ISO releases ISO 14155:2026 worldwide; Swissmedic welcomes new standard adoption
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ISO 14155 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.
The new editionISO 14155:2026has beenmade available by ISO in English, French, and with redlines showing the changesto the previous edition. Additional language translations are currently in progress and will be published by ISO and by national standardisation organisations as they become available.
Amongst the different changes introduced in the new edition, there are updates related to safety management, including provisions for planning, ongoing safety surveillance, the assessment of safety events and measures to be taken in the event of safety issues arising during a clinical investigation. Swissmedic therefore welcomes the new standard and encourages its use.
Investigations cliniques de dispositifs médicaux