ISO/TR 24971
Guidance on the application of ISO 14971 to medical devices.
Definition
ISO/TR 24971:2020 provides guidance on developing, implementing, and maintaining a risk management system per ISO 14971, including hazard identification, risk control, residual risk evaluation, and post-production information. Because it is a technical report, it gives guidance and examples rather than requirements. Annexes cover topics such as identifying hazards and characteristics related to safety, techniques like FMEA and fault tree analysis, risk management for IVDs, and security-related risks. Much of the informative guidance that was in annexes of older editions of ISO 14971 was moved into TR 24971 in 2020.What this means in practice
TR 24971 is the de facto playbook for executing ISO 14971 in practice and is frequently referenced by auditors and notified bodies.Examples
- A MedTech manufacturer uses the guidance in ISO/TR 24971 section 6.2, 'Risk analysis techniques,' to select appropriate methodologies for identifying hazards and estimating risks for a new surgical robot.
- During a notified body audit for CE marking, a manufacturer references specific examples from ISO/TR 24971 regarding risk control measures to justify their approach to mitigating software cyber risks in their diagnostic imaging system.
- A quality manager consults ISO/TR 24971 Annex C, 'Guidance on safety-related information,' to improve their post-market surveillance process for collecting and analyzing field data relevant to risk management.
- •A common pitfall is treating ISO/TR 24971 as a standalone requirement rather than as guidance for implementing ISO 14971.
- •Manufacturers sometimes fail to periodically review and update their risk management processes based on the evolving recommendations in ISO/TR 24971.
- •Overlooking the interconnectedness between risk management activities and other quality system elements, such as design control or post-market surveillance, is a frequent mistake.
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Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1ISO/TR 24971:2020Tier 1 VerifiedISOiso.org
- 2FDA Recognized Consensus StandardsTier 2 VerifiedFDAaccessdata.fda.gov
- 3ISO Standards Catalogue - HealthTier 1 VerifiedISOiso.org
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