Getting Ahead of the IVDR Tsunami

The transition to the In Vitro Diagnostic Regulation (IVDR) marks a pivotal moment for the in vitro diagnostics (IVD) industry. This new regulatory framework, implemented in the European Union, has been introduced to address the evolving landscape of diagnostic technologies and patient safety. Compared to the 20 year old In Vitro Diagnostic Directive (IVDD), the IVDR has ushered in stricter and more standardized regulations to ensure the safety, efficacy, and quality of IVD devices. It hasn’t been an easy transition.

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