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 new guidance concerns the technical assessment of certain devices under the IVDR, which is slated to come into force in May 2022.
The company's Accu-Check SugarView app determines blood glucose ranges without a blood glucose meter by taking photos with a smartphone camera.
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.
The Eudamed database is an integral part of the new Medical Device and IVD Regulations that go into effect in 2020 and 2022.
The Berlin-based company is the first to be designated and more NBs expect they will be designated by year end.
Investigators at the Foundation for Research and Technology - Hellas, a Greek research institute, are coordinating the effort.
Specific Diagnostics said it plans to apply CE marking to the Reveal system next year, followed by submission to the FDA for 510(k) clearance.
With the significant overhaul of the European regulatory landscape underway, some fear it may disproportionately affect small and medium-sized IVD companies.