The latest edition of ISO 14155 2026, the international Good Clinical Practice standard for medical device clinical investigations, was published Spring 2026. ISO 14155:2026 replaces the 2020 version and there is no defined transition period, so organisations must act now to ensure compliance.
The updated ISO 14155:2026 standard for Good Clinical Practice (GCP) in medical device clinical investigations introduces several important changes affecting the designing the investigation, risk management, safety reporting and oversight of clinical investigations. While the overall structure remains familiar, the revised standard places greater emphasis on risk management, subject protection, statistical methodology and investigation governance. Many of the updates also bring ISO 14155 into closer alignment with the EU Medical Device Regulation (MDR) and modern clinical research practices like decentralised trials.
In this article, we highlight the most significant changes introduced in ISO 14155:2026 and what they mean for sponsors, manufacturers, CROs and investigators.
What is ISO 14155:2026?
ISO 14155 is the internationally recognised standard for the design, conduct, recording and reporting of clinical investigations involving medical devices.
The standard provides the framework for demonstrating the safety, performance and clinical benefit of medical devices while protecting the rights, safety and well-being of study participants. For manufacturers seeking MDR compliance, ISO 14155 plays a central role in generating clinical evidence that supports conformity assessment and market access.
How has the definition of clinical performance changed?
The revised standard introduces a new definition of clinical performance. Previously, the focus was largely on device behaviour and patient response. ISO 14155:2026 shifts the emphasis towards demonstrating that the device achieves its intended purpose and delivers a clinical benefit.
This change has practical implications for study design and defining the appropriate estimands for a clinical benefit.
Clinical investigations should now be planned to demonstrate meaningful clinical benefit rather than merely measuring technical performance or functional outcomes. Endpoint selection therefore becomes increasingly important, particularly in pivotal investigations supporting MDR submissions.
Free webinar: Medical device clinical evaluation
In this webinar you will learn if your medical device is in a need of clinical investigations. You will also learn about properly documenting a clinical evaluation, including how to compile a clinical evaluation plan and a clinical evaluation report according to the requirements in the MDR. In the webinar we will also give practical tips for ensuring that your clinical investigation meets the needed GCP requirements and none of the essential elements are forgotten.
What are the key changes in ISO 14155:2026?
The most notable update is the complete restructuring of the risk management framework. In ISO 14155:2020, clinical investigation risks were largely managed within a single framework. The new version separates risks into three distinct categories, each requiring its own assessment and management approach:
1. Risks related to the investigational device
These include risks associated with:
- the investigational device itself
- its technology and design
- instructions for use (IFU)
- clinical application procedures
These risks continue to be managed according to ISO 14971. The view presently is that residual risk assessments must be proportionate to the planned study population and sample size. Larger investigations may therefore require more extensive risk documentation and justification.
2. Risks related to study-specific procedures
ISO 14155:2026 introduces a separate category for risks arising from clinical investigation procedures that fall outside routine clinical practice. Examples include:
- additional biopsies
- extra imaging procedures
- extended washout periods
- additional blood sampling
These procedure-related risks now require their own assessment and monitoring pathway rather than being combined with device-related risks.
3. Risks related to the investigation process
The third category covers risks associated with the conduct of the investigation itself, such as:
- data collection processes
- monitoring activities
- randomisation procedures
- data management systems
Although these risks existed previously, ISO 14155:2026 now explicitly identifies them as a separate risk category.
As a result, sponsors may need to update risk management plans, safety monitoring procedures and escalation processes to reflect this three-tier risk framework. Clinical Investigation Plans (CIPs) and risk management files will require more detailed linkage and justification.
How does ISO 14155:2026 affect statistical design?
One of the most important methodological updates is the alignment with ICH E9(R1). The revised standard introduces concepts such as:
- estimands
- intercurrent events
- predefined endpoint strategies
- missing data handling approaches
For sponsors conducting pivotal investigations, statistical planning will require more detailed justification and documentation than before.
Concept of Clinical Events Committees (CECs)
ISO 14155:2026 formally introduces the Clinical Events Committee (CEC). A CEC is an independent committee of clinical experts responsible for ensuring consistent assessment and classification of clinical events across study sites.
Sponsors are expected to consider whether a CEC is needed before initiating an investigation. If a CEC is not established, the decision should be justified within the Clinical Investigation Plan. This change is particularly relevant for:
- multicentre investigations
- complex clinical studies
- studies involving subjective endpoint assessment
How to manage eligibility criteria changes and protocol deviations?
Now ISO 14155:2026 explicitly states that deviations from eligibility criteria are not permitted. If inclusion or exclusion criteria need to be modified during a clinical investigation, a formal amendment to the Clinical Investigation Plan (CIP) is required.
