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What is the risk class of my medical device?
Medical devices are divided into four categories or classes, from the lowest to the highest risk class: I*, IIa, IIb and III. The higher the risk for the patient/end-user, the higher the risk category. Read more about the classes of the medical devices and the changes as of May 2021.
On which part of the medical device must the CE marking be affixed?
CE marking on medical device must appear in a visible, legible, and indelible form on the device or its sterile pack.