Framework
EUIVDR — Registration and UDI
The EU IVDR 2017/746 establishes a comprehensive registration and Unique Device Identification (UDI) system for in vitro diagnostic medical devices in the European market. It mandates that manufacturers assign UDI codes to their IVD devices, register in the European database on medical devices (EUDAMED), and maintain traceability throughout the supply chain.
Overview
Background
Regulation (EU) 2017/746 introduced the UDI system for IVD devices, aligned with the global UDI framework developed by the International Medical Device Regulators Forum (IMDRF). The regulation replaced the limited registration requirements of the IVD Directive with a comprehensive system that enables better traceability, post-market surveillance, and transparency for IVD devices.
Applicability
These requirements apply to all manufacturers placing IVD medical devices on the EU market. The UDI system applies to all IVD devices. Economic operators, including importers and distributors, also have registration and traceability obligations. The requirements support the functioning of EUDAMED as the central database for IVD device information in the EU.