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 procedures1, 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 devices2. 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 Commission3, to carry out batch testing on those devices…
