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Cross-Framework Mapping

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

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

11
Controls Mapped
15
Gaps Found
42%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

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

Source: TheArtOfService Knowledge Graph | 26 controls analysed | 701 frameworks | 341K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 4 domains. Sign up to explore all 341K+ mappings across 701 frameworks.

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

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

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

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

MDR - Identification, UDI, Registration and EUDAMED (Ch III)(4 mappings)

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

MDR - Clinical Evaluation + Clinical Investigations (Ch VI)(1 mappings)

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

Related Comparisons

Other EU Medical Devices Regulation (MDR 2017/745) comparisons

EU Medical Devices Regulation (MDR 2017/745) vs FDA Quality Management System Regulation (QMSR)3 mappingsEU Medical Devices Regulation (MDR 2017/745) vs GDPR2 mappingsEU Medical Devices Regulation (MDR 2017/745) vs EU Clinical Trials Regulation (CTR 536/2014)2 mappingsEU Medical Devices Regulation (MDR 2017/745) vs EU Cyber Resilience Act1 mappings

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

EU Clinical Trials Regulation (CTR 536/2014) vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)3 mappingsGDPR vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)3 mappingsFDA Quality Management System Regulation (QMSR) vs EU In Vitro Diagnostic Medical Devices Regulation (IVDR)3 mappings

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

EU Medical Devices Regulation (MDR 2017/745) has 26 controls across its framework, while EU In Vitro Diagnostic Medical Devices Regulation (IVDR) covers 26 controls. Direct mapping analysis identifies 11 overlapping controls (42% coverage). The frameworks diverge most significantly in MDR - Making Available + Economic Operators (Ch II), where 4 EU Medical Devices Regulation (MDR 2017/745) controls have no direct EU In Vitro Diagnostic Medical Devices Regulation (IVDR) equivalent.

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

Of 26 total EU Medical Devices Regulation (MDR 2017/745) controls, 11 map directly to EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 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 Medical Devices Regulation (MDR 2017/745) to EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?

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

The domain with the highest gap count is MDR - Making Available + Economic Operators (Ch II) (4 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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