EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
Regulation (EU) 2017/746 (the IVDR) is the EU horizontal regime for in vitro diagnostic medical devices (IVDs). It applied from 26 May 2022 and replaced Directive 98/79/EC. Regulation (EU) 2024/1860 extended transitional periods for legacy IVDs to 2027-2029 staged by risk class. Key levers: Article 5 placing on the market gating + Article 8/Annex I general safety and performance requirements; Articles 10-15 manufacturer + authorised representative + importer + distributor + Person Responsible for Regulatory Compliance (PRRC) obligations; Article 16 substantial-modification rule; Article 17 EU declaration of conformity + Article 18 CE marking; UDI system (Articles 24-25) and economic-operator registration (Articles 26-28); Article 29 summary of safety and performance + Article 30 European database (EUDAMED); Article 47 risk classification (Class A/B/C/D) + Articles 48-54 conformity assessment routes including Article 50 mechanism for scrutiny of Class D devices; Articles 56-77 performance evaluation + performance studies + Article 59 informed consent (with interventional-clinical-performance studies running alongside the Clinical Trials Regulation); Articles 78-90 post-market surveillance + vigilance + serious incident reporting + Periodic Safety Update Report (PSUR); Articles 92-103 market surveillance + Member-State coordination + Medical Device Coordination Group + EU reference laboratories; Articles 102-104 confidentiality and data protection; Article 110 transitional provisions (as amended by (EU) 2024/1860); Articles 112-113 penalties + entry into force.
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Framework Domains (7)
IVDR - Classification + Conformity Assessment (Ch V)
| Code | Title |
|---|---|
| IVDR-Art.47 | Classification of devices (Article 47 and Annex VIII) |
| IVDR-Art.48_49_50 | Conformity assessment procedures + NB involvement + Class D scrutiny (Articles 48-50) |
| IVDR-Art.51_52_53_54_55 | Certificates of conformity, electronic system, voluntary change of NB, derogations, certificates of free sale (Articles 51-55) |
IVDR - Clinical Evidence + Performance Studies (Ch VI)
| Code | Title |
|---|---|
| IVDR-Art.56_57_58 | Performance evaluation, performance studies and additional requirements (Articles 56-58) |
| IVDR-Art.59_60_61_62 | Informed consent + protection of subjects + emergency situations (Articles 59-62) |
IVDR - Identification + UDI + Registration + EUDAMED (Ch III)
| Code | Title |
|---|---|
| IVDR-Art.17_18 | EU declaration of conformity and CE marking (Articles 17-18) |
| IVDR-Art.22_23_24_25 | Identification within supply chain + UDI system (Articles 22-25) |
| IVDR-Art.26_27_28 | Registration of devices and economic operators (Articles 26-28) |
| IVDR-Art.29_30 | Summary of safety and performance + European database (Articles 29-30) |
IVDR - Introductory Provisions and Scope (Ch I)
| Code | Title |
|---|---|
| IVDR-Art.1_2_3 | Subject matter, definitions and regulatory status (Articles 1-3) |
| IVDR-Art.4 | Genetic information, counselling and informed consent for genetic tests (Article 4) |
IVDR - Making Available + Economic Operators (Ch II)
| Code | Title |
|---|---|
| IVDR-Art.10 | General obligations of manufacturers (Article 10) |
| IVDR-Art.11_12 | Authorised representative and change of authorised representative (Articles 11-12) |
| IVDR-Art.13_14 | Obligations of importers and distributors (Articles 13-14) |
| IVDR-Art.15 | Person Responsible for Regulatory Compliance (Article 15) |
| IVDR-Art.16 | Cases in which obligations of manufacturers apply to others (Article 16) |
| IVDR-Art.5_6_7 | Placing on the market, distance sales and claims (Articles 5-7) |
| IVDR-Art.8_9 | Harmonised standards and common specifications (Articles 8-9) |
IVDR - Notified Bodies (Ch IV)
| Code | Title |
|---|---|
| IVDR-Art.31_32_33 | Notified bodies - authorities, requirements and subsidiaries (Articles 31-33) |
IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)
| Code | Title |
|---|---|
| IVDR-Art.102_103_104 | Confidentiality, data protection and Medical Device Coordination Group cooperation (Articles 102-104) |
| IVDR-Art.110 | Transitional provisions (Article 110 as amended by (EU) 2024/1860) |
| IVDR-Art.112_113 | Penalties and entry into force (Articles 112-113) |
| IVDR-Art.78 | Post-market surveillance plan and system (Article 78) |
| IVDR-Art.80_81 | Periodic Safety Update Report (Article 80 + 81) |
| IVDR-Art.82_83_84_85_86 | Vigilance + serious incident reporting + field safety corrective actions (Articles 82-86) |
| IVDR-Art.92_93_94_95 | Market surveillance and Member-State competent authorities (Articles 92-95) |
Your Compliance Coverage
If you comply with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), you already cover:
EU Medical Devices Regulation (MDR 2017/745)
42%
11 controls mapped
Compare →EU Clinical Trials Regulation (CTR 536/2014)
12%
3 controls mapped
Compare →GDPR
12%
3 controls mapped
Compare →+ 1 more: FDA Quality Management System Regulation (QMSR) (12%)
See all 4 mapped frameworks ↓Maps to 4 other frameworks
Frequently Asked Questions
What is EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) is a compliance framework from European Union with 7 domains and 26 controls. Regulation (EU) 2017/746 (the IVDR) is the EU horizontal regime for in vitro diagnostic medical devices (IVDs). It applied from 26 May 2022 and replaced Directive 98/79/EC. Regulation (EU) 2024/1860 extended transitional periods for legacy IVDs to 2027-2029 staged by risk class. Key levers: Article 5 placing on the market gating + Article 8/Annex I general safety and performance requirements; Articles 10-15 manufacturer + authorised representative + importer + distributor + Person Responsible for Regulatory Compliance (PRRC) obligations; Article 16 substantial-modification rule; Article 17 EU declaration of conformity + Article 18 CE marking; UDI system (Articles 24-25) and economic-operator registration (Articles 26-28); Article 29 summary of safety and performance + Article 30 European database (EUDAMED); Article 47 risk classification (Class A/B/C/D) + Articles 48-54 conformity assessment routes including Article 50 mechanism for scrutiny of Class D devices; Articles 56-77 performance evaluation + performance studies + Article 59 informed consent (with interventional-clinical-performance studies running alongside the Clinical Trials Regulation); Articles 78-90 post-market surveillance + vigilance + serious incident reporting + Periodic Safety Update Report (PSUR); Articles 92-103 market surveillance + Member-State coordination + Medical Device Coordination Group + EU reference laboratories; Articles 102-104 confidentiality and data protection; Article 110 transitional provisions (as amended by (EU) 2024/1860); Articles 112-113 penalties + entry into force. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does EU In Vitro Diagnostic Medical Devices Regulation (IVDR) have?
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) has 26 controls organised across 7 domains. The largest domains are IVDR - Making Available + Economic Operators (Ch II) (7 controls), IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) (7 controls), IVDR - Identification + UDI + Registration + EUDAMED (Ch III) (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does EU In Vitro Diagnostic Medical Devices Regulation (IVDR) map to?
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) maps to 4 other compliance frameworks. The top mapping partners are EU Medical Devices Regulation (MDR 2017/745) (42% coverage), EU Clinical Trials Regulation (CTR 536/2014) (12% coverage), GDPR (12% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with EU In Vitro Diagnostic Medical Devices Regulation (IVDR) compliance?
Start your EU In Vitro Diagnostic Medical Devices Regulation (IVDR) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about EU In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 26 controls and track your progress.
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