IVD manufacturers are hoping questions related to the UK's pending exit from the EU, as well as the new European IVD Regulation, will soon be resolved.
The 46-page document advises test makers on how to best implement cybersecurity measures under the new regulation, which is set to go into effect in 2022.
The tubes and collection kits meet the requirements of the European In-Vitro Diagnostic Devices Directive, and the company can now commercialize the devices throughout Europe.
With the significant overhaul of the European regulatory landscape underway, some fear it may disproportionately affect small and medium-sized IVD companies.
