EU Clinical Trials Regulation (CTR 536/2014)vsEU In Vitro Diagnostic Medical Devices Regulation (IVDR)
See exactly how EU Clinical Trials Regulation (CTR 536/2014) controls map to EU In Vitro Diagnostic Medical Devices Regulation (IVDR). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
EU Clinical Trials Regulation (CTR 536/2014) maps to EU In Vitro Diagnostic Medical Devices Regulation (IVDR) with 13% coverage across 4 directly mapped controls. Analysis of 30 EU Clinical Trials Regulation (CTR 536/2014) controls identifies 26 compliance gaps — primarily concentrated in CTR - Conduct, Manufacturing and Labelling (Ch VIII-X).
Source: TheArtOfService Knowledge Graph | 30 controls analysed | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
Showing 5 of 5 mapped controls across 2 domains. Sign up to explore all 323K+ mappings across 700 frameworks.
CTR - Subject Protection and Informed Consent (Ch V)(4 mappings)
CTR - Start, End and Safety Reporting (Ch VI-VII)(1 mappings)
Related Comparisons
Other EU Clinical Trials Regulation (CTR 536/2014) comparisons
Other EU In Vitro Diagnostic Medical Devices Regulation (IVDR) comparisons
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What are the key differences between EU Clinical Trials Regulation (CTR 536/2014) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?
EU Clinical Trials Regulation (CTR 536/2014) has 30 controls across its framework, while EU In Vitro Diagnostic Medical Devices Regulation (IVDR) covers 26 controls. Direct mapping analysis identifies 4 overlapping controls (13% coverage). The frameworks diverge most significantly in CTR - Conduct, Manufacturing and Labelling (Ch VIII-X), where 6 EU Clinical Trials Regulation (CTR 536/2014) controls have no direct EU In Vitro Diagnostic Medical Devices Regulation (IVDR) equivalent.
How many controls map between EU Clinical Trials Regulation (CTR 536/2014) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?
Of 30 total EU Clinical Trials Regulation (CTR 536/2014) controls, 4 map directly to EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls — representing 13% coverage. The remaining 26 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping EU Clinical Trials Regulation (CTR 536/2014) to EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?
26 EU Clinical Trials Regulation (CTR 536/2014) controls have no direct equivalent in EU In Vitro Diagnostic Medical Devices Regulation (IVDR). The highest concentration of gaps is in CTR - Conduct, Manufacturing and Labelling (Ch VIII-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 Clinical Trials Regulation (CTR 536/2014) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?
The domain with the highest gap count is CTR - Conduct, Manufacturing and Labelling (Ch VIII-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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