Europe Union | Medical Devices |IVD Devices | IVD| CE Mark Registration | Active Implan... - 0 views
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arazy-group on 22 Sep 11Medical devices are divided into class I, IIa, IIb and III. IVDs are divided into four categories: General IVDs, self-diagnostics, list A and list B. All medical devices exempt class I and General IVDs require the involvement of a Notified Body and the implementation of a quality management system, usually in line with ISO 13485.