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Lasix® ONYU[1] Achieves CE Marking under EU Medical Device Regulation, Reaching a Critical Milestone Toward International Market Authorization; European Medicines Agency Confirms Eligibility for Centralized Procedure Review Based on Technical Innovation

B CE Marking confirms the device’s conformity with EU Medical Device Regulation (MDR 2017/745) General Safety and Performance Requirements (GSPRs) EMA centralized procedure acceptance on the basis of technical innovation expedites European process of Market Authorization. BURLINGTON, Mass., April 28,…