Change Evaluation Report
Summary
The Change Evaluation Report documents the evaluation of approved change requests after implementation. It assesses the impact of changes on device safety and performance, determines whether changes are significant or nonsignificant, and guides decisions about notified body notifications and user communications.
Why is Change Evaluation Report important?
Change evaluation reports are essential for demonstrating regulatory compliance and maintaining market authorization for your medical device. They provide evidence that you have systematically evaluated the impact of changes on device safety, effectiveness, and regulatory status. This documentation helps determine whether changes require notified body notification, supports post-market surveillance activities, and ensures that users receive appropriate information about device modifications.
Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation):
- Design changes must be verified and validated as appropriate (820.30(f))
- Changes require documentation and approval (820.30(i))
- Risk analysis must be updated for changes affecting safety (820.30(g))
- Significant changes may require new 510(k) submission or FDA notification
- Changes must be evaluated against predicate device comparison
Special attention required for:
- Changes affecting substantial equivalence determination
- Modifications that could impact device classification
- Software changes that alter core functionality or safety features
- Changes requiring updated labeling or instructions for use
Under 21 CFR Part 820 (Quality System Regulation):
- Design changes must be verified and validated as appropriate (820.30(f))
- Changes require documentation and approval (820.30(i))
- Risk analysis must be updated for changes affecting safety (820.30(g))
- Significant changes may require new 510(k) submission or FDA notification
- Changes must be evaluated against predicate device comparison
Special attention required for:
- Changes affecting substantial equivalence determination
- Modifications that could impact device classification
- Software changes that alter core functionality or safety features
- Changes requiring updated labeling or instructions for use
Under EU MDR 2017/745:
- Significant changes require notified body notification under Article 120
- Changes must be evaluated against general safety and performance requirements
- Technical documentation must reflect current device state (Annex II)
- Manufacturers must assess change significance using specific criteria
- CE marking validity depends on change significance assessment
Special attention required for:
- Six specific criteria for determining change significance (Article 120)
- EUDAMED registration updates for device modifications
- Clinical evaluation updates for changes affecting safety or performance
- Post-market surveillance plan updates for significant changes
Guide
Linking to Change Requests
Reference the original change request by providing its document number and ensuring traceability between the request and evaluation. This connection demonstrates that changes were properly authorized and that the evaluation addresses the originally proposed modifications.
Describe implemented changes in detail, including any deviations from the original change request. Document new or changed code, updated documentation, modified processes, and any new requirements or risks that were identified during implementation.
Impact Evaluation Framework
Assess changes against regulatory criteria systematically. For EU MDR compliance, evaluate whether changes impact intended use, patient population, contraindications, general safety and performance requirements, risk profile, clinical performance, built-in control mechanisms, or core algorithms. For FDA compliance, consider impacts on substantial equivalence, device classification, and predicate device comparison.
Document your evaluation rationale for each criterion. Provide specific explanations for why you determined that a particular aspect was or was not impacted. This documentation demonstrates thorough analysis and supports your significance determination.
Verification and Validation Evidence
Document verification activities that demonstrate changes were implemented correctly. Include testing results, code reviews, documentation updates, and any other evidence that confirms the changes work as intended and don’t introduce new problems.
Provide validation evidence when changes affect device performance or user interaction. This may include updated usability testing, clinical data analysis, or performance verification that demonstrates the changed device continues to meet user needs and safety requirements.
Significance Determination
Apply significance criteria consistently based on your evaluation results. If any evaluation criterion indicates significant impact, the overall change should be classified as significant. This conservative approach ensures appropriate regulatory oversight and user notification.
Consider cumulative effects of multiple changes when evaluating significance. Even individually minor changes may become significant when considered together, particularly if they affect related device functions or user interactions.
Regulatory and User Communication
Plan notified body communications for significant changes. Prepare the necessary documentation and notifications required by your notified body, including updated technical documentation and change impact assessments.
Determine user notification requirements based on change significance and impact on device use. Even nonsignificant changes may require user notification if they affect device operation, user interface, or safety information.
Example
Scenario
Following your approved change request to add heart rate variability (HRV) analysis to your cardiac monitoring app, you have implemented the new functionality. The implementation included new algorithms, user interface changes, additional data storage, and updated documentation. Now you need to evaluate whether this change is significant and determine next steps for regulatory compliance and user communication.
Change Evaluation Report Document
Change Request Number: CR-2024-003
Change Description: Successfully implemented heart rate variability (HRV) analysis and display functionality in CardioTracker Mobile App v3.3.0. The implementation included:
- New Code: Integrated time-domain HRV analysis algorithms (RMSSD, pNN50, SDNN) with real-time calculation capabilities
- Documentation Updates: Updated system requirements list, software architecture document, user manual, and risk management file
- Testing Performed: Completed verification testing of HRV algorithms, usability testing of new interface elements, and regression testing of existing functionality
- Process Changes: Updated software development procedures to include HRV algorithm validation requirements
Evaluation of Changes:
| Evaluation Criteria | Impact | Details |
|---|---|---|
| Does the change impact the intended use, patient population, intended users, use environment, contraindications, or interaction with the body? | Impacted | Intended use expanded to include HRV monitoring for cardiac patients. Patient population remains the same but now includes additional monitoring capability. |
| Does the change impact the device’s conformity with the general safety and performance requirements? | Not Impacted | Device continues to meet all GSPR requirements. HRV functionality enhances monitoring capabilities without compromising existing safety features. |
| Does the change introduce new risks that require control measures or is the existing risk profile for the device negatively affected by the new risks? | Impacted | New risk identified: R-087 - Incorrect HRV calculation could lead to misinterpretation of cardiac status. Risk controls implemented through algorithm validation and user training materials. |
| Does the change have an impact on clinical performance or safety which necessitates additional clinical or usability testing? | Impacted | Usability testing performed to validate new HRV interface elements. Clinical literature review conducted to support HRV parameter selection and normal ranges. |
| Does the change alter built-in control mechanisms or alarms, core operating principles, operating systems or sources of energy or introduce a new channel of interoperability? | Not Impacted | No changes to existing alarms or control mechanisms. HRV analysis operates as additional monitoring feature without affecting core heart rate monitoring functions. |
| Does the change introduce a new or change to the algorithm used for the core medical functionality? | Impacted | New HRV analysis algorithms added for medical functionality. Algorithms validated against established clinical standards and tested with diverse patient data sets. |
Change Verification: Comprehensive verification performed including:
- Algorithm accuracy testing against reference implementations with >99% correlation
- Usability testing with 15 healthcare professionals confirming intuitive interface design
- Regression testing of all existing functionality with 100% pass rate
- Performance testing confirming HRV calculations complete within 2 seconds
- Updated risk management file with new risk controls validated through testing
Significance of Change: According to the evaluation of the change, the change is considered to be Significant.
Actions to be Performed: As this is a significant change:
- Notified Body Notification: Submit change notification to TÜV SÜD including updated technical documentation, change evaluation report, and verification evidence
- User Notification: Prepare user communication describing new HRV functionality, including updated user manual and training materials for healthcare providers
- EUDAMED Update: Update device registration in EUDAMED to reflect new HRV monitoring capabilities
- Clinical Evaluation Update: Update clinical evaluation report to include HRV functionality and supporting clinical literature
- Post-Market Surveillance: Monitor user feedback and clinical outcomes related to HRV functionality through enhanced post-market surveillance activities