European Commission

The IMI announced the call in February with an initial budget of €45 million but raised the total funding amount to €72 million.

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.