21 CFR Part 211 — Current Good Manufacturing PracticevsEU Medical Devices Regulation (MDR 2017/745)
See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to EU Medical Devices Regulation (MDR 2017/745). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
21 CFR Part 211 — Current Good Manufacturing Practice maps to EU Medical Devices Regulation (MDR 2017/745) with 5% coverage across 3 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 54 compliance gaps — primarily concentrated in Subpart J — Records and Reports.
Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Subpart C — Buildings and Facilities(2 mappings)
Subpart F — Production and Process Controls(2 mappings)
Subpart I — Laboratory Controls(2 mappings)
Related Comparisons
Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and EU Medical Devices Regulation (MDR 2017/745)?
21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while EU Medical Devices Regulation (MDR 2017/745) covers 20 controls. Direct mapping analysis identifies 3 overlapping controls (5% coverage). The frameworks diverge most significantly in Subpart J — Records and Reports, where 9 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct EU Medical Devices Regulation (MDR 2017/745) equivalent.
How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and EU Medical Devices Regulation (MDR 2017/745)?
Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 3 map directly to EU Medical Devices Regulation (MDR 2017/745) controls — representing 5% coverage. The remaining 54 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping 21 CFR Part 211 — Current Good Manufacturing Practice to EU Medical Devices Regulation (MDR 2017/745)?
54 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in EU Medical Devices Regulation (MDR 2017/745). The highest concentration of gaps is in Subpart J — Records and Reports with 9 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 21 CFR Part 211 — Current Good Manufacturing Practice and EU Medical Devices Regulation (MDR 2017/745)?
The domain with the highest gap count is Subpart J — Records and Reports (9 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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