EU Medical Devices Regulation (MDR 2017/745)vsEU Clinical Trials Regulation (CTR 536/2014)
See exactly how EU Medical Devices Regulation (MDR 2017/745) controls map to EU Clinical Trials Regulation (CTR 536/2014). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
EU Medical Devices Regulation (MDR 2017/745) maps to EU Clinical Trials Regulation (CTR 536/2014) with 8% coverage across 2 directly mapped controls. Analysis of 26 EU Medical Devices Regulation (MDR 2017/745) controls identifies 24 compliance gaps — primarily concentrated in MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X).
Source: TheArtOfService Knowledge Graph | 26 controls analysed | 701 frameworks | 337K+ cross-framework mappings
Control Mappings
Showing 2 of 2 mapped controls across 1 domains. Sign up to explore all 337K+ mappings across 701 frameworks.
MDR - Clinical Evaluation + Clinical Investigations (Ch VI)(2 mappings)
Related Comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
Other EU Clinical Trials Regulation (CTR 536/2014) comparisons
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What are the key differences between EU Medical Devices Regulation (MDR 2017/745) and EU Clinical Trials Regulation (CTR 536/2014)?
EU Medical Devices Regulation (MDR 2017/745) has 26 controls across its framework, while EU Clinical Trials Regulation (CTR 536/2014) covers 30 controls. Direct mapping analysis identifies 2 overlapping controls (8% coverage). The frameworks diverge most significantly in MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X), where 8 EU Medical Devices Regulation (MDR 2017/745) controls have no direct EU Clinical Trials Regulation (CTR 536/2014) equivalent.
How many controls map between EU Medical Devices Regulation (MDR 2017/745) and EU Clinical Trials Regulation (CTR 536/2014)?
Of 26 total EU Medical Devices Regulation (MDR 2017/745) controls, 2 map directly to EU Clinical Trials Regulation (CTR 536/2014) controls — representing 8% coverage. The remaining 24 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 EU Clinical Trials Regulation (CTR 536/2014)?
24 EU Medical Devices Regulation (MDR 2017/745) controls have no direct equivalent in EU Clinical Trials Regulation (CTR 536/2014). The highest concentration of gaps is in MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) with 8 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 EU Clinical Trials Regulation (CTR 536/2014)?
The domain with the highest gap count is MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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