Cross-Framework Mapping

EU Medical Devices Regulation (MDR 2017/745)vsGDPR

See exactly how EU Medical Devices Regulation (MDR 2017/745) controls map to GDPR. Pre-computed mappings, identified gaps, and coverage analysis.

3
Controls Mapped
23
Gaps Found
8%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

EU Medical Devices Regulation (MDR 2017/745) maps to GDPR 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 | 715 frameworks | 418K+ cross-framework mappings

Control Mappings

Showing 3 of 3 mapped controls across 2 domains. Sign up to explore all 418K+ mappings across 715 frameworks.

MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)(2 mappings)

MDR-Art.109_110_111_112_113_115Confidentiality, data protection, funding, civil liability and penalties (Articles 109-115)2 targets
GDPR-Art.32Security of processing
GDPR-Art.9Processing of special categories of personal data

MDR - Clinical Evaluation + Clinical Investigations (Ch VI)(1 mappings)

MDR-Art.61_62Clinical evaluation and clinical investigations general requirements (Articles 61-62)
GDPR-Art.9Processing of special categories of personal data

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What are the key differences between EU Medical Devices Regulation (MDR 2017/745) and GDPR?

EU Medical Devices Regulation (MDR 2017/745) has 26 controls across its framework, while GDPR covers 38 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 7 EU Medical Devices Regulation (MDR 2017/745) controls have no direct GDPR equivalent.

How many controls map between EU Medical Devices Regulation (MDR 2017/745) and GDPR?

Of 26 total EU Medical Devices Regulation (MDR 2017/745) controls, 2 map directly to GDPR 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 GDPR?

24 EU Medical Devices Regulation (MDR 2017/745) controls have no direct equivalent in GDPR. The highest concentration of gaps is in MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) 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 Medical Devices Regulation (MDR 2017/745) and GDPR?

The domain with the highest gap count is MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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.