This document aims to provide guidance to notified bodies to clarify their role and responsibilities in relation to samples of manufactured class D devices or batches of devices in accordance with Annexes IX and XI of the IVDR.
This guidance also describes best practices for notified bodies in performing conformity assessment procedures relating to the verification of manufactured class D IVDs.
It also includes guidance on:
• relevant information to be included within the notified body’s procedures,
• the content of the required pre-agreed conditions and detailed arrangements between the notified body and the manufacturer,
• guidance on the frequency of samples of devices or batches of devices to be sent to the EURL
It is understood that the IVDR requirements related to testing every product batch, and consequently this guidance document, are relevant for devices for which the concept of batches is applicable. For example, the concept of batches is not applicable for medical device software. Therefore, the corresponding IVDR batch testing requirements and this guidance document are not relevant to class D medical device software