IVDR GSPR Compliance Checklist
Document and track compliance with General Safety and Performance Requirements (GSPR) for your IVDR device.
Device Name
*
Device Model or Identifier
*
GSPR Checklist Status
*
Rows
Compliant
Non-Compliant
Not Applicable
GSPR 1: Device achieves intended performance
1
2
3
GSPR 2: Safety and risk minimization
4
5
6
GSPR 3: Chemical, physical, and biological properties
7
8
9
Summary of Evidence for Compliance
*
Upload Supporting Evidence (e.g., test reports, certificates)
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of
Identified Gaps or Non-Compliances
Actions Required to Address Gaps
Reviewer Name
*
Reviewer Role/Position
*
Date of Review
*
-
Month
-
Day
Year
Date
Submit Checklist
Should be Empty: