EU IVDR Compliance for In-House Lab Developed IVD Tests
- usr192162
- 0
- on Oct 15, 2023
EU IVDR Compliance for In-House Lab Developed IVD Tests When it comes to compliance with European regulations, manufacturers of in-house lab-developed tests have had it pretty good├óΓé¼┬ªalong with most other IVD manufacturers. While the EU├é┬áIn Vitro├é┬áDiagnostic Directive (IVDD 98/79/EC) exempted makers of so-called in-house tests (aka LDT), the new├é┬áIn Vitro├é┬áDiagnostic Regulation does not carve out […]
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