All CE certificates within the scope of the Regulation will expire. In this process, medical device manufacturers will be requested to declare that the conditions for additional time are met. In addition, confirmation letters must be obtained from authorized Notified Bodies. Please inquire whether the products we use and purchased after the relevant date have extended their existing certificates or whether they are certified by the notified body according to the new Medical Device Regulation (2017/745).
Tags: MDR, medical device, 2017/745.