IVDR Resources
Informational guides on Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
This section collects introductory content and useful references to help navigate key concepts, official sources and main topics related to the In Vitro Diagnostic Regulation.
The guides are intended as general orientation resources and, where appropriate, refer to the official texts and updated institutional sources.
Available guides
What is the IVDR? →
Introduction to Regulation (EU) 2017/746. The guide explains what it regulates, what it applies to, the transitional period and the main concepts to know.
Notified Bodies →
What notified bodies are, when they may be involved and what they assess. The guide also explains where to consult the official list in NANDO.
Codes →
Informational overview of the codes used to describe the scope of designation of notified bodies under the IVDR.
Classification Rules →
Introduction to the classification rules set out in Annex VIII of the IVDR and to risk classes A, B, C and D.
Harmonised Standards →
What harmonised standards are and what role they may have. The guide also explains where to consult the official list published by the European Commission.
UDI and Basic UDI-DI →
Informational guide to the UDI system under the IVDR: differences between UDI, UDI-DI, UDI-PI and Basic UDI-DI, traceability, EUDAMED and regulatory documentation.
Post-Market Surveillance →
Informational guide to the PMS system under the IVDR: post-market surveillance plan, PMS report, PSUR, PMPF and vigilance.
The resources in this section are for informational purposes only and do not constitute regulatory, legal, technical or professional advice.
The information is based on publicly available sources and should be read together with the official texts, the updated documentation of the competent authorities and the specific guides referenced on the individual pages.