EU In Vitro Diagnostic Medical Devices Regulation (IVDR)vsFDA Quality Management System Regulation (QMSR)
See exactly how EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) maps to FDA Quality Management System Regulation (QMSR) with 12% coverage across 3 directly mapped controls. Analysis of 26 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls identifies 23 compliance gaps — primarily concentrated in IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X).
Source: TheArtOfService Knowledge Graph | 26 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
IVDR - Making Available + Economic Operators (Ch II)(1 mappings)
IVDR - Clinical Evidence + Performance Studies (Ch VI)(1 mappings)
IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)(1 mappings)
Related Comparisons
Other EU In Vitro Diagnostic Medical Devices Regulation (IVDR) comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
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What are the key differences between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and FDA Quality Management System Regulation (QMSR)?
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) has 26 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 3 overlapping controls (12% coverage). The frameworks diverge most significantly in IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X), where 6 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and FDA Quality Management System Regulation (QMSR)?
Of 26 total EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls, 3 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 12% coverage. The remaining 23 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping EU In Vitro Diagnostic Medical Devices Regulation (IVDR) to FDA Quality Management System Regulation (QMSR)?
23 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) with 6 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.
Which control domains have the most gaps between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and FDA Quality Management System Regulation (QMSR)?
The domain with the highest gap count is IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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