TÜV SÜD designated as Notified Body under the IVDR |

The Central Authority of the German Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) has now designated TÜV SÜD Product Service as a Notified Body under the new In Vitro Diagnostics Regulation (IVDR). The IVDR regulates market access and monitoring of in vitro diagnostic medical devices and their accessories placed on the EU market. The new regulation came into force in 2017. Products which are already approved must be recertified by 26 May 2022.