Scientific Validity Reports: a mandatory requirement for In Vitro Diagnostic Regulation (IVDR)
In vitro diagnostics (IVDs) play a critical role in diagnosis, proper treatment decisions, and monitoring patient outcomes. The European Union’s new In Vitro Diagnostic Regulation (IVDR) introduces significant changes for IVD manufacturers, necessitating a comprehensive understanding of the regulatory approval requirements to market a product in Europe. The requirements now include clinical and scientific evidence to support the validity of the IVD, as has been standard for reviews of therapeutic products for many years. Manufacturers should familiarize themselves with the key regulatory changes and adhere to the transition timelines specified by the IVDR to ensure compliance and continued access to the European market for their IVDs.
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