EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
The EU In Vitro Diagnostic Regulation (EU 2017/746) establishes the regulatory framework for IVD medical devices in the European Union. Effective May 26, 2022 (with transitional provisions through 2028), it replaces the IVD Directive 98/79/EC. IVDR introduces a new risk-based classification system (Class A-D), strengthened conformity assessment, and enhanced post-market surveillance requirements.
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Framework Domains (6)
Clinical Evidence and Performance
| Code | Title |
|---|---|
| Art. 56 | Data Breach Notification |
| Art. 57 | Transitional Provisions |
| Art. 58 | Scientific Research Data |
| Art. 70 | Criminal Penalties for False Consent |
Identification, Traceability and Registration
| Code | Title |
|---|---|
| Art. 22 | Suspension and Revocation |
| Art. 26 | Outsourcing of Personal Information Processing |
| Art. 28 | Administrative Measures |
| Art. 29 | Safety Measures |
Introductory Provisions
| Code | Title |
|---|---|
| Art. 1 | Open Finance Implementation |
| Art. 2 | Consent Definition |
| Art. 4 | Participating Institutions |
Market Placement and Economic Operators
| Code | Title |
|---|---|
| Art. 13 | Data Security and Privacy |
| Art. 14 | Direct Data Flows |
| Art. 5 | Legal Recognition of Data Messages |
| Art. 9 | Free Data Sharing |
Notified Bodies and Conformity Assessment
| Code | Title |
|---|---|
| Art. 31 | Designation of Chief Privacy Officer |
| Art. 47 | Existing Legal Procedures |
| Art. 48 | Criminal Penalties |
| Art. 52 | Appropriate Safeguards |
Post-Market Surveillance and Vigilance
| Code | Title |
|---|---|
| Art. 78 | Inspection Powers |
| Art. 82 | Inspection Procedure |
| Art. 87 | Administrative Fines |
| Art. 95 | Inspection Supervision |
Maps to 610 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 6 domains and 23 controls. The EU In Vitro Diagnostic Regulation (EU 2017/746) establishes the regulatory framework for IVD medical devices in the European Union. Effective May 26, 2022 (with transitional provisions through 2028), it replaces the IVD Directive 98/79/EC. IVDR introduces a new risk-based classification system (Class A-D), strengthened conformity assessment, and enhanced post-market surveillance requirements. 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 23 controls organised across 6 domains. The largest domains are Clinical Evidence and Performance (4 controls), Identification, Traceability and Registration (4 controls), Market Placement and Economic Operators (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 610 other compliance frameworks. The top mapping partners are Pakistan Personal Data Protection Bill 2023 (48% coverage), UK GDPR (UK General Data Protection Regulation) (48% coverage), Ghana Data Protection Act 2012 (Act 843) (48% 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 23 controls and track your progress.
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