ISO 14971 (Medical Device Risk Management)

ISO 14971 is the international standard for the application of risk management to medical devices. ISO 14971:2019 (and its companion technical report ISO/TR 24971) is required by EU MDR/IVDR and harmonized for FDA acceptance; the standard governs the entire risk file from hazard identification through residual-risk evaluation and post-market surveillance.

Scope

The standard defines a risk-management process tailored to medical devices: planning, identification of hazards, estimation of risk for each hazardous situation, evaluation against acceptance criteria, implementation of risk controls in the order risk-by-design → protective measures → information for safety, residual-risk evaluation, and a post-production information loop. It explicitly forbids economic considerations from determining acceptable risk levels.

Relationships (see sidebar)

• Normative for the Risk Matrix data object and Design Controls capability.
• Companion to ISO 13485 (QMS) and EU MDR / EU IVDR.

Steward

ISO/TC 210 (Quality management and corresponding general aspects for medical devices).