EU In Vitro Diagnostic Medical Devices Regulation (IVDR)vsGDPR
See exactly how EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls map to GDPR. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) maps to GDPR with 39% coverage across 9 directly mapped controls. Analysis of 23 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls identifies 14 compliance gaps — primarily concentrated in Post-Market Surveillance and Vigilance.
Source: TheArtOfService Knowledge Graph | 23 controls analysed | 693 frameworks | 820K+ cross-framework mappings
Control Mappings
Showing 20 of 32 mapped controls across 5 domains. Sign up to explore all 820K+ mappings across 693 frameworks.
Introductory Provisions(1 mappings)
Identification, Traceability and Registration(14 mappings)
Notified Bodies and Conformity Assessment(5 mappings)
+12 more mappings
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What are the key differences between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and GDPR?
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) has 23 controls across its framework, while GDPR covers 44 controls. Direct mapping analysis identifies 9 overlapping controls (39% coverage). The frameworks diverge most significantly in Post-Market Surveillance and Vigilance, where 4 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls have no direct GDPR equivalent.
How many controls map between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and GDPR?
Of 23 total EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls, 9 map directly to GDPR controls — representing 39% coverage. The remaining 14 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping EU In Vitro Diagnostic Medical Devices Regulation (IVDR) to GDPR?
14 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls have no direct equivalent in GDPR. The highest concentration of gaps is in Post-Market Surveillance and Vigilance 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 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and GDPR?
The domain with the highest gap count is Post-Market Surveillance and Vigilance (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.