LINET products are already in compliance with the MDR
LINET, the largest European manufacturer of healthcare beds, is one of the key players in the field of healthcare devices. The company now demonstrates that it is a professional and reliable partner by being one of the subjects on the market already in compliance with the new European Union regulation on medical devices.
MDR (Medical Device Regulation) is a new EU regulation on healthcare products (EU 2017/745) which came into force at the end of May 2017.
After three years of intensive work, LINET with its Class I medical products has been in compliance with the MDR since October 15, 2020. Customers and business partners can thus safely continue planning investments in the safe and high-quality LINET products.
The aim of the MDR is to ensure a smooth functioning of the internal market based on a high level of protection of patients and users, taking into account also small and medium-sized enterprises operating in this field. At the same time, it sets high standards for the quality and safety of medical devices in order to solve general safety issues connected with the products.
Due to the worldwide coronavirus pandemic SARS-CoV-2, the application of the MDR was postponed for a year – it will take effect in May 26, 2021. In these difficult times, the postponement of the regulation is intended to prepare the availability of medical devices on the market, including those that are fundamentally important in the fight against COVID-19, and alleviate the current burden on member states' administrations, healthcare facilities and involved economic operators. Postponing the MDR aims to prevent jeopardization of the proper and timely implementation of the MDR requirements and the smooth functioning of the internal market.
More information: www.linet.com/en/about-us/quality-environment/mdr