Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes of in vitro diagnostic medical devices (IVDs). Manufacturers must demonstrate that the devices conform to relevant requirements based upon objective evidence and analysis.
In accordance with these conformity assessment procedures, in addition to quality management system and technical documentation assessments, notified bodies are required to verify product batches of class D IVDs in line with Annexes IX and XI of the IVDR. Therefore, in order to verify the conformity of class D IVDs, manufacturers should forward to notified bodies the reports on tests carried out on each manufactured batch of class D devices
Furthermore, the manufacturer should make available samples of manufactured class D devices or batches of devices to the notified body in accordance with pre-agreed conditions and detailed arrangements.
The notified body involved in the conformity assessment of class D IVDs should request one of the EU reference laboratories (EURLs), if designated by the European Commission , to carry out batch testing on those devices. The EURL should, in turn, inform the notified body about its findings. Following this verification procedure, manufacturers may place class D IVDs on the market unless the notified body communicates to the manufacturer within an agreed timeframe, but not later than 30 days after reception of the samples, any other decision.
In the absence of a designated EURL for a device, the requirements relating to EURLs do not have to be applied.
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 arrangements5
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