The European Medical Devices Regulation 2017/745 (MDR) is applicable in Europe
Perimed has announced that the company’s products, quality system and manufacturing facility has been certified in accordance with the new European Medical Device Regulation (MDR).
Safety and effectiveness are focus areas for the medical device company. By continuously adapting to meet the quality and regulatory requirements during the product life cycle through an effective and practical quality management system and procedures, we maintain our competitive edge.
I am so proud to have our team deliver on this important milestone without receiving any non-conformances
Lena Åredal, CEO at Perimed, said: “Our vision is to save limbs, lives and reduce human suffering and one of our value statements is to have compliance in everything we do. I am so proud to have our team deliver on this important milestone without receiving any non-conformances.”
The European Medical Devices Regulation 2017/745 (MDR) is applicable in Europe, replacing the Medical Devices Directive (93/42/EEC) and introducing major changes to how medical device manufacturers obtain European market access. This transition involves an increased work effort compared to the previous regulation, since the MDR introduces a life-cycle approach for the CE Marking Compliance and introduces several new requirements.