EU Medical Devices Regulation (MDR 2017/745)vsISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
See exactly how EU Medical Devices Regulation (MDR 2017/745) controls map to ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
EU Medical Devices Regulation (MDR 2017/745) maps to ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence 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 20 of 25 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Annex I — General Safety and Performance Requirements(7 mappings)
Chapter II — Device Classification and Conformity(3 mappings)
Chapter III — Economic Operators(10 mappings)
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Related Comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
Other ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence comparisons
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What are the key differences between EU Medical Devices Regulation (MDR 2017/745) and ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
EU Medical Devices Regulation (MDR 2017/745) has 20 controls across its framework, while ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence covers 64 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 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence equivalent.
How many controls map between EU Medical Devices Regulation (MDR 2017/745) and ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
Of 20 total EU Medical Devices Regulation (MDR 2017/745) controls, 8 map directly to ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence 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 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
12 EU Medical Devices Regulation (MDR 2017/745) controls have no direct equivalent in ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence. 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 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence?
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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