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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1. INTRODUCTION

With the entry into application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), as of 26 May 2022, the European regulatory framework has undergone a profound revision, replacing Directive 98/79/EC (IVDD). The IVDR introduces a more stringent regulatory system based on risk, scientific
evidence, and control throughout the entire device life cycle. The new framework strengthens the requirements relating to conformity assessment, performance, clinical evidence, quality management system (QMS), and post-market surveillance, with the objective of ensuring a high level of safety and protection of public health. However, the implementation of the IVDR has highlighted operational challenges related to the capacity of Notified Bodies. For this reason, Regulation (EU) 2024/1860 has extended the transitional periods for legacy IVDs until 2027, 2028, and 2029. This White Paper analyses the criteria for device qualification and classification, the rules governing access to the extended transitional periods, and the operational requirements necessary to ensure the continued placing on the European market.