System certification
Management system certification as per international standards.
Product certification IVDR
Conformity assessment of in vitro diagnostic medical devices as per Regulation (EU) 2017/746.
Product certification MDR
Conformity assessment of medical devices as per Regulation (EU) 2017/745.
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3EC International a.s. is dynamic international certification body which is currently accredited by SNAS for several standards in the area of management system certification and Authorized and Notified Body for conformity assessment of medical devices and in vitro medical devices as per European Regulations.
3EC International a. s. has received a prestigious recognition within the Johann Wolfgang von Kempelen Award, granted every three years…
From 28 May 2026, the use of the first four modules of the European database on medical devices, EUDAMED, becomes…