ISO 14971:2019 vs 2007: Key Changes Every Medical Device Manufacturer Should Know

ISO 14971:2019 brought significant changes to medical device risk management. Understanding these changes is crucial for maintaining compliance.

Major Changes Overview

1. Risk Acceptability Criteria

2007 Version: Required establishing risk acceptability criteria upfront.

2019 Version: Focuses on benefit-risk analysis and risk-benefit ratio.

2. ALARP Principle

2007 Version: Explicit ALARP (As Low As Reasonably Practicable) requirement.

2019 Version: Removed explicit ALARP requirement, focusing instead on benefit-risk analysis.

3. Residual Risk Evaluation

2007 Version: Binary accept/reject decision on residual risks.

2019 Version: Must evaluate overall residual risk considering benefits.

4. Production and Post-Production Information

2007 Version: Limited requirements for post-market data.

2019 Version: Enhanced requirements for production and post-production information review.

Transition Strategy

1. Review your current risk management process
2. Update risk management plan
3. Revise risk acceptability criteria
4. Enhance benefit-risk analysis procedures
5. Update training materials

Impact on Software Devices

For software medical devices, the changes affect:

• Cybersecurity risk management
• Software updates risk assessment
• Post-market surveillance integration

Transitioning to ISO 14971:2019? Captain Compliant can help identify gaps and streamline your transition.