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Cross-Framework Mapping

NIS2 DirectivevsEU In Vitro Diagnostic Medical Devices Regulation (IVDR)

See exactly how NIS2 Directive controls map to EU In Vitro Diagnostic Medical Devices Regulation (IVDR). Pre-computed mappings, identified gaps, and coverage analysis.

40
Controls Mapped
40
Gaps Found
26%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

NIS2 Directive maps to EU In Vitro Diagnostic Medical Devices Regulation (IVDR) with 26% coverage across 21 directly mapped controls. Analysis of 80 NIS2 Directive controls identifies 59 compliance gaps — primarily concentrated in Other.

Source: TheArtOfService Knowledge Graph | 80 controls analysed | 769 frameworks | 815K+ cross-framework mappings

Control Mappings

Showing 20 of 40 mapped controls across 7 domains. Sign up to explore all 815K+ mappings across 769 frameworks.

Incident Reporting(6 mappings)

Art.10Cases When Authorization Is Not Required2 targets
→Art. 2Consent Definition
→Art. 4Participating Institutions
Art.16Computer-Related Forgery and Fraud4 targets
→Art. 26Obligations of Deployers of High-Risk AI Systems
→Art. 29Application of a Conformity Assessment Body for Notification
→Art. 47Existing Legal Procedures
→Art. 58Scientific Research Data

Risk Management(2 mappings)

Art.12Prohibition of Illegal Interception
→Art. 56Data Breach Notification
Art.21Functions of the SIC Specific to Personal Data
→Art. 28Notifying Authorities

Governance(10 mappings)

Art.13Prohibition of Data Interference
→Art. 48Criminal Penalties
Art.19Superintendencia de Industria y Comercio Functions
→Art. 52Procedure
Art.20Service Provider Duties
→Art. 48Criminal Penalties
Art.26Production Orders
→Art. 52Procedure
Art.7Children's Data4 targets
→Art. 26Obligations of Deployers of High-Risk AI Systems
→Art. 29Application of a Conformity Assessment Body for Notification
→Art. 47Existing Legal Procedures
→Art. 58Scientific Research Data
Art.8Rights of Data Subjects2 targets
→Art. 2Consent Definition
→Art. 4Participating Institutions

Other(2 mappings)

Art.2Scope2 targets
→Art. 2Consent Definition
→Art. 4Participating Institutions

+20 more mappings

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Related Comparisons

Other NIS2 Directive comparisons

NIS2 Directive vs PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments28 mappingsNIS2 Directive vs Canada ITSG-33 — IT Security Risk Management27 mappingsNIS2 Directive vs New Zealand Information Security Manual (NZISM)27 mappingsNIS2 Directive vs MARS-E — Minimum Acceptable Risk Standards for Exchanges27 mappingsNIS2 Directive vs South Korea Cloud Security Assurance Program (CSAP)27 mappingsNIS2 Directive vs NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity27 mappingsNIS2 Directive vs FAA Cybersecurity Framework for Aviation26 mappingsNIS2 Directive vs South Korea ISMS-P26 mappings

Other EU In Vitro Diagnostic Medical Devices Regulation (IVDR) comparisons

Pakistan Personal Data Protection Bill 2023 vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)11 mappingsLaw 1581 of 2012 - Statutory Framework for the Protection of Personal Data vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)11 mappingsGDPR vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)11 mappingsUK GDPR (UK General Data Protection Regulation) vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)11 mappingsGhana Data Protection Act 2012 (Act 843) vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)11 mappingsChile Personal Data Protection Law (Law No. 21.719) vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)10 mappingsEstonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019) vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)10 mappingsKuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive) vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)10 mappings

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What are the key differences between NIS2 Directive and EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?

NIS2 Directive has 80 controls across its framework, while EU In Vitro Diagnostic Medical Devices Regulation (IVDR) covers 43 controls. Direct mapping analysis identifies 21 overlapping controls (26% coverage). The frameworks diverge most significantly in Other, where 14 NIS2 Directive controls have no direct EU In Vitro Diagnostic Medical Devices Regulation (IVDR) equivalent.

How many controls map between NIS2 Directive and EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?

Of 80 total NIS2 Directive controls, 21 map directly to EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls — representing 26% coverage. The remaining 59 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping NIS2 Directive to EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?

59 NIS2 Directive controls have no direct equivalent in EU In Vitro Diagnostic Medical Devices Regulation (IVDR). The highest concentration of gaps is in Other with 14 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 NIS2 Directive and EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?

The domain with the highest gap count is Other (14 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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.