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LIVE EVENT

IVD classification under the IVDR

The In-Vitro Diagnostic Regulation 2017/746 has changed the classification of IVDs, replacing the list-based approach of Directive 98/79/EC with an approach based on rules and risks. MDCG 2020-16 Guidance on Classification Rules for IVD Medical Devices under Regulation (EU) 2017/746 provides detailed explanation of the IVDR classification rules and examples for each rule.

This webinar reviews the classification rules and gives an overview of the MDCG guidance document. It also discusses how the intended purpose of a device impacts on its classification and the link with NB codes and help manufacturers prepare for the transition to the IVDR.

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Date and time: Thursday, 20 May 2021, 5.30 pm (CEST)

Your speakers: Marta Carnielli, IVD Technical Officer

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