Upcoming Changes to ISO 14155:2020ISO 14155:2020, the international standard for the clinical investigation of medical devices for human subjects, is undergoing significant updates. These changes are designed to enhance risk management, clarify procedures and ensure the safety and efficacy of clinical trials.
Here’s a summary of the key updates:
Risk Management Updates:
1. Risks related to investigational devices (6.2.1)
- New considerations focus on the specific risks associated with using the investigational device itself. These include adjustments in risk acceptability criteria based on the study population proportion and the updated risk management flow both before and after the start of the study.
2. Risks related to clinical investigations (6.2.2)
- This section now includes risks associated with procedures required by the Clinical Investigation Plan (CIP) that fall outside standard care. A new section (7.4.5) mandates a risk-based approach to managing these additional clinical procedures, advising sponsors to consider suspending or terminating the study if unacceptable risks arise.
Adverse Event (AE) Categorization
Annex F has been updated to improve the categorization of adverse events (AEs). This includes clear criteria for identifying and classifying serious adverse device effects (SADE), anticipated SADEs, and non-device-related AEs. The flowchart in Annex F has been revised to provide more precise guidance on the categorization process.
Estimands Framework
A new Annex K introduces the concept of “estimands” for clinical investigation design. An estimand is a precise description of the treatment effect that reflects the clinical question posed by the investigation’s objective. This framework helps in aligning the statistical analysis with the clinical objectives, considering factors such as treatment conditions, target population, endpoints, intercurrent events and methods for handling missing data.
Informed Consent
Updates to sections 5.8.1 and 5.8.2 emphasize the importance of obtaining written informed consent from subjects or their legally designated representatives before any clinical investigation procedures are applied. The process must be thoroughly documented, and any special circumstances must be clearly described.
Investigator Brochure
The information required in the Investigator Brochure has been expanded, ensuring comprehensive details about the investigational device are provided. This includes all relevant technical, functional, and clinical performance characteristics.
