Regulatory Context
The ISO 14155 standard is the international framework governing clinical investigations of medical devices in humans, in accordance with the principles of Good Clinical Practice (GCP).
The publication of ISO 14155:2026 comes amid a more stringent regulatory environment, marked in particular by the implementation of Regulation (EU) 2017/745 (MDR). This revision aims to improve the scientific quality of clinical studies, strengthen the protection of participants, and further structure the governance of clinical investigations.
Significantly stricter methodological requirements
Version 2026 introduces stricter requirements for the design of clinical trials.
The Clinical Investigation Plan (CIP) becomes the central document, with a greater emphasis on consistency between:
- the objectives of the study,
- the assumptions,
- the evaluation criteria,
- and the study population.
Methodological aspects are more clearly defined, in particular:
- assessment methods,
- data management,
- statistical analyses,
- the study timeline.
In addition, the standard introduces the concept of an “estimand,” which allows for a more precise definition of the effect to be measured by taking into account missing data and intercurrent events.
A Structured Approach to Risk Management
The standard now clarifies and distinguishes between three categories of risk:
- the risks associated with the device,
- risks associated with investigative procedures,
- the risks associated with conducting the study itself.
The concept of standard clinical practice is becoming a key benchmark for identifying additional risks.
This development requires manufacturers to conduct a risk analysis specific to clinical investigations, incorporating:
- the target population,
- the indication,
- and the size of the study.
Stricter Ethical Requirements
Protection for participants has been significantly strengthened in the 2026 version. Informed consent is evolving into a more structured process, ensuring:
- a genuine understanding of the subject,
- sufficient time to think it over,
- the opportunity to talk with loved ones,
- and, if necessary, the involvement of a legal representative.
The standard also recognizes the use of electronic consent (eConsent) and enhances transparency regarding the use of data, including in the event of a participant’s withdrawal.
Stronger academic governance
Version 2026 introduces a more structured approach to the governance of clinical investigations.
The role of independent committees is clarified, specifically:
- the Data Monitoring Committee (DMC) for safety monitoring,
- the Clinical Event Committee (CEC) for the classification of clinical events.
Although they are not implemented across the board, their absence must now be justified.
The standard also introduces:
- more flexible procedures for managing adverse events,
- a phased approach to managing high-risk situations (with the possibility of partial suspension),
- clarification of the conditions for taking a break from and resuming studies.
Greater Responsibilities for Stakeholders
The responsibilities of stakeholders are changing:
- The developer’s role is being strengthened, particularly with regard to governance, committee independence, and the development of specific measures (e.g., site plan).
- The investigator focuses his or her reporting obligations on serious adverse events related to the device.
A growing need for consistency and transparency
The standard requires greater consistency in documentation between:
- the investigator’s brochure,
- the instructions for use,
- the CIP,
- and the consent forms.
It also requires an explicit justification of methodological choices, particularly regarding:
- missing data,
- statistical analyses,
- and concurrent events.
Impacts on Medical Device Manufacturers
The ISO 14155:2026 standard brings about significant changes for manufacturers:
- A strengthening of the strategic role of the clinical investigation plan, which becomes the cornerstone of clinical validation.
- A risk management approach specific to the investigation, distinct from that of the system.
- Greater formalization of academic governance, with requirements regarding committees and decision-making.
- High standards for scientific quality, requiring greater foresight from the very outset of study design.
- Greater protection for participants, with more structured monitoring and enhanced transparency.
These developments reflect a clear alignment with the requirements of the MDR and confirm the central role of clinical investigations in demonstrating the safety and performance of medical devices.
👉 Isocèle Conseil helps you prepare for your clinical trials.