EU Medical Devices Regulation (MDR 2017/745)vsFTC Health Breach Notification Rule
See exactly how EU Medical Devices Regulation (MDR 2017/745) controls map to FTC Health Breach Notification Rule. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
EU Medical Devices Regulation (MDR 2017/745) maps to FTC Health Breach Notification Rule with 40% coverage across 8 directly mapped controls. Analysis of 20 EU Medical Devices Regulation (MDR 2017/745) controls identifies 12 compliance gaps — primarily concentrated in Annex I — General Safety and Performance Requirements.
Source: TheArtOfService Knowledge Graph | 20 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 11 of 11 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Annex I — General Safety and Performance Requirements(1 mappings)
Chapter II — Device Classification and Conformity(3 mappings)
Chapter III — Economic Operators(4 mappings)
Chapter VII — Post-Market Surveillance(3 mappings)
Related Comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
Other FTC Health Breach Notification Rule comparisons
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What are the key differences between EU Medical Devices Regulation (MDR 2017/745) and FTC Health Breach Notification Rule?
EU Medical Devices Regulation (MDR 2017/745) has 20 controls across its framework, while FTC Health Breach Notification Rule covers 50 controls. Direct mapping analysis identifies 8 overlapping controls (40% coverage). The frameworks diverge most significantly in Annex I — General Safety and Performance Requirements, where 5 EU Medical Devices Regulation (MDR 2017/745) controls have no direct FTC Health Breach Notification Rule equivalent.
How many controls map between EU Medical Devices Regulation (MDR 2017/745) and FTC Health Breach Notification Rule?
Of 20 total EU Medical Devices Regulation (MDR 2017/745) controls, 8 map directly to FTC Health Breach Notification Rule controls — representing 40% coverage. The remaining 12 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 FTC Health Breach Notification Rule?
12 EU Medical Devices Regulation (MDR 2017/745) controls have no direct equivalent in FTC Health Breach Notification Rule. The highest concentration of gaps is in Annex I — General Safety and Performance Requirements with 5 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 FTC Health Breach Notification Rule?
The domain with the highest gap count is Annex I — General Safety and Performance Requirements (5 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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