ICH E6(R3) — Good Clinical PracticevsEU Medical Devices Regulation (MDR 2017/745)
See exactly how ICH E6(R3) — Good Clinical Practice controls map to EU Medical Devices Regulation (MDR 2017/745). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ICH E6(R3) — Good Clinical Practice maps to EU Medical Devices Regulation (MDR 2017/745) with 29% coverage across 5 directly mapped controls. Analysis of 17 ICH E6(R3) — Good Clinical Practice controls identifies 12 compliance gaps — primarily concentrated in Overarching Principles.
Source: TheArtOfService Knowledge Graph | 17 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 15 of 15 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Annex 1 - Data Governance(8 mappings)
Annex 1 - Sponsor Responsibilities(3 mappings)
Annex 2 - Non-Traditional Interventional Clinical Trials(3 mappings)
Overarching Principles(1 mappings)
Related Comparisons
Other ICH E6(R3) — Good Clinical Practice comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
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What are the key differences between ICH E6(R3) — Good Clinical Practice and EU Medical Devices Regulation (MDR 2017/745)?
ICH E6(R3) — Good Clinical Practice has 17 controls across its framework, while EU Medical Devices Regulation (MDR 2017/745) covers 20 controls. Direct mapping analysis identifies 5 overlapping controls (29% coverage). The frameworks diverge most significantly in Overarching Principles, where 4 ICH E6(R3) — Good Clinical Practice controls have no direct EU Medical Devices Regulation (MDR 2017/745) equivalent.
How many controls map between ICH E6(R3) — Good Clinical Practice and EU Medical Devices Regulation (MDR 2017/745)?
Of 17 total ICH E6(R3) — Good Clinical Practice controls, 5 map directly to EU Medical Devices Regulation (MDR 2017/745) controls — representing 29% 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 ICH E6(R3) — Good Clinical Practice to EU Medical Devices Regulation (MDR 2017/745)?
12 ICH E6(R3) — Good Clinical Practice controls have no direct equivalent in EU Medical Devices Regulation (MDR 2017/745). The highest concentration of gaps is in Overarching Principles with 4 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 ICH E6(R3) — Good Clinical Practice and EU Medical Devices Regulation (MDR 2017/745)?
The domain with the highest gap count is Overarching Principles (4 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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