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Cross-Framework Mapping

EU Medical Devices Regulation (MDR 2017/745)vsNIST SP 800-171A Rev 3 — Assessing CUI Security Requirements

See exactly how EU Medical Devices Regulation (MDR 2017/745) controls map to NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements. Pre-computed mappings, identified gaps, and coverage analysis.

14
Controls Mapped
6
Gaps Found
40%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

EU Medical Devices Regulation (MDR 2017/745) maps to NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements with 40% coverage across 8 directly mapped controls. Analysis of 20 EU Medical Devices Regulation (MDR 2017/745) controls identifies 12 compliance gaps — primarily concentrated in Annex I — General Safety and Performance Requirements.

Source: TheArtOfService Knowledge Graph | 20 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 14 of 14 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Annex I — General Safety and Performance Requirements(5 mappings)

MDR-AI-01Risk Management2 targets
→3.16System and Services Acquisition
→3.17Supply Chain Risk Management
MDR-AI-03Infection and Microbial Contamination3 targets
→3.1Food Safety and Quality Manual
→3.2Document Control
→3.4Internal Audits

Chapter III — Economic Operators(5 mappings)

MDR-III-01Manufacturer General Obligations
→3.1Food Safety and Quality Manual
MDR-III-02Person Responsible for Regulatory Compliance
→3.1Food Safety and Quality Manual
MDR-III-04Traceability Requirements3 targets
→3.1Food Safety and Quality Manual
→3.2Document Control
→3.4Internal Audits

Chapter VII — Post-Market Surveillance(4 mappings)

MDR-VII-01Post-Market Surveillance System
→3.12Security Assessment and Monitoring
MDR-VII-02Periodic Safety Update Report (PSUR)2 targets
→3.1Food Safety and Quality Manual
→3.12Security Assessment and Monitoring
MDR-VII-05Post-Market Clinical Follow-up (PMCF)
→3.12Security Assessment and Monitoring

Related Comparisons

Other EU Medical Devices Regulation (MDR 2017/745) comparisons

EU Medical Devices Regulation (MDR 2017/745) vs ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence8 mappingsEU Medical Devices Regulation (MDR 2017/745) vs ICH E6(R3) — Good Clinical Practice8 mappingsEU Medical Devices Regulation (MDR 2017/745) vs PIC/S Guide to Good Manufacturing Practice for Medicinal Products8 mappingsEU Medical Devices Regulation (MDR 2017/745) vs Notifiable Data Breaches Scheme (Australia)8 mappingsEU Medical Devices Regulation (MDR 2017/745) vs EU Digital Markets Act8 mappingsEU Medical Devices Regulation (MDR 2017/745) vs FTC Health Breach Notification Rule8 mappingsEU Medical Devices Regulation (MDR 2017/745) vs UK Product Security and Telecommunications Infrastructure Act (PSTI)8 mappingsEU Medical Devices Regulation (MDR 2017/745) vs EAR — Export Administration Regulations8 mappings

Other NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements comparisons

UK Telecommunications (Security) Act 2021 vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsSouth Korea Cloud Security Assurance Program (CSAP) vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsPAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsCanada ITSG-33 — IT Security Risk Management vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsNew Zealand Information Security Manual (NZISM) vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsMARS-E — Minimum Acceptable Risk Standards for Exchanges vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsNRC 10 CFR 73.54 — Nuclear Facility Cybersecurity vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements21 mappingsTISAX — Trusted Information Security Assessment Exchange vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements20 mappings

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What are the key differences between EU Medical Devices Regulation (MDR 2017/745) and NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements?

EU Medical Devices Regulation (MDR 2017/745) has 20 controls across its framework, while NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements covers 35 controls. Direct mapping analysis identifies 8 overlapping controls (40% coverage). The frameworks diverge most significantly in Annex I — General Safety and Performance Requirements, where 4 EU Medical Devices Regulation (MDR 2017/745) controls have no direct NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements equivalent.

How many controls map between EU Medical Devices Regulation (MDR 2017/745) and NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements?

Of 20 total EU Medical Devices Regulation (MDR 2017/745) controls, 8 map directly to NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements controls — representing 40% coverage. The remaining 12 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 NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements?

12 EU Medical Devices Regulation (MDR 2017/745) controls have no direct equivalent in NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements. The highest concentration of gaps is in Annex I — General Safety and Performance Requirements 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 Medical Devices Regulation (MDR 2017/745) and NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements?

The domain with the highest gap count is Annex I — General Safety and Performance Requirements (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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