Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users, Upcoming Webinar Hosted by Xtalks

In this free webinar, learn how the new In Vitro Diagnostic Regulation (IVDR) impacts manufacturers and users of diagnostic devices. Attendees will learn the specific compliance requirements, risk assessments and quality management changes mandated by the IVDR. The featured speakers will discuss the benefits of enhanced patient safety, transparency and improved diagnostic data for users.

TORONTO, Dec. 12, 2023 /PRNewswire-PRWeb/ -- The implementation of the new In Vitro Diagnostic Regulation (IVDR) within the European Union (EU) has introduced profound changes with far-reaching impacts on both manufacturers and users of in vitro diagnostic devices.

Manufacturers operating within the EU are facing a vastly different regulatory landscape with the advent of the IVDR. This regulation places more stringent demands on manufacturers, necessitating a comprehensive overhaul of their operations. A primary focus is on compliance, with manufacturers required to meet rigorous regulatory requirements. This includes the submission of robust clinical data, exhaustive performance evaluations and the implementation of rigorous quality management systems.

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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