EU IVDR Compliance for Makers of Laboratory-Developed Tests (LDT) and In-House IVD Tests (IH-IVDs)

When it comes to compliance with European regulations, manufacturers of in-house lab-developed tests (LDTs or IH-IVDs, which stands for in-house in vitro diagnostics) have had it pretty good…along with most other IVD manufacturers. That is about to end on May 26, 2022. While the EU In Vitro Diagnostic Directive (IVDD 98/79/EC) exempted makers of so-called in-house tests (aka LDTs), the new In Vitro Diagnostic Regulation (IVDR 2017/746 download) does not carve out many exemptions for these tests. Still, without a […]

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