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 – we have already started an internal project to ensure its fulfillment in 2017.
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
The new EU Medical Devices Regulation 2017/745 (MDR) entered into force after a four-year transitional period ending on May 25, 2021. To avoid market disruption and allow a smooth transition from the Directives to the Regulations, several transitional provisions are in place. Some medical devices with certificates issued under the Previous Directives MDD may continue to be placed on the market until May 27, 2024.
LINET uses this transitional period for ICU beds with scales, which require a specific independent certification for the EU by notified body. TÜV SÜD Product Service GmbH is notified body for LINET products. The other products in the class I medical devices portfolio do not require such certification and are in MDR compliance already since October 2020.
Conformity assessment by a notified body in cooperation with Regulatory and Quality department at LINET has been running since January 2021. Besides the QMS audit the notified body must also review and assess the product technical documentations to verify that they meet the new specific EU requirements. In August 2021 we have already succesfully passed quality system audit according MDR and ICU product review is still in progress. Our target date for the new certificate for ICU beds with scales is March 2022 at latest, until that time these products will be legally placed on the EU market with MDD conformity.