The IVDR also introduces changes in the classification and risk assessment of in vitro diagnostic devices. Manufacturers must meticulously assess the risk profile of their products, which may lead to reclassification and the need to modify device labeling and documentation accordingly. These demands have increased the compliance burden, demanding a significant investment of time and resources.
The IVDR also champions transparency. Manufacturers are required to furnish comprehensive information on device performance, clinical evidence and instructions for use. This enhanced transparency equips users with richer data, enabling more informed decision-making in clinical practice. Moreover, the regulation emphasizes post-market surveillance and reporting, which should lead to improved data quality. This is anticipated to raise the overall quality of diagnostics, ultimately resulting in improved patient care.
Join this webinar to learn how the new In Vitro Diagnostic Regulation (IVDR) impacts manufacturers and users of diagnostic devices.
Join experts from Cerba Xpert, Dr. Sébastien Barradeau, Global Head of IVD Medical Device; and Marie-Laure Delalande, Head of IVD Operations, for the live webinar on Tuesday, January 9, 2024, at 10am EST (4pm CET/EU-Central).
For more information, or to register for this event, visit Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users.
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