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 The certificate can be suspended, withdrawn, modified, or supplemented under the Notified Bodies perusal.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?
Quality Management System must be followed by manufacturer of all class of device i.e Class I, Class Is, Class Im, Class Ir , Class IIa, Class IIb, Class III.
Quality Management Certificate is mandatory for class IIa, Class IIb, and class III medical device as per conformity assessment procedure to conduct surveillance by notified body to ensure that the manufacturer duly fullfils the obligations arising from the approved quality management system. When there are substantial changes to the quality management system or change in the device-range covered, a supplement certificate can be issued by notified body.
I have agreed with the points mentioned by the responder and in addition, the Surveillance assessment applicable to class IIa, Class IIb, and Class III devices. In the case of class III devices, the surveillance assessment shall also include a test of the approved parts and/or materials that are essential for the integrity of the device, including, where appropriate, a check that the quantities of produced or purchased parts and/or materials correspond to the quantities of finished devices. The notified body shall randomly perform at least once every five years unannounced audits on the site of the manufacturer.
Based on the result of the surveillance, a decision on the verification of the validity of the certificate is issued, or decision on suspension of the certificate. If there are deviations from the requirement, the certificate may be cancelled in extreme cases. If the notified body finds a divergence between the sample taken from the devices produced or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose restrictions on it.
EU Quality Management System Certificate can be issued for Class IIa, Class IIb, Class III and for
Class I devices that are placed on the market in sterile condition (Class Is), having a measuring function (Class Im) or are reusable surgical instruments(Class Ir).
As per Chapter I of Annex XII of EU MDR,
EU quality management system certificates for class I devices for which the involvement of a notified body is required pursuant to Article 52(7) should include a statement that the audit by the notified body of the quality management system was limited to the aspects required under that paragraph.
As per Section 2.4, Chapter I of Annex IX of EU MDR,
If there are any substantial changes planned by the manufacturer to the quality management system, or the device-range covered, upon request from the manufacturer, the notified body should assess the proposed changes, and determine the need for additional audits and verify whether after those changes the quality management system still meets the requirements. If satisfied, the approval of any substantial change to the quality management system or the device-range covered should take the form of a supplement to the EU quality management system certificate.
And as per Chapter I of Annex XII of EU MDR,
Where a certificate is supplemented, modified or re-issued, the new certificate should contain a reference to the preceding certificate and its date of issue with identification of the changes.