In Vitro Diagnostic Device Regulation (IVDR) Regulation (EU) 2017/746 on in vitro diagnostic medical devices¶

The In vitro Diagnostic Device Regulation (IVDR) is an EU regulation for in vitro diagnostic medical equipment. The goal of the regulation is to ensure that medical equipment available on the market is safe and secure, and to protect public health by guaranteeing that medical devices are safe to use and perform as intended. This regulation sets specific requirements for products that are to be placed on the European market, ensuring they meet high standards of quality and reliability.

Info

The regulation is publicly available here: https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng
This page was last updated May 27th 2025