ISO 14155:2020

ISO 14155:2020 is an international standard that 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.

General requirements are specified intending to ensure the scientific conduct of the clinical investigation and reliability of the clinical investigation results while prioritizing the safety, rights, and well-being of participants. It addresses e.g., requirements for study planning and conduct, ethical considerations, risk management, data management, statistical design and analysis, and monitoring.

Responsibilities of sponsors, and investigators, are outlined. Additionally, the well-established international guideline assists ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. It is based, where appropriate, on the regulations for clinical trials of medicinal products in order to facilitate the application by institutions that test both, medicinal products and medical devices.

It applies to pre-market and post-market clinical investigations. For post-market clinical investigations, the principles set out in this document may be followed where relevant, taking into account the nature of the clinical investigation.

Adhering to ISO 14155:2020 ensures consistency across clinical investigations and facilitates that results of clinical investigations conducted in the European Union are recognized outside the EU.