| Theme | Conformity assessment |
| Target Audience | Notified bodies |
| Products Concerned | Class D IVD |
| Documents mentioned |
IVDR (EU) 2017/746 MDCG 2020-16 rev.1 |
The MDCG 2022-3 guidance specifies the role and responsibilities of Notified Bodies in the verification of batches or samples of class D IVDs in accordance with Annexes IX and XI of the IVDR. Indeed, the conformity assessment procedure for the highest risk class IVDs has the particularity to include this additional step.
The Notified Body involved must then ask one of the EU Reference Laboratories designated by the European Commission to perform tests on these batches of devices. Section 5 of this guidance helps the Notified Body to determine the number of initial samples and the testing frequency to be carried out based on the risks associated with the device in a given indication of use.