What is IVDR and What is its Legal Regulation? | Scilife

The IVDR EU Regulation 2017/746 is – like the name already implies – related to In Vitro Diagnostic Medical Devices. This European regulation has come into effect on May 26, 2022 to guarantee the smooth functioning of internal markets for In Vitro Diagnostic Devices by establishing a robust, transparent, predictable, and sustainable regulatory framework that supports innovation. The IVDR repeals and replaces IVDD 98/97/EC directive and is widely considered to be more comprehensive than its...