The lifecycle process defined by ISO 14971 for identifying, analyzing, evaluating, controlling, and monitoring risks associated with a medical device throughout its life cycle.

Definition

Risk management, as codified in ISO 14971:2019, Application of risk management to medical devices, is a systematic process manufacturers apply throughout a device's entire life cycle. The process includes risk analysis (identifying hazards, hazardous situations, and estimating associated risk), risk evaluation (comparing estimated risk against defined acceptability criteria), risk control (implementing measures such as inherent safety by design, protective measures, and information for safety, then verifying their effectiveness and evaluating any residual and newly introduced risks), overall residual risk evaluation and benefit-risk analysis, and collection and review of production and post-production information to confirm the risk management file remains valid. The output is a risk management file that a manufacturer must maintain and update throughout the device's commercial life.

Why it matters

Risk management is not a one-time design activity; ISO 14971 explicitly requires manufacturers to establish a system for actively collecting and reviewing production and post-production information (complaints, field data, literature, PMS/vigilance data) and feeding it back into the risk management file. Under MDR Article 10(2) and Annex I Section 3, and the equivalent IVDR provisions, risk management is a mandatory GSPR obligation, not merely good practice, and its output is reviewed by notified bodies as part of technical documentation assessment.

Common pitfalls

•Treating risk management as a design-phase-only activity and failing to actively update the risk management file with post-market surveillance data.
•Setting risk acceptability criteria after the fact to justify an already-designed device, rather than defining criteria upfront per the ISO 14971 process.
•Conflating risk management with usability engineering or software lifecycle processes instead of properly interfacing them as ISO 14971, IEC 62366-1, and IEC 62304 each require.

Sources

ISO 14971:2019 · ISO
Regulation (EU) 2017/745, Annex I Section 3 · EUR-Lex
ISO 13485 Standard Page · ISO

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