EU Quality Management System Certificate

EU Quality Management System Certificate

The Notified Bodies follow the chapter I of Annex IX in MDR for the conformity assessment of the Quality Management System of the medical device manufacturers. If the quality management system conforms to all the obligations of MDR, the Notified Body issue EU Quality Management System Certificate.

It is applicable for all classes of medical devices that require Notified Body intervention for their CE Marking process. This certificate includes clear product identification devices or group of devices), the risk classification, and for Class IIb, intended purpose also. For the Class Is/m/r device, the certificate shall include the statement the limitations to the aspects of the quality management system being audited.

The CE Certificates issued are valid for a maximum of 5 years and will be renewed by annual surveillance audit. The certificate can be suspended, withdrawn, modified, or supplemented under the Notified Bodies perusal.

Is the EU Quality Management System Certificate only required for the Class III medical device as per the conformity assessment procedure? On what all reason a supplement certificate can be issued by the Notified Body?