ISO 14155:2020 is the international standard that provides guidelines for the design, conduct, recording, and reporting of clinical investigations of medical devices involving human subjects. It aims to ensure the ethical and scientific quality of clinical trials, thereby safeguarding the rights, safety, and well-being of participants while producing credible clinical data. CITI Program+12Matrix Requirements+12ISO+12Medical Device HQ+1Greenlight Guru+1
🔍 Key Features of ISO 14155:2020
1. Ethical Considerations
The standard emphasizes adherence to ethical principles originating from the Declaration of Helsinki, ensuring that the rights, safety, and well-being of human subjects are paramount and prevail over the interests of science and society. imdrf.org
2. Clinical Investigation Plan (CIP)
A comprehensive CIP is required, detailing the rationale, objectives, design, methodology, monitoring, statistical considerations, and organization of the clinical investigation. This plan serves as a foundational document guiding the study’s execution. imdrf.org+2Emergo by UL+2Public Health+2
3. Risk Management
The standard incorporates risk management principles throughout the clinical investigation process, referencing ISO 14971 for the application of risk management to medical devices. This ensures that potential risks are identified, evaluated, and mitigated appropriately. PPD+132352161.s21i.faiusr.com+1
4. Responsibilities of Sponsors and Investigators
ISO 14155:2020 delineates the roles and responsibilities of sponsors and principal investigators, ensuring accountability and clarity in the conduct of clinical investigations. Wikipedia+5Greenlight Guru+5Greenlight Guru+5
5. Data Integrity and Documentation
The standard mandates the maintenance of accurate and complete records, ensuring the integrity and traceability of clinical data throughout the investigation.
🆕 Updates in the 2020 Revision
The 2020 edition introduces several significant updates:Wikipedia+4Matrix Requirements+4Medical Device HQ+4
- Expanded Scope: The standard now encompasses a broader range of medical devices, including in vitro diagnostic devices (IVDs) and combination products. Qmed+2Matrix Requirements+2Wikipedia+2
- Enhanced Risk Management: There is a stronger emphasis on applying risk management principles throughout the clinical investigation process. Emergo by UL+9Greenlight Guru+9Greenlight Guru+9
- Electronic Data Capture (EDC): Guidance is provided on ensuring the integrity, security, and compliance of electronic data in accordance with regulatory requirements. Matrix Requirements
- Updated Regulatory References: The standard aligns with current regulatory expectations, including the European Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). ICON plc+2Matrix Requirements+2Qmed+2
🌐 Global Recognition and Compliance
ISO 14155:2020 is recognized by regulatory authorities worldwide, including the U.S. Food and Drug Administration (FDA), which accepts clinical trials conducted in accordance with this standard, even if the data is collected outside the United States. ICON plc
For more detailed information, you can access the full text of ISO 14155:2020 on the ISO website.
