ISO Publishes ISO 14155:2026 on Good Clinical Practice for Medical Device Clinical Investigations
The International Organization for Standardization has published ISO 14155:2026, titled “Clinical investigation of medical devices for human subjects — Good clinical practice.”
The new edition was published in March 2026 and is listed as Edition 4 of the standard.
Purpose of ISO 14155:2026
ISO 14155:2026 specifies good clinical practice for the design, conduct, recording and reporting of clinical investigations involving human subjects.
The standard applies to clinical investigations carried out to assess the clinical performance or effectiveness and safety of medical devices.
Key Objectives
According to ISO, the standard sets out general requirements intended to:
protect the rights, safety and well-being of human subjects, users and other persons;
ensure the scientific conduct of clinical investigations;
support the credibility of clinical investigation results;
define the responsibilities of sponsors and principal investigators;
assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in conformity assessment.
Post-Market Clinical Investigations
For post-market clinical investigations, ISO notes that the principles of the standard are intended to be followed as far as relevant, considering the nature of the clinical investigation.
This makes the standard relevant not only for pre-market clinical evidence generation, but also for post-market clinical activities where clinical investigation principles remain applicable.
Software as a Medical Device
The ISO page also includes a note on Software as a Medical Device.
Where appropriate, the standard may be relevant to the demonstration of analytical validity, scientific validity and clinical performance of SaMD, considering the specific nature of software and the indirect contact between subjects and the device.
Scope Limitations
ISO states that the document does not apply to in vitro diagnostic medical devices.
However, depending on the device and applicable national or regional requirements, users may consider whether specific sections or requirements of the standard could be applicable.
Impact on Medical Device Manufacturers
For medical device manufacturers, sponsors and clinical investigation teams, ISO 14155:2026 is an important reference for planning and conducting clinical investigations involving human subjects.
Manufacturers should pay particular attention to:
clinical investigation design;
sponsor and principal investigator responsibilities;
protection of subjects’ rights, safety and well-being;
clinical performance and safety assessment;
scientific conduct and data credibility;
clinical investigation recording and reporting;
post-market clinical investigation relevance;
applicability to Software as a Medical Device;
alignment with regulatory and conformity assessment expectations.
For manufacturers generating clinical evidence, the publication of ISO 14155:2026 reinforces the importance of structured, ethical and scientifically robust clinical investigation processes.
