3EC International a.s. designated and notified according to the IVDR

We are pleased to inform you that 3EC International a.s. designation and notification process according to the Regulation (EU) 2017/746 on in vitro diagnostic medical devices was completed with publication of notification in the European Commission`s NANDO database. The current scope of designation and notification according to the Regulation (EU) 2017/746 is available at:




In the following days our webpage will be updated with a section dedicated to the Regulation (EU) 2017/746 with all necessary forms and other mandatory published documents for applicants on conformity assessment according to the new regulation.