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.