API 1164vsEU Medical Devices Regulation (MDR 2017/745)
See exactly how API 1164 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:
API 1164 maps to EU Medical Devices Regulation (MDR 2017/745) with 8% coverage across 2 directly mapped controls. Analysis of 24 API 1164 controls identifies 22 compliance gaps — primarily concentrated in API 1164: Incident Response & Recovery.
Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
API 1164: Systems Security(3 mappings)
API 1164: Supply Chain & Configuration(1 mappings)
Related Comparisons
Other API 1164 comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 693 frameworks — at a fraction of consulting costs.
Free
- ✓ 693 framework browser
- ✓ Cross-framework mappings (819K+)
- ✓ 824 compliance assessments
- ✓ 3 AI queries & searches per day
Professional
- ✓ Unlimited AI Compliance Advisory
- ✓ Unlimited full-text search
- ✓ Framework self-assessment
- ✓ PDF, Excel & CSV exports
What are the key differences between API 1164 and EU Medical Devices Regulation (MDR 2017/745)?
API 1164 has 24 controls across its framework, while EU Medical Devices Regulation (MDR 2017/745) covers 20 controls. Direct mapping analysis identifies 2 overlapping controls (8% coverage). The frameworks diverge most significantly in API 1164: Incident Response & Recovery, where 5 API 1164 controls have no direct EU Medical Devices Regulation (MDR 2017/745) equivalent.
How many controls map between API 1164 and EU Medical Devices Regulation (MDR 2017/745)?
Of 24 total API 1164 controls, 2 map directly to EU Medical Devices Regulation (MDR 2017/745) controls — representing 8% coverage. The remaining 22 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping API 1164 to EU Medical Devices Regulation (MDR 2017/745)?
22 API 1164 controls have no direct equivalent in EU Medical Devices Regulation (MDR 2017/745). The highest concentration of gaps is in API 1164: Incident Response & Recovery with 5 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 API 1164 and EU Medical Devices Regulation (MDR 2017/745)?
The domain with the highest gap count is API 1164: Incident Response & Recovery (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.