MetaSystems and the In Vitro Diagnostics Regulation (IVDR)
On May 26, 2022, the transition period from the In Vitro Diagnostics Directive (IVDD; Directive 98/79/EC) to the In Vitro Diagnostics Regulation (IVDR; Regulation (EU) 2017|746) will end. As of this effective date, the requirements of the new regulation will apply in full. Important changes in the new regulation include the extension of the scope, a new classification system, and the introduction of a unique device identification number.
For this, MetaSystems is preparing CE certification according to IVDR for the new software versions Ikaros 6.3 and Metafer 4.3. The innovations will have some impact on our product structure and update capabilities. This document is intended to help you assess the situation and educate you on the measures to make your MetaSystems device(s) IVDR compliant as smoothly as possible, so that you can benefit from future innovations, for example in the field of artificial intelligence.Read More