This is to inform that on-site assessment according to the Art. 39 sec. 4 of the Regulation (EU) 2017/745 on medical devices (MDR) was conducted at 3EC International a.s. by Joint assessment team and Authority responsible for notified bodies in first week of June 2019. The designation and notification process is progressing well and currently we may assume its completement before MDR enters into force in May 2020.
On-site joint assessment conducted at 3EC International a.s. as per Regulation (EU) 2017/745 on medical devices (MDR)