The new Medical Device Regulation (MDR) entered into force on 26 May 2021
The application of the MDR (EU 2017/745) has started on 26 May 2021 after a four-year transition period. All Class I healthcare devices must comply with the new regulation. The transition period for products complying with the old MDD (Medical Device Directive) will only continue for example for devices that were placed on the market (manufactured) before 26 May 2021 or devices whose compliance with the requirements is certified by so called Notified Body.
The new Medical Device Regulation (MDR) replaces the previous Medical Devices Directive (MDD). The new MDR covers the requirements of the previous Directive and introduces many new obligations for manufacturers, importers and distributors of medical devices. For example, the scope of the regulation will become wider and quality management system will become mandatory for companies.
Preparing for the Medical Device Regulation
Lojer Group has been preparing for the requirements and obligations of the new MDR for a long time. For example, we have had quality management systems in place already for years. Lojer was the first Nordic hospital furniture manufacturer to receive ISO 9001 certification already in 1994. In 2020, the quality management system was expanded to cover also the production of the Kempele site. Lojer has also Quality Management System Certification for Medical Devices ISO 13485. ISO certifications cover the production of all three Lojer plants.
In addition, preparations have been made for Medical Devices Regulation for example by creating and updating processes and documents for medical devices and by hiring new employees to be responsible for the regulation brought by the MDR.
Registrations and healthcare professionals' liability
Lojer has made registrations for the medical devices it manufactures in accordance with Fimea's (The Finnish Medicines Agency) instructions. Information on registered manufacturers and importers can be found in the EU-wide EUDAMED database on medical devices, which also includes information on Lojer.
By law, all healthcare professionals must ensure that devices procured for medical purposes are placed on the market in accordance with the Medical Devices Regulation.
