TheArtOfService
Cross-Framework Mapping

EU In Vitro Diagnostic Medical Devices Regulation (IVDR)vsEU Clinical Trials Regulation (CTR 536/2014)

See exactly how EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls map to EU Clinical Trials Regulation (CTR 536/2014). Pre-computed mappings, identified gaps, and coverage analysis.

5
Controls Mapped
21
Gaps Found
12%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) maps to EU Clinical Trials Regulation (CTR 536/2014) with 12% coverage across 3 directly mapped controls. Analysis of 26 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls identifies 23 compliance gaps — primarily concentrated in IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X).

Source: TheArtOfService Knowledge Graph | 26 controls analysed | 700 frameworks | 323K+ cross-framework mappings

Control Mappings

Showing 5 of 5 mapped controls across 2 domains. Sign up to explore all 323K+ mappings across 700 frameworks.

IVDR - Introductory Provisions and Scope (Ch I)(1 mappings)

IVDR-Art.4Genetic information, counselling and informed consent for genetic tests (Article 4)
→CTR-Art.29Informed consent (Article 29)

IVDR - Clinical Evidence + Performance Studies (Ch VI)(4 mappings)

IVDR-Art.56_57_58Performance evaluation, performance studies and additional requirements (Articles 56-58)2 targets
→CTR-Art.28General rules on subject protection (Article 28)
→CTR-Art.41_42Adverse-event and SUSAR reporting (Articles 41-42)
IVDR-Art.59_60_61_62Informed consent + protection of subjects + emergency situations (Articles 59-62)2 targets
→CTR-Art.29Informed consent (Article 29)
→CTR-Art.31_32Trials on incapacitated subjects and minors (Articles 31-32)

Related Comparisons

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

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs EU Medical Devices Regulation (MDR 2017/745)11 mappingsEU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs GDPR3 mappingsEU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs FDA Quality Management System Regulation (QMSR)3 mappings

Other EU Clinical Trials Regulation (CTR 536/2014) comparisons

ICH E6(R3) - Good Clinical Practice vs EU Clinical Trials Regulation (CTR 536/2014)8 mappingsGDPR vs EU Clinical Trials Regulation (CTR 536/2014)4 mappingsEU Medical Devices Regulation (MDR 2017/745) vs EU Clinical Trials Regulation (CTR 536/2014)2 mappings

Stop Paying Consultants to Read Spreadsheets

AI-powered compliance intelligence across 700 frameworks — at a fraction of consulting costs.

$0/forever

Free

  • ✓ 700 framework browser
  • ✓ Cross-framework mappings (323K+)
  • ✓ 824 compliance assessments
  • ✓ 3 AI queries & searches per day
Get Started Free
Recommended
$49/month

Professional

  • ✓ Unlimited AI Compliance Advisory
  • ✓ Unlimited full-text search
  • ✓ Framework self-assessment
  • ✓ PDF, Excel & CSV exports
Start 7-Day Free Trial →

Popular framework comparisons

NIST CSF vs NIST 800-53ISO 27001 vs NIST CSFCMMC vs NIST 800-53FedRAMP vs NIST 800-53NIST CSF vs SOC 2HIPAA vs NIST 800-53ISO 27001 vs SOC 2ISO 27001 vs ISO 27701

What are the key differences between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and EU Clinical Trials Regulation (CTR 536/2014)?

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) has 26 controls across its framework, while EU Clinical Trials Regulation (CTR 536/2014) covers 30 controls. Direct mapping analysis identifies 3 overlapping controls (12% coverage). The frameworks diverge most significantly in IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X), where 7 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls have no direct EU Clinical Trials Regulation (CTR 536/2014) equivalent.

How many controls map between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and EU Clinical Trials Regulation (CTR 536/2014)?

Of 26 total EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls, 3 map directly to EU Clinical Trials Regulation (CTR 536/2014) controls — representing 12% coverage. The remaining 23 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 EU Clinical Trials Regulation (CTR 536/2014)?

23 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls have no direct equivalent in EU Clinical Trials Regulation (CTR 536/2014). The highest concentration of gaps is in IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) with 7 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 EU Clinical Trials Regulation (CTR 536/2014)?

The domain with the highest gap count is IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) (7 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.