When would an EURL (European Union Reference Laboratories) be involved in the conformity assessment of an IVD?

The involvement of an EURL is mandatory under IVDR 2017/746 for Class D IVDs. EURLs verify the performance of Class D devices and compliance with common specifications, and performance batch testing of Class D devices.

Article 100 of IVDR 2017/746 provides more information on EURLs, including listing their tasks. Commission Implementing Regulation (EU) 2022/948 also provides the tasks and criteria for EURLs.