Pathways' Pick of the Week: Batch Testing Begins in the EU

Five Reference Laboratories (EURLs) designed under the IVD Regulation will start carrying out their regulatory responsibilities to perform batch testing and performance verification for select high -risk (Class D) diagnostics October 1. As of that date, notified bodies should start contacting the EURLs to make arrangements to perform batch testing of Class D tests that they’ve certified that fall within the clinical scope of the labs, according to an updated EU guidance published September 25. “It may not be possible to start the testing itself on this date,” the guidance states. “Testing should take place, on a case-by-case basis, as soon as all the arrangements such as proper installation and validation of any equipment are in place.” Notified bodies should also plan to reach out to EURLs to conduct performance verification on relevant Class D tests submitted to the bodies for review from October 1, the guidance explains. These requirements did not kick-in when the IVDR originally took effect in 2022 due to delays in recruiting and designating reference labs. The five designated labs can perform testing for diagnostics for detection or quantification of hepatitis and retrovirus infection, herpesvirus, d bacterial agents, or respiratory virus. They aren’t designated to address the other four IVDR-required clinical areas: arbovirus, hemorrhagic fever, parasites, and blood grouping. 

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