EU Medical Devices Regulation (MDR 2017/745)vsPIC/S Guide to Good Manufacturing Practice for Medicinal Products
See exactly how EU Medical Devices Regulation (MDR 2017/745) controls map to PIC/S Guide to Good Manufacturing Practice for Medicinal Products. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
EU Medical Devices Regulation (MDR 2017/745) maps to PIC/S Guide to Good Manufacturing Practice for Medicinal Products 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 Chapter VII — Post-Market Surveillance.
Source: TheArtOfService Knowledge Graph | 20 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 15 of 15 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Annex I — General Safety and Performance Requirements(5 mappings)
Chapter II — Device Classification and Conformity(1 mappings)
Chapter III — Economic Operators(7 mappings)
Chapter VII — Post-Market Surveillance(2 mappings)
Related Comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
Other PIC/S Guide to Good Manufacturing Practice for Medicinal Products comparisons
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What are the key differences between EU Medical Devices Regulation (MDR 2017/745) and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
EU Medical Devices Regulation (MDR 2017/745) has 20 controls across its framework, while PIC/S Guide to Good Manufacturing Practice for Medicinal Products covers 17 controls. Direct mapping analysis identifies 8 overlapping controls (40% coverage). The frameworks diverge most significantly in Chapter VII — Post-Market Surveillance, where 4 EU Medical Devices Regulation (MDR 2017/745) controls have no direct PIC/S Guide to Good Manufacturing Practice for Medicinal Products equivalent.
How many controls map between EU Medical Devices Regulation (MDR 2017/745) and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
Of 20 total EU Medical Devices Regulation (MDR 2017/745) controls, 8 map directly to PIC/S Guide to Good Manufacturing Practice for Medicinal Products 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 PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
12 EU Medical Devices Regulation (MDR 2017/745) controls have no direct equivalent in PIC/S Guide to Good Manufacturing Practice for Medicinal Products. The highest concentration of gaps is in Chapter VII — Post-Market Surveillance 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 PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
The domain with the highest gap count is Chapter VII — Post-Market Surveillance (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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