The In Vitro Diagnostic Regulation, Regulation (EU) 2017/746, governs how diagnostic tests, instruments and diagnostic software are placed on the market in the European Union. It replaced the In Vitro Diagnostic Directive and has applied since May 26, 2022.
The IVDR raised the bar significantly: far more products now need a notified body, the evidence required to prove performance is much greater, and manufacturers carry ongoing obligations to monitor their products in the field. This guide explains the regulation in practical terms, drawing on experience CE marking clinical genomics software.
What changed from the old directive
| IVD Directive (IVDD) | IVD Regulation (IVDR) | |
|---|---|---|
| Legal form | Directive, implemented differently in each member state | Regulation, directly applicable across the EU |
| Classification | Lists of specific products | Risk-based Classes A to D under seven rules |
| Notified body involvement | A minority of devices | The large majority of devices |
| Clinical evidence | Limited | Full performance evaluation: scientific validity, analytical and clinical performance |
| Post-market obligations | Basic vigilance | PMS plans, PMPF, PSURs, trend reporting and stricter vigilance |
| Transparency | Limited | UDI, EUDAMED registration and public summaries for higher-risk devices |
Key facts at a glance
| Regulation | (EU) 2017/746 |
| Applies since | May 26, 2022 |
| Legacy device transition | Until the end of 2027, 2028 or 2029 depending on class, subject to conditions |
| EUDAMED | Four modules mandatory since May 28, 2026 |
| Quality system | Required for all manufacturers; ISO 13485 is the standard approach |
| Next change | Targeted revision proposed December 2025, adoption expected around 2027 |
In this guide
Scope and Key Definitions
What counts as an IVD, how software and companion diagnostics are treated, RUO products and in-house tests.
Risk Classification
The four risk classes and the seven classification rules, with examples for genomics.
Conformity Assessment and Notified Bodies
Routes to CE marking by class and how to work effectively with a notified body.
Performance Evaluation
Scientific validity, analytical performance and clinical performance evidence.
Technical Documentation
What Annex II and III require and how to build a file reviewers can navigate.
Post-Market Surveillance and Vigilance
PMS plans, PMPF, PSURs, vigilance reporting deadlines and trend reporting.
Economic Operators, UDI and EUDAMED
Manufacturer, authorized representative, importer and distributor roles, the PRRC, UDI and EUDAMED.
Transition Deadlines and Reform
Legacy device deadlines, in-house device rules and the proposed targeted revision.
Building your quality system? See our ISO 13485 guide.
Need help? Salto Partners guides diagnostics, genomics and medical device companies through ISO 13485 and IVDR. Send us an email and we will set up a conversation.
For general information only; not legal or regulatory advice. Regulations and deadlines change, so confirm current requirements with your notified body or regulatory counsel. Last updated October 2026.