ISO 14155:2026 Replaced the 2020 Edition of the Medical Device GCP Standard in March 2026

ISO 14155 specifies good clinical practice for the design, conduct, recording and reporting of clinical investigations of medical devices carried out in human subjects. According to the ISO catalogue, it can also be applied to post-market clinical studies and to investigations of software as a medical device where relevant. It does not apply to in vitro diagnostic medical devices.

The fourth edition, ISO 14155:2026, was published on 23 March 2026 and runs to 85 pages. The ISO catalogue shows the 2020 edition, as well as the earlier 2011 and 1996 editions, as withdrawn and replaced by the 2026 version. Consultancy commentaries report that the revision mainly clarifies existing requirements and aligns them more closely with a risk-based and proportionate approach, rather than introducing an entirely new framework.

ISO’s description of the edition lists strengthened requirements on residual risk, data monitoring, clinical events committees, adverse event reporting, missing data, estimands and risks arising from clinical procedures. It also lists clarifications concerning clinical performance, informed consent, eligibility criteria and the suspension of an investigation.

Industry commentaries add further detail that could not be checked against the paywalled text. They report that the standard now distinguishes between risks arising from use of the device and risks arising from clinical procedures that are not part of routine care, and makes assessment of residual risks an explicit requirement. On data monitoring, they report that the clinical investigation plan must justify the absence of a data monitoring committee, and that where a committee exists its charter must define the conditions under which the investigation may be modified, suspended or stopped for safety reasons.

Commentaries also describe a new definition and dedicated section for clinical events committees, independent groups of clinical experts set up by the sponsor to classify and assess clinical events consistently across sites. A new informative Annex K is reported to address clinical investigation design, with emphasis on estimands and intercurrent events, drawing on the framework in ICH E9(R1). Sponsors should verify these details in the published standard before relying on clause numbers quoted in secondary sources.

Under the EU Medical Device Regulation, compliance with harmonised standards published in the Official Journal gives a presumption of conformity with the corresponding requirements. Commission Implementing Decision (EU) 2026/193, adopted in early 2026, added EN ISO 14155:2020 together with its amendment A11:2024 to the list of harmonised standards; sources give dates of 28 January 2026 and 30 January 2026.

A draft Commission implementing decision dated 27 July 2026 proposes adding EN ISO 14155:2026 to the list and deferring the withdrawal of the 2020 version and its amendment. At the time of checking, adoption of that decision had not been confirmed. Sponsors relying on presumption of conformity for EU submissions should check the current Official Journal listing.

ISO has also registered a new work item, ISO/AWI 14155, approved in June 2026 and intended to replace the 2026 edition. Its scope could not be confirmed, so it should be treated as an early-stage project rather than an indication that the fourth edition is about to change.

Commentaries note that the fourth edition was published without a transition period in the ISO text. Sponsors should therefore decide how to apply it to new investigations and whether ongoing investigations need to be reassessed, taking account of the EU harmonisation position and of the expectations of other regulators and notified bodies.

Practical steps include updating clinical investigation plan templates to address residual risk and procedure-related risk, documenting the rationale for data monitoring arrangements, establishing charters and procedures for clinical events committees where they are used, and defining estimands and the handling of missing data in the statistical sections of the plan.

Manufacturers preparing clinical evidence for several markets should also consider how the revised standard interacts with regulatory requirements outside the EU, where regulators may reference ISO 14155 in guidance or accept it as a recognised standard on their own timetables. Recording in the clinical investigation plan which edition of the standard the investigation follows, and the reasons for that choice, will help notified bodies, regulators and ethics committees understand the basis on which the investigation was designed and conducted.