Class 11 b device are critical compared to class 11a devices. Design related documents are mandatory along with Medical Device Quality Management System implementation (ISO 13485:2003) and Clinical investigation documents. Conformity assessment by a Notified Body is required before affixing CE Mark.
Class 11b CE Marking can be achieved in the following methods:
Details about Annex can be obtained from Medical device directive.
More details about process of certification click here .