ISO 15189:2022 — Medical Laboratories Requirements for Quality and CompetencevsEU Medical Devices Regulation (MDR 2017/745)
See exactly how ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence 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:
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence maps to EU Medical Devices Regulation (MDR 2017/745) with 14% coverage across 9 directly mapped controls. Analysis of 64 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls identifies 55 compliance gaps — primarily concentrated in Clause 7: Process Requirements.
Source: TheArtOfService Knowledge Graph | 64 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.
Clause 5: Structural and Governance Requirements(4 mappings)
Clause 6: Resource Requirements(6 mappings)
Clause 7: Process Requirements(3 mappings)
Clause 8: Management System Requirements(7 mappings)
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Related Comparisons
Other ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
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What are the key differences between ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and EU Medical Devices Regulation (MDR 2017/745)?
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence has 64 controls across its framework, while EU Medical Devices Regulation (MDR 2017/745) covers 20 controls. Direct mapping analysis identifies 9 overlapping controls (14% coverage). The frameworks diverge most significantly in Clause 7: Process Requirements, where 18 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls have no direct EU Medical Devices Regulation (MDR 2017/745) equivalent.
How many controls map between ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and EU Medical Devices Regulation (MDR 2017/745)?
Of 64 total ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls, 9 map directly to EU Medical Devices Regulation (MDR 2017/745) controls — representing 14% coverage. The remaining 55 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence to EU Medical Devices Regulation (MDR 2017/745)?
55 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence controls have no direct equivalent in EU Medical Devices Regulation (MDR 2017/745). The highest concentration of gaps is in Clause 7: Process Requirements with 18 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 ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence and EU Medical Devices Regulation (MDR 2017/745)?
The domain with the highest gap count is Clause 7: Process Requirements (18 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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