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EURLs Go Live: A New Era For High-Risk IVDs

 
• By Amanda Maxwell

There is to be more rigorous testing from now on for high-risk IVDs. Measures are also in place to prevent device shortages during the transition to new rules.

Tube with red liquid labelled 'HBV', hepatitis B blood test concept.
Hepatitis Tests Are Among Those Now Subject To More Stringent EU Oversight

As of 1 October, EU reference laboratories (EURLs) must now conduct performance verification of high-risk IVDs as part of pre-market assessment and be involved in their batch release for four categories of Class D IVDs: hepatitis and retroviruses, herpes viruses, bacterial agents, and respiratory viruses that cause life-threatening diseases.

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More from Geography

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• By Elizabeth Orr

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