Legacy IVD devices are IVDs legally CE-marked under the old EU In Vitro Diagnostic Directive (IVDD). They were CE marked before the EU In Vitro Diagnostic Regulation (IVDR) took effect. They are allowed to remain in the market during a defined transition period if...
EU IVDR governs invitro diagnostic devices (IVDs) placed in the EU market. It aims to strengthen patient safety, ensure higher quality standards, and improve transparency compared to the previous directive. Hence, EU IVDR is a major regulatory overhaul that raises the...
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