Is your company as far along as it needs to be?
The In Vitro Diagnostics Regulation, or the IVDR, was created to ensure a greater level of patient protection and regulation around the creation of in vitro diagnostic devices (or IVDs). The IVDR will replace the legacy In Vitro Diagnostic Directive (IVDD) and should ensure a greater level of patient protection and provide rules and regulations that are more effectively implemented.
The manufacturers of these devices are well aware of the IVDR that will soon take effect. Most of these manufacturers are already taking the necessary steps to prepare to comply with this new regulation, but are they as far along in their preparations as they should be?