The EU In Vitro Diagnostic Regulation 2017/745-746 (EU IVDR) replaces the In Vitro Diagnostic Directive (IVDD) and will be applicable to most IVDs sold in Europe. Regardless of whether you have been selling regulated IVDs in Europe for many years, or your diagnostic devices are newly regulated by the IVDR, you need to understand the gaps in your compliance. This gap analysis spreadsheet is just the tool to help you do that!