EU IVDR 2017/746: Overview of Regulation Changes

The In Vitro medical devices faced the implementation of the European Community Directive 98/79/EC in 1998. The In Vitro Diagnostic Directive (IVDD) 98/79/EC has been now transformed to In Vitro Diagnostic Regulation (IVDR) 2017/746/EU. The official timeline for this transition phase to complete implementation is 5 years (26th May 2022). The current regulatory framework for…