Class 11b Medical Device

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:

• Examination and testing of each product or homogenous batch of products (Annex IV)
• Audit of the production quality assurance system (Annex V) ISO 13485:2003 (including Design)
• Audit of final inspection and testing (Annex VI) ISO 13485:2003 (excluding Design & Manufacture)
• Audit of the full quality assurance system (Annex II) ISO 13485:2003

Details about Annex can be obtained from Medical device directive.

More details about process of certification click here .