European Union
EU IVDR (Regulation (EU) 2017/746): European Union In Vitro Diagnostic Regulation
The EU In Vitro Diagnostic Regulation governs IVDs placed on the EU market, from reagents and analyzers to software and self-tests. Its biggest practical change is classification: under the old directive most IVDs were self-declared, while under the IVDR a much larger share need a notified body.
At a Glance
- Regulation
- EU IVDR (Regulation (EU) 2017/746)
- Subject
- European Union In Vitro Diagnostic Regulation
- Group
- European Union
- Industries
- 2 industry guides reference it
A plain-language summary, not legal advice. Always read the current official text.
What It Covers
The IVDR classifies devices into four risk classes, A, B, C and D, based on rules that consider the intended purpose, the risk to the individual and the risk to public health. Class D covers the highest public health risks. Apart from non-sterile class A devices, conformity assessment involves a notified body, which means many manufacturers who never worked with one under the directive now do. Companion diagnostics and class D devices involve additional consultation steps in the assessment process.
Manufacturers must show that devices meet the general safety and performance requirements, supported by technical documentation and a performance evaluation. Performance evaluation brings together scientific validity, analytical performance and clinical performance, and it must be kept up to date. Post-market surveillance feeds the performance evaluation through post-market performance follow-up (PMPF), and serious incidents and field safety corrective actions are reported through the vigilance system.
Like the MDR, the IVDR requires a QMS, risk management, a person responsible for regulatory compliance, UDI and use of EUDAMED. Notified bodies conduct initial, surveillance and unannounced audits, with unannounced audits required at least once every five years. Health institutions that make and use devices in-house can rely on an exemption only under the conditions the regulation sets.
Who It Applies To
- Manufacturers placing IVDs on the EU market, including reagents, instruments, software and self-tests
- Manufacturers of companion diagnostics
- IVD makers moving from self-declaration to notified body conformity assessment
- Authorized representatives, importers and distributors of IVDs
- Health institutions using in-house devices, under the regulation's specific conditions
What Auditors Check
Classification Rationale
Whether the device class was assigned by applying the IVDR rules to the intended purpose, with the reasoning documented.
Performance Evaluation
Whether scientific validity, analytical performance and clinical performance are demonstrated with adequate data, and kept current.
Post-Market Performance Follow-Up
Whether PMPF is planned and carried out where needed, and whether the results update the performance evaluation and risk management.
Technical Documentation
Whether documentation is complete and organized to show conformity with the general safety and performance requirements.
Vigilance and Trend Reporting
How serious incidents, field safety corrective actions and trends are identified and reported.
QMS Under the IVDR
Whether the QMS covers IVDR-specific obligations such as the PRRC role, UDI and post-market surveillance, beyond ISO 13485.
Related Services
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AI-Assisted QMS Gap Assessment
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Industry Guides That Reference EU IVDR (Regulation (EU) 2017/746)
Questions
Why do so many more IVDs need a notified body now?
The IVDR replaced the directive's list-based approach with risk-based classification rules. As a result, a much larger share of IVDs fall into classes that require notified body involvement. Only non-sterile class A devices remain self-declared.
What does a performance evaluation include?
It brings together evidence of scientific validity, analytical performance and clinical performance for the device's intended purpose. It is a living document, updated with post-market data including PMPF. The evidence needed depends on the device and its class.
Is the IVDR the same as the MDR for diagnostics?
They share structure and many concepts, such as GSPR, PMS, vigilance, the PRRC and EUDAMED, but the IVDR has its own classification rules and its own clinical evidence model built around performance evaluation. Firms that make both types of products need to apply each regulation to the right devices.
EU IVDR (Regulation (EU) 2017/746)
Check Your Quality System Against EU IVDR (Regulation (EU) 2017/746)
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