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)
Archive
- Socially Responsible Company 3EC International 20. 08. 2024
- Conditions for extension of the transition period of EC certificates related to the “legacy devices” 28. 03. 2023
- Award for an extraordinary contribution to the development of quality 14. 12. 2022
- Application of IVDR requirements in place of the corresponding requirements of the Directive according to Art. 110 sec. 3 IVDR 06. 10. 2022
- 3EC International a.s. designated and notified according to the IVDR 03. 05. 2022
- Socially Responsible Company 3EC International a.s. 05. 10. 2021
- Application of MDR requirements in place of the corresponding requirements of the Directives according to Art. 120 sec. 3 MDR 01. 06. 2021
- Information about 3EC International trade name misuse 11. 05. 2021
- Socially Responsible Company 3EC International a.s. 25. 11. 2020
- 3EC International a.s. designated and notified according to the MDR 17. 09. 2020
