Seegene Obtains IVDR Certification for 30 Diagnostic Assays

The IVDR was established to raise quality standards and ensure that existing European In Vitro Diagnostic Medical Device Directive (IVDD) devices are safe. Seegene has proactively responded to recent regulatory changes and secured the mandatory certification. All manufacturers of in vitro diagnostic devices, such as PCR diagnostic assays, must obtain IVDR certification before selling these medical devices in the European market. The IVDR was established to raise quality standards and ensure...

The IVDR was established to raise quality standards and ensure that existing European In Vitro Diagnostic Medical Device Directive (IVDD) devices are safe. Seegene has proactively responded to recent regulatory changes and secured the mandatory certification. All manufacturers of in vitro diagnostic devices, such as PCR diagnostic assays, must obtain IVDR certification before selling these medical devices in the European market.

The new regulation aims to increase the effectiveness and safety of medical devices in the EU. The manufacturers must now follow the requirements for post-market surveillance, clinical evidence, and performance evaluation for all medical devices.

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