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Change Evaluation Report

Use this Change Evaluation Report template to systematically assess and document the impact, verification, and significance of any change requests made to your medical device or quality system. Completing this report is essential for compliance with change management procedures, helping you determine regulatory notification requirements and ensuring all relevant stakeholders are informed whenever a change is approved and implemented. Fill out this template each time a change request is initiated to maintain clear records and support regulatory audits.
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Change Evaluation Report

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1. Scope

This report is used to document the evaluation of change requests according to SOP Change Management. A change evaluation report should be produced for each change request that is approved and initiated.

2. Change Request

2.1 Change Request Number

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2.2. Change Description

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3. Evaluation of Changes

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4. Change Verification

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5. Significance of Change

According to the evaluation of the change, the change is considered to be nonsignificant.

6. Actions to be Performed

Significant changes require that the Notified Body responsible for the conformity assessment of the product are notified of the significant change to the device and the users are to be notified of the significant change as well. If the change is nonsignificant, it can be implemented without notifying the Notified Body but users should be notified of any changes that may affect how users interact or use the device even if nonsignificant.

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