Fimet Oy has acquired MDR certificate

The Neo and F1 Arcus devices manufactured by Fimet meet the applicable requirements of the EU Medical Device Regulation (EU 2017/745), which is evidenced by the fact that SGS Fimko Oy, as a notified body (NB 0598), has granted Fimet Oy an MDR certificate. The MDR regulation aims to ensure that medical devices placed on the EU market are safe and effective. The MDR sets significantly more requirements on manufacturers than the previous MDD (Medical Device Directive). This means more requirements for documentation and for the quality management system, and more obligations for manufacturers, distributors and importers.

The MDR brings many significant benefits to users. The purpose of the MDR is to improve patient safety and ensure that devices on the market are of high quality and effective. Devices approved according to the MDR offer users safer, higher-quality and more effective solutions. Transparency, continuous monitoring and strict clinical requirements improve the user experience and reduce risks. The MDR brings confidence not only to patients but also to healthcare professionals, who can trust that the devices they use meet high-class harmonized standards and regulatory requirements.