This removes previous ambiguities and reinforces the importance of robust study planning before recruitment begins. As to protocol deviation in general monitoring plans and deviation management procedures will need closer alignment.
What updates have been made to informed consent?
Several updates strengthen participant protection and documentation requirements.
Greater clarity regarding legally designated representatives
The revised wording clarifies that consent from a legally designated representative should only be used where applicable, meaning investigators must assess and document a participant’s capacity to consent before relying on a representative.
Opportunity to discuss participation with others
As per GCP participants must now be given the opportunity to discuss participation with family members or others before providing consent. This is nothing new, but it is reminded that this process need to be documented.
GCP for medical devices also emphasizes communication of relevant information during the investigation and following that consent templates or procedures may require review and updates.
What has changed in adverse event reporting?
The updated standard introduces greater flexibility while also increasing clarity.
Reduced adverse event reporting may be possible
For certain lower-risk investigations, such as some Post-market Clinical Follow-up (PMCF) studies, reduced adverse event recording or reporting may be allowed. However:
- the approach must be justified in the CIP
- ethics committee approval is required
- regulatory approval may also be necessary
Device deficiencies and adverse events must be linked
Where an adverse event is associated with a device deficiency, both reporting pathways must now be applied. This strengthens traceability and ensures a more comprehensive evaluation of safety signals.
What are the new aspects concerning temporary halt or stopping an investigation?
This provides sponsors with greater flexibility while maintaining participant protection. Sponsors are expected to define criteria under which a study may be modified, paused, or stopped upon decision of Data Monitoring Committee. ISO 14155:2026 introduces a more nuanced approach to suspension decisions.
The actions taken now depend on whether the concern relates to:
- device-use risks, or
- procedure-related risks
The standard also introduces the concept of partial suspension or halt. For example, recruitment may be paused while already enrolled participants continue follow-up activities if this is considered beneficial and safe.
What other practical changes should sponsors be aware of?
Several operational updates have also been introduced.
Implant cards for implantable devices
Sponsors conducting investigations involving implantable devices should ensure implant cards are prepared and incorporated into study planning. This isn’t a new obligation — implant cards have been an MDR requirement since Article 18 came into effect in 2021, with detailed guidance already available in MDCG 2019-8 and MDCG 2021-11. What ISO 14155:2026 does is make this MDR duty more explicit within the clinical investigation context, so sponsors should ensure their CIPs and study documentation clearly reference and integrate the existing implant card process, rather than treating it as a new deliverable.
Equipment calibration requirements
Clinical Investigation Plans should now identify relevant equipment and describe maintenance and calibration arrangements. Monitors are expected to verify calibration records during monitoring visits.
Adapting to ISO 14155:2026
Although many principles remain unchanged, ISO 14155:2026 introduces several important requirements that may affect clinical investigation documentation, governance, risk management processes and study design.
Organisations planning medical device clinical investigations should review and update:
- Clinical investigation plans (CIPs)
- Risk management procedures
- Informed consent form (ICF)
- Investigator’s brochures (IB)
- Safety reporting processes
- Oversight committee charters
- Statistical analysis plans (SAP)
Careful planning can help avoid delays and support a smooth transition to the updated standard.
Need support with medical device clinical investigations?
Medfiles supports manufacturers throughout the clinical investigation lifecycle, from study planning and regulatory strategy to clinical operations, monitoring, medical writing and MDR clinical evidence generation.
Whether you are preparing for ISO 14155:2026 or planning a new medical device clinical investigation, our experts can help ensure your study is designed and conducted in line with current regulatory and GCP expectations.
Author: Essi Sarkkinen, Director, Clinical Research and Medical Device
Since joining Medfiles in 2014, Essi Sarkkinen has held several leadership positions. She led the Food, Feed, and Medical Device Regulatory Unit, and later the Clinical Unit. In March 2025, she was appointed Director of Clinical Research and Medical Device.
Essi has a PhD in clinical nutrition and she is adjunct professor at the University of Eastern Finland. Essi has published dozens of scientific articles in peer-reviewed journals and supervised four academic dissertations. After her academic career, she has worked for over 15 years managing and leading contract research in the field of food and nutrition. In the beginning of the 2000s, Essi started working with clinical trials for medicinal products and good clinical practice (GCP), as well as regulatory affairs concerning food product, like health claims and novel foods.
Essi has over 30 years of experience in clinical trials and medical writing as well as know-how of R&D and regulatory affairs in the fields of food, medical devices and pharmaceuticals. All in all, she has worked in various leadership positions in contract research organisations for over 25 years.
See also:
- Free webinar: Medical device clinical evaluation – how to document it under the MDR and how to prepare for a clinical investigation?
- When does your medical device need a clinical investigation?
- Guide: How to meet MDR Good Clinical Practice requirements in practice?
- WellO2 & Medfiles: collaboration ensured success of the clinical study
