EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
The EU In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746) establishes a comprehensive regulatory framework for in vitro diagnostic medical devices in the European Union. It became applicable on May 26, 2022, replacing the previous IVD Directive (98/79/EC). The IVDR introduces a risk-based classification system for devices, enhanced clinical evidence requirements, improved traceability through UDI, and stricter oversight of manufacturers and notified bodies. Transitional provisions extend until 2028 for certain devices to ensure market continuity.
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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 |
Your Compliance Coverage
If you comply with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), you already cover:
Pakistan Personal Data Protection Bill 2023
48%
11 controls mapped
Compare →UK GDPR (UK General Data Protection Regulation)
48%
11 controls mapped
Compare →Ghana Data Protection Act 2012 (Act 843)
48%
11 controls mapped
Compare →+ 607 more: Chile Personal Data Protection Law (Law No. 21.719) (43%), Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019) (43%)
See all 610 mapped frameworks ↓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 Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746) establishes a comprehensive regulatory framework for in vitro diagnostic medical devices in the European Union. It became applicable on May 26, 2022, replacing the previous IVD Directive (98/79/EC). The IVDR introduces a risk-based classification system for devices, enhanced clinical evidence requirements, improved traceability through UDI, and stricter oversight of manufacturers and notified bodies. Transitional provisions extend until 2028 for certain devices to ensure market continuity. 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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