Substantial Change to QMS (Annex IX, Chapter I)

[adir88]

Hi,

Is anyone aware of what constitutes as a substantial change defined in Annex IX, Chapter I of the Regulation?

2.4 The manufacturer in question shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system, or the device-range covered. The notified body shall assess the changes proposed, determine the need for additional audits and verify whether after those changes the quality management system still meets the requirements referred to in Section 2.2. It shall notify the manufacturer of its decision which shall contain the conclusions of the assessment, and where applicable, conclusions of additional audits. The approval of any substantial change to the quality management system or the device-range covered shall take the form of a supplement to the EU quality management system certificate.

For the MDD, I am aware that this was explained in NBOG 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.

MDCG 2020-3 defines "significant change" in the context of Article 120 (legacy MDD devices). Although the principles for changes to device design apply, the MDCG does not include anything regarding changes to the QMS (expected as Article 120 is in Annex II which is on Technical Documentation).

I am wondering what criteria people are using to determine if QMS changes are substantial per the MDR?

Many thanks.