Calmark extends the time plan for CE-mark of the biomarkers LDH and Glucose - market launch as according to plan
Calmark Sweden AB (publ) announces today that the Company's products for biomarkers, LDH and glucose, will not obtain their CE conformity markings until the first quarter of 2020, the market launch of products will not be affected. The Company has focused its efforts on the first biomarker, bilirubin, whose CE-mark is on schedule, and on ramping up the production lines to facilitate market launch. As a consequence, the projects for the other biomarkers have lagged behind slightly. The update of the IVDR regulatory requirements, which will go into effect in 2022, has also had an impact,