Description: The In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) requires certain changes of the device or of the quality system to be notified to the Notified Body whereby the Notified Body must assess if the change requires a supplement to the certificate or a new conformity assessment procedure. The requirements to notify changes under the IVDR are linked to certificate(s) issued for the device:
• Devices with an EU Quality Management System Certificate must apply the notification requirements under Annex IX section 2.4.
• Devices with an EU Technical Documentation Assessment Certificate will need to comply with the applicable part of Annex IX section 4 or section 5.
Although the requirements in the IVDR seems to be straightforward, it may not necessarily be the case in practice, especially when these are complex devices that would go through a complicated conformity assessment process. This is different to the types of changes that are covered under article 110 of the IVDR, for legacy devices that transition into the IVDR.
This presentation is intended to provide clarification on the concept of ‘reportable’ changes to the approved design or to the approved quality system or the product-range covered under IVDR Annex IX. It concerns devices that have CE-marking under IVDR. This presentation will cover the decision tree that manufacturers are expected to follow, when determining whether a change is reportable to the Notified Body or not. It will cover a few practical examples of changes for all kinds of IVD devices that may or may not be considered reportable. And will also cover what activities the Notified Body will undertake to assess the change and determine if and how it may impact the already issued CE Certificate.
This session could also be turned into a panel session together with representatives of industry.
Learning Objectives:
Upon completion, participants will understand the mechanisms for determining the impact of a change in the device and/or QMS on the conformity of an IVD, per IVDR.
Upon completion, participants will understand the steps for submission of reportable changes to an approved design or approved quality management system to the Notified Body, per IVDR.
Upon completion, participants will gain an understanding of how the Notified Body will assess reportable changes and how this may (or may not) affect the CE Certificate.
