EU Clinical Trials Regulation (CTR 536/2014)vsEU Medical Devices Regulation (MDR 2017/745)
See exactly how EU Clinical Trials Regulation (CTR 536/2014) controls map to EU Medical Devices Regulation (MDR 2017/745). 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 Clinical Trials Regulation (CTR 536/2014) maps to EU Medical Devices Regulation (MDR 2017/745) with 7% coverage across 2 directly mapped controls. Analysis of 30 EU Clinical Trials Regulation (CTR 536/2014) controls identifies 28 compliance gaps, primarily concentrated in CTR - Conduct, Manufacturing and Labelling (Ch VIII-X).
Source: TheArtOfService Knowledge Graph | 30 controls analysed | 704 frameworks | 306K+ cross-framework mappings
Control Mappings
Showing 2 of 2 mapped controls across 2 domains. Sign up to explore all 306K+ mappings across 704 frameworks.
CTR - Subject Protection and Informed Consent (Ch V)(1 mappings)
CTR - Start, End and Safety Reporting (Ch VI-VII)(1 mappings)
A EU Clinical Trials Regulation (CTR 536/2014) to EU Medical Devices Regulation (MDR 2017/745) crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which EU Medical Devices Regulation (MDR 2017/745) controls your existing EU Clinical Trials Regulation (CTR 536/2014) 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 7% in the header counts how many EU Clinical Trials Regulation (CTR 536/2014) controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many EU Medical Devices Regulation (MDR 2017/745) 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 Clinical Trials Regulation (CTR 536/2014) comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
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What are the key differences between EU Clinical Trials Regulation (CTR 536/2014) and EU Medical Devices Regulation (MDR 2017/745)?
EU Clinical Trials Regulation (CTR 536/2014) has 30 controls across its framework, while EU Medical Devices Regulation (MDR 2017/745) covers 26 controls. Direct mapping analysis identifies 2 overlapping controls (7% 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 Medical Devices Regulation (MDR 2017/745) equivalent.
How many controls map between EU Clinical Trials Regulation (CTR 536/2014) and EU Medical Devices Regulation (MDR 2017/745)?
Of 30 total EU Clinical Trials Regulation (CTR 536/2014) controls, 2 map directly to EU Medical Devices Regulation (MDR 2017/745) controls, representing 7% coverage. The remaining 28 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 Medical Devices Regulation (MDR 2017/745)?
28 EU Clinical Trials Regulation (CTR 536/2014) controls have no direct equivalent in EU Medical Devices Regulation (MDR 2017/745). 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 Medical Devices Regulation (MDR 2017/745)?
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
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.