ISO 20916:2019

Overview

ISO 20916:2019 - "In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice" provides a structured framework for planning, designing, conducting, recording and reporting clinical performance studies of in vitro diagnostic (IVD) devices for regulatory purposes. It defines principles and general requirements to ensure reliable, robust study results while protecting the rights, safety and well‑being of human subjects who provide specimens. Note: analytical performance studies and studies for non‑regulatory purposes (e.g., reimbursement-only studies) are out of scope.

Key topics and requirements

ISO 20916:2019 covers practical and procedural elements for IVD clinical performance studies, including:

• Ethical considerations: informed consent, ethics committee involvement, avoiding improper influence.
• Study planning and risk evaluation: study design, risk assessment when specimens are collected specifically for the study.
• Clinical Performance Study Protocol (CPSP): required contents, principal investigator responsibilities and protocol structure.
• Investigator brochure and case report forms: content and use to support study conduct.
• Specimen handling: recording specimen information, specimen accountability, integrity and labelling.
• Site management: site qualification, selection, initiation, training and monitoring plans.
• Sponsor and investigator responsibilities: duties for study conduct, monitoring and documentation.
• Data protection and security: confidentiality and recordkeeping.
• Study close‑out and reporting: clinical performance study report, document retention, suspension/termination procedures.
• Auditing and adverse event categorization: processes to ensure compliance and subject safety.
• Annexes: normative annexes provide templates and additional requirements (CPSP, investigator brochure, informed consent, study report, adverse event categorization); informative annexes address documentation and auditing.

Special provisions are included for interventional studies or when specimen collection poses additional risks; these are detailed in specific annexes.

Practical applications and users

ISO 20916:2019 is intended for organizations and professionals involved in IVD clinical performance studies, including:

• IVD device manufacturers and sponsors preparing regulatory submissions.
• Clinical research organizations (CROs) managing study conduct and monitoring.
• Principal investigators and clinical sites implementing study protocols and specimen handling.
• Ethics committees and regulatory authorities reviewing study plans and reports.
• Quality and regulatory affairs teams ensuring conformity with good study practice.

Use cases: designing study protocols, preparing investigator brochures and informed consent forms, establishing specimen chain‑of‑custody, developing monitoring plans, and compiling clinical performance study reports for regulatory review.

Related standards

• ISO 14155 (clinical investigation of medical devices) may be relevant when an IVD is part of an integrated system (e.g., lancet + strip + meter); jurisdictions determine applicability.
• Analytical performance studies are excluded from ISO 20916 and are addressed by other guidance and standards.

Keywords: ISO 20916:2019, in vitro diagnostic, IVD clinical performance studies, good study practice, CPSP, investigator brochure, specimen integrity, regulatory compliance.