Cross-Framework Mapping

EU In Vitro Diagnostic Medical Devices Regulation (IVDR)vsEstonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)

See exactly how EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls map to Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019). Pre-computed mappings, identified gaps, and coverage analysis.

24
Controls Mapped
0
Gaps Found
43%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) maps to Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019) with 43% coverage across 10 directly mapped controls. Analysis of 23 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls identifies 13 compliance gaps — primarily concentrated in Post-Market Surveillance and Vigilance.

Source: TheArtOfService Knowledge Graph | 23 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 20 of 24 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Introductory Provisions(6 mappings)

Art. 2Consent Definition3 targets
Art. 4Participating Institutions
Sec. 2Interpretation
Sec. 3Scope and Application
Art. 4Participating Institutions3 targets
Art. 2Consent Definition
Sec. 2Interpretation
Sec. 3Scope and Application

Identification, Traceability and Registration(7 mappings)

Art. 26Outsourcing of Personal Information Processing3 targets
152FZ-1Scope of the Federal Law (Article 1)
EPDPA-1Scope of Regulation (§1)
Sec. 2Interpretation
Art. 28Administrative Measures
EPDPA-19Supervisory Authority (§51–§55)
Art. 29Safety Measures3 targets
152FZ-1Scope of the Federal Law (Article 1)
EPDPA-1Scope of Regulation (§1)
Sec. 2Interpretation

Notified Bodies and Conformity Assessment(6 mappings)

Art. 47Existing Legal Procedures3 targets
152FZ-1Scope of the Federal Law (Article 1)
EPDPA-1Scope of Regulation (§1)
Sec. 2Interpretation
Art. 48Criminal Penalties3 targets
EPDPA-16Data Protection Specialist (§40–§42)
EPDPA-19Supervisory Authority (§51–§55)
EPDPA-21Violations and Proceedings (§62–§73)

Clinical Evidence and Performance(1 mappings)

Art. 56Data Breach Notification
EPDPA-17Security Measures and Breach Notification (§43–§45)

+4 more mappings

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Related Comparisons

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

Other Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019) comparisons

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What are the key differences between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)?

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) has 23 controls across its framework, while Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019) covers 34 controls. Direct mapping analysis identifies 10 overlapping controls (43% coverage). The frameworks diverge most significantly in Post-Market Surveillance and Vigilance, where 4 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls have no direct Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019) equivalent.

How many controls map between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)?

Of 23 total EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls, 10 map directly to Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019) controls — representing 43% coverage. The remaining 13 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping EU In Vitro Diagnostic Medical Devices Regulation (IVDR) to Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)?

13 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls have no direct equivalent in Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019). The highest concentration of gaps is in Post-Market Surveillance and Vigilance 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 In Vitro Diagnostic Medical Devices Regulation (IVDR) and Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)?

The domain with the highest gap count is Post-Market Surveillance and Vigilance (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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.