Clinical investigation of medical devices for human subjects

ISO/DIS 14155 - Clinical investigation of medical devices for human subjects — Good clinical practice” is currently under preparation for its final publication and will replace the second edition of the standard ISO 14155:2011.

The ISO/DIS 14155 will include guidance on clinical quality management, statistical considerations, and clinical investigation audits, as well as a specific guidance for ethics committees.

Furthermore, this version makes mention to the risk-based monitoring, registration of the clinical investigation in a publicly accessible database, while reinforcing the aspect of risk management throughout the process of a clinical investigation. It also clarifies its applicability to different clinical development stages. The standard lays out the principles to be followed when designing, conducting, recording and reporting pre-market and post-market clinical investigations carried out in human subjects, for the assessment of the clinical performance and safety of medical devices.

The requirements intend 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 standard is not applicable to in vitro diagnostic medical devices.

Under the Medical Devices Regulation, clinical evaluation, which may involve the need to perform clinical investigations, is a requirement for devices of all classes, hence the aforementioned standard may be applicable to your devices.


Ana Rita Falcão

RA&QA Department

05.02.2020


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