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Cross-Framework Mapping

EU In Vitro Diagnostic Medical Devices Regulation (IVDR)vsEU Medical Devices Regulation (MDR 2017/745)

See exactly how EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls map to EU Medical Devices Regulation (MDR 2017/745). Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
15
Gaps Found
42%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) maps to EU Medical Devices Regulation (MDR 2017/745) with 42% coverage across 11 directly mapped controls. Analysis of 26 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls identifies 15 compliance gaps — primarily concentrated in IVDR - Making Available + Economic Operators (Ch II).

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

Control Mappings

Showing 11 of 11 mapped controls across 4 domains. Sign up to explore all 323K+ mappings across 700 frameworks.

IVDR - Making Available + Economic Operators (Ch II)(2 mappings)

IVDR-Art.10General obligations of manufacturers (Article 10)
→MDR-Art.10General obligations of manufacturers (Article 10)
IVDR-Art.15Person Responsible for Regulatory Compliance (Article 15)
→MDR-Art.15Person Responsible for Regulatory Compliance (Article 15)

IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)(4 mappings)

IVDR-Art.110Transitional provisions (Article 110 as amended by (EU) 2024/1860)
→MDR-Art.120Transitional provisions (Article 120 as amended by (EU) 2023/607)
IVDR-Art.78Post-market surveillance plan and system (Article 78)
→MDR-Art.83Post-market surveillance system of the manufacturer (Article 83)
IVDR-Art.80_81Periodic Safety Update Report (Article 80 + 81)
→MDR-Art.84_85_86PMS plan + PMS report + Periodic Safety Update Report (Articles 84-86)
IVDR-Art.82_83_84_85_86Vigilance + serious incident reporting + field safety corrective actions (Articles 82-86)
→MDR-Art.87_88_89_90_91_92Vigilance + serious incident reporting + FSCAs + trend reporting (Articles 87-92)

IVDR - Identification + UDI + Registration + EUDAMED (Ch III)(4 mappings)

IVDR-Art.17_18EU declaration of conformity and CE marking (Articles 17-18)
→MDR-Art.19_20EU declaration of conformity and CE marking (Articles 19-20)
IVDR-Art.22_23_24_25Identification within supply chain + UDI system (Articles 22-25)
→MDR-Art.25_27_28Supply-chain identification and UDI system (Articles 25, 27-28)
IVDR-Art.26_27_28Registration of devices and economic operators (Articles 26-28)
→MDR-Art.29_30_31Registration of devices and economic operators (Articles 29-31)
IVDR-Art.29_30Summary of safety and performance + European database (Articles 29-30)
→MDR-Art.32_33Summary of Safety and Clinical Performance + EUDAMED (Articles 32-33)

IVDR - Clinical Evidence + Performance Studies (Ch VI)(1 mappings)

IVDR-Art.56_57_58Performance evaluation, performance studies and additional requirements (Articles 56-58)
→MDR-Art.61_62Clinical evaluation and clinical investigations general requirements (Articles 61-62)

Related Comparisons

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

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs EU Clinical Trials Regulation (CTR 536/2014)3 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 Medical Devices Regulation (MDR 2017/745) comparisons

FDA Quality Management System Regulation (QMSR) vs EU Medical Devices Regulation (MDR 2017/745)3 mappingsGDPR vs EU Medical Devices Regulation (MDR 2017/745)2 mappingsEU Clinical Trials Regulation (CTR 536/2014) vs EU Medical Devices Regulation (MDR 2017/745)2 mappingsEU Cyber Resilience Act vs EU Medical Devices Regulation (MDR 2017/745)1 mappings

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What are the key differences between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and EU Medical Devices Regulation (MDR 2017/745)?

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) has 26 controls across its framework, while EU Medical Devices Regulation (MDR 2017/745) covers 26 controls. Direct mapping analysis identifies 11 overlapping controls (42% coverage). The frameworks diverge most significantly in IVDR - Making Available + Economic Operators (Ch II), where 5 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls have no direct EU Medical Devices Regulation (MDR 2017/745) equivalent.

How many controls map between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and EU Medical Devices Regulation (MDR 2017/745)?

Of 26 total EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls, 11 map directly to EU Medical Devices Regulation (MDR 2017/745) controls — representing 42% coverage. The remaining 15 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 Medical Devices Regulation (MDR 2017/745)?

15 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls have no direct equivalent in EU Medical Devices Regulation (MDR 2017/745). The highest concentration of gaps is in IVDR - Making Available + Economic Operators (Ch II) 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 EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and EU Medical Devices Regulation (MDR 2017/745)?

The domain with the highest gap count is IVDR - Making Available + Economic Operators (Ch II) (5 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

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