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June 4, 2024


The EU regulates medical laboratories – Are Laboratory Developed Tests still allowed?

By Ulrich HafenJune 4, 20242 Comments

This article will help you ensure that you will still be able to offer in-house IVD (also called Laboratory Developed Tests, LDTs) under the IVDR and will explain the three options open to you avoiding legal disputes. In-house IVD are a type of in vitro diagnostic test. But do regulatory requirements such as the IVDR also…

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