ISO 14155:2020 — Clinical investigation of medical devices for human subjects — Good clinical practice

Specifies good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices. ISO 14155 covers ethical considerations, clinical investigation planning, site management, monitoring, adverse event reporting, and statistical considerations. Harmonized under the EU MDR and recognized internationally.

Standard Details

• Standard Number: ISO 14155:2020
• Type: ISO Standard
• Published by: ISO
• Official Link: https://www.iso.org/standard/71690.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.