Medical Device Regulation (MDR)
LINET Group quality policy
In LINET Group we have implemented an integrated management system to ensure the highest possible quality of our products. Its effectiveness is confirmed by independent international certification authorities. The LINET Group manufactures systems are certified in accordance with the internationally recognized ISO 9001:2015, ISO 13485:2016 and ISO 14001:2015 standards. Additionally LINET spol. s r.o. is certified also according to MDSAP requirements. We continuously work to improve internal processes and procedures to ensure compliance and retain a high-class quality management system. Therefore, knowing that a new regulatory – EU Medical Device Regulation (MDR), will be fully applicable since May 2021 – already in year 2017 we have started an internal project, to ensure its fulfillment.
We are proud to inform you that LINET spol. s r.o. and Borcad Medical a.s. with their Class I Medical devices are already in compliance with MDR from 15th October 2020.
EU Medical Device Regulation (MDR)
The new regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, which was published on 25 May 2017, will replace the current Directive 93/42/EEC on medical devices (MDD). The MDR introduces new and stricter requirements for the placement of medical devices and their distribution within the EU with the main goal to improve clinical safety and traceability of all medical devices. It also introduces the new central European Database on Medical Devices (EUDAMED), where all medical devices placed on the EU market will be registered, and much more. This affects everyone that conducts business within the medical device industry in the EU.
Our approach, remaining steps
For LINET Group, this meant that the new regulation must be implemented for all products placed on the EU market. It was required to revise and update all product related processes and documents. Currently a review and preparation of technical documentation of remaining Class I Medical devices produced by company wissner-bosserhoff GmbH and communication with suppliers and distributors are underway. This work which is led in all companies within our Group - LINET spol. s r.o., Borcad Medical a.s., wissner-bosserhoff GmbH as well as all European LINET´s subsidiaries, is processing well and according to the plan to be in compliance with MDR before 26.5.2021.