Overview
ISO/TR 24971:2020 - "Medical devices - Guidance on the application of ISO 14971" - is a technical report that provides practical guidance for developing, implementing and maintaining a medical device risk management system in accordance with ISO 14971:2019. Published jointly by ISO and IEC, this guidance aligns clause-by-clause with ISO 14971:2019 and includes informative annexes covering device types, security, in vitro diagnostics, and the role of standards.
Key technical topics and requirements
ISO/TR 24971:2020 expands on the risk-management lifecycle required by ISO 14971 and offers actionable clarification on topics including:
- Risk management system structure - roles, top management commitment, competence of personnel, and documentation (risk management plan and risk management file).
- Risk analysis - identification of intended use, reasonably foreseeable misuse, characteristics related to safety, hazards and hazardous situations (including faults, random and systematic failures, and security vulnerabilities).
- Risk estimation and evaluation - guidance on estimating probability and severity, handling risks where probability cannot be estimated, and criteria for acceptability.
- Risk control - hierarchies of risk control options for design and manufacturing, implementation, verification of controls, and assessment of risks introduced by controls.
- Benefit–risk analysis and overall residual risk - methods and inputs for weighing residual risks against device benefits and determining acceptability.
- Production and post‑production activities - information collection, review, and corrective actions in post-market surveillance.
- Informative annexes - practical techniques for analysis, guidance for IVDs (Annex H), security-related risks (Annex F), use of standards in risk management (Annex E), and communication of residual risk.
Practical applications and target users
ISO/TR 24971:2020 is intended for organizations involved in medical device lifecycle activities who need to apply ISO 14971:2019 in practice. Typical users include:
- Quality and regulatory affairs professionals preparing risk documentation for conformity and submissions
- Design and development engineers implementing risk controls
- Risk managers and safety engineers conducting hazard analysis and benefit–risk assessments
- Manufacturing and production teams integrating risk control into processes
- Clinical and IVD teams using Annex H guidance for diagnostic devices
This guidance supports integration of the risk management process with quality management systems such as ISO 13485:2016, and helps meet regulatory expectations for robust risk management and post‑market surveillance.
Related standards and references
- ISO 14971:2019 - Application of risk management to medical devices (normative reference)
- ISO 13485:2016 - Medical devices - Quality management systems (related requirements for product realization and monitoring)
- ISO Handbook and informative annexes referenced within ISO/TR 24971 for further practical guidance
Keywords: ISO TR 24971:2020, ISO 14971, medical device risk management, ISO 13485, risk analysis, risk control, residual risk, benefit-risk analysis, post-market surveillance.
