標準簡介
ISO 14971:2019 是由 國際標準化組織 (ISO) 發布的現行有效標準，常用於醫療器材、醫療健康、科技等產業，並適用於全球等市場。
本頁整理了 ISO 14971:2019 的官方文件、目前狀態以及常見相關認證或評估機構，便於快速理解要求與落地路徑。
Full Lifecycle Coverage
Applies risk management across the entire medical device lifecycle — from initial concept and design through production, post-market surveillance, and decommissioning.
Benefit-Risk Analysis
The 2019 edition places greater emphasis on the overall benefit-risk ratio, requiring manufacturers to weigh clinical benefits against residual risks systematically.
Continuous Process
Risk management is not a one-time activity but an ongoing process that integrates post-production information and state-of-the-art knowledge into risk evaluations.
list_alt Risk Management Process Steps
- Risk management planning and scope definition
- Hazard identification and hazardous situation analysis
- Risk estimation and risk evaluation against acceptability criteria
- Risk control option analysis and implementation
- Evaluation of overall residual risk
- Risk management review and reporting
- Production and post-production information collection
- Integration with ISO 13485 quality management system
Who Needs to Comply?
All medical device manufacturers, including software-as-a-medical-device (SaMD) and in vitro diagnostic (IVD) device makers. Required by the EU MDR, FDA, and most global regulatory frameworks.
Key Requirements
Risk Management Plan
Establish a documented risk management plan defining scope, responsibilities, risk acceptability criteria, verification activities, and review requirements for the entire product lifecycle.
Hazard Identification & Risk Analysis
Systematically identify known and foreseeable hazards in both normal and fault conditions. Estimate risks by analyzing severity of harm and probability of occurrence for each hazardous situation.
Risk Control Measures
Implement risk controls following the priority hierarchy: inherent safety by design, protective measures in the device or manufacturing process, and information for safety (labeling, instructions).
Overall Residual Risk Evaluation
Evaluate the overall residual risk from all identified hazards after all risk control measures are applied, and determine whether the medical benefits outweigh the remaining risks.
Post-Production Monitoring
Collect and review production and post-production information including complaint data, incident reports, and published literature to identify previously unrecognized hazards or risks.
Penalties & Enforcement
No direct penalties for non-compliance with the standard itself. However, failure to demonstrate adequate risk management can result in rejection of regulatory submissions, product recalls, and market access denial under the EU MDR, FDA 21 CFR 820, and other regulations.