EU Medical Device Regulation (MDR)
Quality Policy of the LINET Group
In the 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 bodies. The manufacturing processes of the LINET Group are certified according to the internationally recognized standards ISO 9001:2015, ISO 13485:2016 and ISO 14001:2015. We work continuously to improve our internal processes and procedures to ensure compliance with regulations and maintain a first-class quality management system. In preparation for the new EU Medical Device Regulation (MDR), which will be fully applicable as of May 2020, we started an internal project as early as 2017 to ensure its compliance.
EU Medical Device Regulation (MDR)
The new Regulation (EU) 2017/745 of the European Parliament and Council concerning medical devices, which was published on May 25, 2017, will replace the current Medical Devices Directive 93/42/EEC (MDD). MDR introduces new and stricter requirements for the positioning of medical devices and their distribution within the EU with the main objective of improving the traceability and clinical safety of all medical devices.
Our promise
We can assure you that all our products put into circulation after May 26, 2020, will comply with the requirements of the new EU Medical Devices Regulation. Products placed on the market in accordance with the previously valid Directive 93/42/EEC before May 26, 2020, may continue to be made available or put into operation until May 27, 2025.
Please do not hesitate to contact us if you have any questions regarding these topics.
Additional information
More detailed information about the MDR can be found on the following page:
