We use cookies on our website to personalize content and ads, to provide social media features and to analyze traffic to our website. To provide you with a convenient online experience and to improve our communications, please click "ACCEPT ALL". By doing so, you consent to the processing and sharing of your information with our social media, advertising and analytics partners. You can revoke your consent at any time in the settings.
Data protection declaration | Legal notices
Setting

In vitro Diagnostics Directive (IVDD)

In vitro diagnostic devices are used to test tissue samples or bodily fluids. All in vitro diagnostic (IVD) devices sold in the European Union need to have a CE marking. The main objective of this is to make sure patients and users can rest assured that the products are safe for use. With the mark, the manufacturer shows that a device complies with all the relevant regulations. IVD devices are becoming more complex due to technological developments and other improvements. By conforming to the IVDD, the devices remain safe for use on patients even during times of continuous innovation. DEKRA has been officially designated to review the compliance of products to the essential requirements of the IVDD for access to the EU market.

Transition from IVDD to IVDR

The IVDR regulation was published on May 25, 2017, and the transitional period will run until 2022. The scope of the IVDR has been extended to include additional devices. At DEKRA, we have hosted webinars about this topic to inform customers about the transition to the IVDR.
Contact us