Icologiq Knowledge · Standard
ISO 14971
The international standard defining a systematic process for identifying, evaluating, controlling and monitoring risks associated with medical devices throughout their lifecycle.
ISO 14971
Also known as:
ISO 14971:2019, medical device risk management
At a glance
Type
Standard
Topic
MedTech
Applies to
MedTech & Medical Devices
Current version
ISO 14971:2019
Status
Current edition; confirmed in 2025
Last reviewed
October 9, 2026
Definition
ISO 14971 describes a structured risk-management process for medical devices, including risk analysis, evaluation, control, assessment of residual risk, production and post-production information, and ongoing review.
Why it matters
ISO 14971 matters because medical-device organizations need a consistent way to identify, evaluate, control and monitor risks throughout the product lifecycle. It also helps ensure that risk decisions, controls and residual risks remain documented and reviewable as products and processes change.
Defines the Risk Management process, management responsibilities, competence, the risk-management plan and the risk-management file.
General requirements for risk management
Clause 4
Covers intended use, reasonably foreseeable misuse, safety-related characteristics, hazards and estimation of associated risks.
Risk analysis
Clause 5
Requires evaluated risks to be compared with the acceptability criteria defined in the Risk Management plan.
Risk evaluation
Clause 6
Addresses risk-control option analysis, implementation, residual risk, benefit-risk analysis where applicable and risks introduced by controls.
Risk control
Clause 7
Requires the overall residual risk of the medical device to be evaluated against the acceptability criteria.
Evaluation of overall residual risk
Clause 8
Requires review before commercial distribution to confirm the plan was executed, residual risk is acceptable and post-production methods are in place.
Risk management review
Clause 9
Covers collection and review of production and post-production information and its use to determine whether Risk Management action is needed.
Production and post-production activities
Clause 10
Standard explained
Risk-management process in ISO 14971:2019
ISO 14971:2019 remains the current edition and was confirmed in 2025. It defines a lifecycle Risk Management process for medical devices, from planning and hazard analysis through risk control, overall residual-risk evaluation, review and production/post-production information.
The coordinated process of identifying, assessing, treating, monitoring and communicating risks that could affect objectives, safety, quality or compliance.
Risk Management
Process
· Risk
The international quality management system standard specifying regulatory-focused requirements for organizations involved in the design, manufacture and lifecycle of medical devices.
ISO 13485
Standard
· MedTech
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