Framework
EUMDR — Registration and UDI
The EU MDR 2017/745 establishes a comprehensive registration and Unique Device Identification (UDI) system for medical devices in the European market. It mandates that manufacturers assign UDI codes to their devices, register in the European database on medical devices (EUDAMED), and maintain traceability from manufacturer through to the end user.
Overview
Background
Regulation (EU) 2017/745 introduced the UDI system and EUDAMED database to improve traceability and post-market surveillance of medical devices in the European Union. These provisions drew on the global UDI framework developed by the International Medical Device Regulators Forum (IMDRF) and replaced the fragmented registration systems that existed under the previous directives.
Applicability
These requirements apply to all manufacturers placing medical devices on the EU market. The UDI system applies to all devices except custom-made devices. Economic operators, including importers and distributors, also have registration and traceability obligations. Notified bodies and competent authorities interact with EUDAMED for regulatory oversight and market surveillance purposes.