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.
Need this as a report you can hand to an assessor? A coverage crosswalk for this pair can be built to order.
According to the TheArtOfService Compliance Knowledge Graph:
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) maps to GDPR with 12% coverage across 3 directly mapped controls. Analysis of 26 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls identifies 23 compliance gaps, primarily concentrated in IVDR - Making Available + Economic Operators (Ch II).
Source: TheArtOfService Knowledge Graph | 26 controls analysed | 704 frameworks | 306K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 3 domains. Sign up to explore all 306K+ mappings across 704 frameworks.
IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)(2 mappings)
IVDR - Introductory Provisions and Scope (Ch I)(1 mappings)
IVDR - Clinical Evidence + Performance Studies (Ch VI)(1 mappings)
A EU In Vitro Diagnostic Medical Devices Regulation (IVDR) to GDPR crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which GDPR controls your existing EU In Vitro Diagnostic Medical Devices Regulation (IVDR) work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
- Every evidenced control, with the reasoning behind it
- Every gap, with what it requires
- Its level of review stated plainly, not a bare number
Why this page shows two different percentages. The 12% in the header counts how many EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many GDPR controls are actually evidenced, after a pass that argued against each mapping and kept only what survived. They answer different questions and they are not meant to agree.
A crosswalk narrows the work. It does not replace an audit, and your assessor may take a different view on individual controls. Mappings between frameworks are judgements, not text printed in either standard, which is why every claim in the report shows its reasoning. Questions go to support@theartofservice.com.
Related Comparisons
Other EU In Vitro Diagnostic Medical Devices Regulation (IVDR) comparisons
Other GDPR comparisons
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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 26 controls across its framework, while GDPR covers 40 controls. Direct mapping analysis identifies 3 overlapping controls (12% coverage). The frameworks diverge most significantly in IVDR - Making Available + Economic Operators (Ch II), where 7 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 26 total EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls, 3 map directly to GDPR controls, representing 12% coverage. The remaining 23 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?
23 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls have no direct equivalent in GDPR. The highest concentration of gaps is in IVDR - Making Available + Economic Operators (Ch II) with 7 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 IVDR - Making Available + Economic Operators (Ch II) (7 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.