EN ISO 14971
EN ISO 14971:2019 is the reference standard for medical device risk management and is an integral part of MDR (EU) 2017/745 requirements.
The risk management process per EN ISO 14971 comprises:
1. Risk analysis: identification of hazards and harms, estimation of probability and severity
2. Risk evaluation: comparison against predefined acceptability criteria
3. Risk control: application of measures in sequence (inherently safe design, protective measures, safety information)
4. Residual risk evaluation
5. Benefit-risk assessment: overall risk vs. clinical benefit
Risk management outputs feed directly into clinical evaluation (EN ISO 14155, MEDDEV 2.7/1) and technical documentation.
EN ISO 14971 applies to all device classes (I to III) and is the binding reference for both manufacturers and Notified Bodies.
Distinction: risk management per EN ISO 14971 addresses product risks. Occupational risks (workplace safety) are governed by separate frameworks.
Frequently asked questions
What steps does risk management per EN ISO 14971 involve?
Risk analysis (identify hazards), risk evaluation (assess acceptability), risk control (apply measures: inherently safe design, protective measures, safety information), residual risk evaluation, and benefit-risk assessment.
Is EN ISO 14971 relevant for Class I products like single-use gloves?
Yes. EN ISO 14971 applies to all classes. For Class I medical devices such as single-use gloves, the manufacturer must also create a risk management file and document residual risk.
What is the difference between risk management per EN ISO 14971 and occupational safety?
EN ISO 14971 addresses risks posed by the medical device to patients, users, and third parties. Occupational health risks for manufacturing employees are governed by separate national and European frameworks.