1. OVERVIEW

This White Paper is intended as a guide to support manufacturers of in vitro diagnostic medical devices in the correct application of Regulation (EU) 2017/746 (IVDR) and in the preparation and management of the technical documentation.

Through a practical, compliance-oriented approach, this document provides guidance on device qualification, risk classification, grouping into device families (Basic UDI-DI), and planning interactions with Notified Bodies. Particular emphasis is placed on the updated transitional deadlines introduced by Regulation (EU) 2024/1860, the preparation of the technical documentation, and the demonstration of performance. Finally, the White Paper includes a section containing five FAQs aimed at addressing the regulatory and operational questions most frequently encountered by manufacturers. […]

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