We are proud to announce that, as the first Notified Body, we have successfully completed the MDR re-notification process in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR).
This significant achievement confirms our professional expertise, technical competence, and our ability to continue providing medical device conformity assessment services at the highest level in compliance with the current requirements of European legislation.
The successful outcome of the process has also been officially confirmed in the European Commission’s NANDO database, where we continue to be listed as Notified Body NB 2265. By successfully maintaining our notification status through the re-notification process, we have demonstrated the continuity of our activities and our long-term readiness to support medical device manufacturers in bringing safe and reliable products to the European market.
For our clients, partners, and stakeholders, this re-notification confirms that the services provided by 3EC International a. s. meet the most stringent requirements imposed on Notified Bodies within the European Union.
We would like to thank all our colleagues, clients and partners for their trust, support, and professional approach, which have been an integral part of achieving this important milestone.
Together, we remain committed to contributing to safety, quality, and innovation in the field of medical devices.