Everything you need to know about In Vitro Diagnostic Regulation – (IVDR)
The “In Vitro Diagnostic Regulation” (IVDR) is a new regulation by the EU applicable for In Vitro Diagnostic (IVD) Medical Devices. The IVDR came into effect on May 25, 2017, with a five-year transition period for manufacturers and suppliers. The new regulation replaces the In Vitro Diagnostics Directive (IVDD) 98/79/EC. The new regulation is significant […]