. BS EN ISO 14155:2020 wants to protect people’s rights, safety and well-being, and ensure the credibility of results.

Who is BS EN ISO 14155:2020 for?

  • Clinicians conducting clinical trials with medical devices
  • Clinical research professionals (e.g. clinical research associates, clinical project managers)
  • Medical device manufacturers sponsoring clinical trials
  • Regulatory bodies (regulatory agencies, Notified Bodies)
  • Ethics committees
  • Clinical research organizations

Why should you use BS EN ISO 14155:2020?

This standard deals with good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out on human subjects to assess the safety or performance of medical devices for regulatory purposes. It provides a way to verify the quality and fitness for purpose of clinical data obtained for regulatory purposes.

The principles set out in BS EN ISO 14155:2020 also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations.

The 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
  • Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices

This third edition includes clarifications and expansions that will ensure greater compliance with regulatory requirements. These will better meet user needs, improve patient safety, speed up the route to market and provide greater confidence in the regulatory compliance of marketed products.

BS EN ISO 14155:2020 contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages. This goal will be supported by the provision of quality healthcare, effective medical equipment and safe clinical practice which is what this standard helps promote.

What’s new about BS EN ISO 14155:2020?

There have been a number of developments since the 2011 publication of the second edition that necessitated an update. Drivers included the more stringent requirements for clinical data in the European Medical Devices Regulation. Also there was a need to ensure greater consistency with new guidelines on good clinical practice for pharmaceuticals. BS EN ISO 14155:2020 therefore includes additional guidance on:

  1. Risk management in the design and conduct of clinical trials
  2. Informed consent
  3. Protection of vulnerable populations
  4. Arrangements for publication, transparency and data protection.

Standard NumberBS EN ISO 14155:2020 - TC
TitleTracked Changes. Clinical investigation of medical devices for human subjects. Good clinical practice
Publication Date26 August 2020
Normative References(Required to achieve compliance to this standard)ISO 14971
Informative References(Provided for Information)ISO 13485:2016, ISO 10993 (all parts), ISO 15223-1
International RelationshipsEN ISO 14155:2020
DescriptorsPatients, Performance testing, Risk assessment, Documents, Research methods, Safety measures, People, Clinical investigation instruments, Equipment safety, Medical equipment, Clinical testing, Experimental data, Performance, Diagnosis (medical)
Title in FrenchInvestigation clinique des dispositifs médicaux pour sujets humains. Bonne pratique clinique
Title in GermanKlinische Prüfung von Medizinprodukten an Menschen. Gute klinische Praxis
ISBN978 0 539 15174 9
File Size3.926 MB

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