EU Medical Devices Regulation (MDR 2017/745)vsFDA Quality Management System Regulation (QMSR)
See exactly how EU Medical Devices Regulation (MDR 2017/745) 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 Medical Devices Regulation (MDR 2017/745) maps to FDA Quality Management System Regulation (QMSR) with 12% coverage across 3 directly mapped controls. Analysis of 26 EU Medical Devices Regulation (MDR 2017/745) controls identifies 23 compliance gaps — primarily concentrated in MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X).
Source: TheArtOfService Knowledge Graph | 26 controls analysed | 720 frameworks | 432K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 3 domains. Sign up to explore all 432K+ mappings across 720 frameworks.
MDR - Making Available + Economic Operators (Ch II)(1 mappings)
MDR - Clinical Evaluation + Clinical Investigations (Ch VI)(1 mappings)
MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)(1 mappings)
Related Comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
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What are the key differences between EU Medical Devices Regulation (MDR 2017/745) and FDA Quality Management System Regulation (QMSR)?
EU Medical Devices Regulation (MDR 2017/745) 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 MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X), where 7 EU Medical Devices Regulation (MDR 2017/745) controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between EU Medical Devices Regulation (MDR 2017/745) and FDA Quality Management System Regulation (QMSR)?
Of 26 total EU Medical Devices Regulation (MDR 2017/745) 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 Medical Devices Regulation (MDR 2017/745) to FDA Quality Management System Regulation (QMSR)?
23 EU Medical Devices Regulation (MDR 2017/745) controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) with 7 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 Medical Devices Regulation (MDR 2017/745) and FDA Quality Management System Regulation (QMSR)?
The domain with the highest gap count is MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) (7 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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