ISO 14155 is not simply a documentation standard. It is a framework for protecting participants and producing clinical investigation results that sponsors, investigators, ethics committees, and regulators can trust.
For a medical device sponsor, ISO 14155 becomes practical when it is used to shape how the investigation is designed and run—not when it is treated as a checklist assembled shortly before an audit or submission.
The current edition is ISO 14155:2026, published in March 2026. It replaced ISO 14155:2020. The standard specifies good clinical practice for the design, conduct, recording, and reporting of clinical investigations in human participants that assess the clinical performance or effectiveness and safety of medical devices. Other national, regional, and product-specific requirements can also apply.
What ISO 14155 is designed to achieve
The standard is built around four connected outcomes: protecting the rights, safety, and well-being of participants and other affected people; maintaining scientific conduct; producing credible investigation results; and defining the responsibilities of the sponsor and principal investigator.
That makes ISO 14155 both an ethical framework and an evidence-quality framework. Participant protection, protocol clarity, risk management, monitoring, safety reporting, data integrity, and sponsor governance are not separate workstreams. They reinforce one another.
Start with applicability and the current edition
Before using an existing template or quality plan, confirm which edition and jurisdiction-specific requirements apply to the investigation. ISO 14155:2026 does not apply to in vitro diagnostic medical devices as a general rule, although specific parts may be considered where a jurisdiction or study context makes them relevant. Software as a Medical Device can also require a tailored assessment of which requirements apply.
A sponsor planning multi-country work should map the standard against local ethics, regulatory, privacy, safety-reporting, and device-accountability requirements. Compliance with one framework does not automatically satisfy every market.
Five practical pillars for sponsors
1. Connect clinical risk to the investigation design
The clinical investigation should be informed by the device's risk management, intended purpose, clinical evaluation, known hazards, and remaining evidence gaps. Device-specific risks may involve procedure variability, user technique, learning effects, software behaviour, migration, overheating, component failure, or use error. Those risks should influence endpoints, eligibility, training, monitoring, safety definitions, and escalation pathways.
2. Make the clinical investigation plan operational
A scientifically sound protocol can still fail operationally if sites must repeatedly interpret what the sponsor intended. The clinical investigation plan should clearly define the population, intervention, device version, training, endpoints, assessments, safety events, device deficiencies, deviations, data collection, follow-up, and decision rules. Supporting documents should tell the same story.
3. Build sponsor oversight that produces evidence
Sponsors can delegate activities to CROs, laboratories, imaging providers, data vendors, and other partners, but they still need an effective governance model. That means clear responsibilities, documented qualification and oversight, useful performance and quality indicators, issue escalation, review cadence, decision records, and follow-through. Meetings alone do not demonstrate control.
4. Treat informed consent and safety workflows as living processes
Consent is more than a signed form. Sponsors need a controlled process for clear participant information, approval and version management, site training, consent before study-specific procedures, and re-consent when new information makes it necessary. Safety processes should define events and device deficiencies consistently, establish reporting and escalation timelines, and connect clinical operations with risk management and complaint handling.
5. Design data quality into the workflow
Data credibility depends on collectable endpoints, consistent source documentation, traceable changes, reviewable records, controlled systems, and timely resolution of discrepancies. Monitoring should be proportionate to the risks and critical data, not reduced to a universal source-data-verification percentage.
Common implementation failures
- Treating ISO 14155 as the CRO's responsibility instead of establishing sponsor-side governance.
- Using a pharmaceutical protocol template without accounting for device iteration, operator learning, procedure variability, or device deficiencies.
- Keeping the clinical investigation separate from the quality management system, risk management, change control, training, and complaint handling.
- Choosing endpoints that do not align with the intended purpose, clinical claims, or important device risks.
- Defining safety events differently across the protocol, monitoring plan, database, and site training.
- Waiting until database lock or an inspection to discover that source, data-flow, and oversight expectations were unclear.
A sponsor readiness check
- Have we confirmed the current applicable standard, local requirements, and device-specific guidance?
- Can we trace important clinical risks into the protocol, monitoring, training, safety, and data plans?
- Do the protocol and supporting documents form one coherent operating model?
- Are delegated responsibilities, oversight activities, escalation routes, and decisions documented?
- Can sites apply eligibility, endpoints, device-use, and safety definitions consistently?
- Are consent, re-consent, device accountability, deviations, and deficiencies controlled from the start?
- Will the resulting records show what happened, why decisions were made, and whether the evidence is credible?
The value is trustworthy evidence—not paperwork
A well-designed ISO 14155-aligned investigation is easier to explain, oversee, monitor, and defend because its risks, responsibilities, data, and decisions are connected. That can reduce avoidable rework while giving ethics committees, regulators, clinicians, and sponsors greater confidence in the evidence.
Mobius helps medical device sponsors translate good clinical practice into workable clinical investigation plans, site and vendor models, monitoring strategies, safety workflows, data-quality controls, and sponsor oversight across Australia, New Zealand, and the United States.
This article provides general clinical development information and is not regulatory, legal, quality-system, or medical advice. Obtain the current standard and confirm applicable requirements for the device, investigation, and jurisdictions involved.
References
- ISO 14155:2026—Clinical investigation of medical devices for human subjects—Good clinical practice — International Organization for Standardization
- Acceptance of Data from Clinical Investigations for Medical Devices — U.S. Food and Drug Administration
- Clinical evidence guidelines for medical devices — Therapeutic Goods Administration
- Regulation (EU) 2017/745 on medical devices — EUR-Lex