MedTech Europe guidance for assigning Basic UDI-DI v1.1

This guidance document aims to provide a framework for companies to help assign Basic Unique Device Identification and Device Identifier (UDI-DI) to medical devices. This document describes the legal and other rules that must be understood before making decisions on the Basic UDI-DI grouping within the European Union. The Basic UDI-DI is the main access key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics. The Basic UDI-DI is independent of the packaging and labelling of the device. It does not appear on any trade item.

Main sections:

- Basic UDI-DI legal requirements

- Basic UDI-DI decision tree

- Explanation for the Basic UDI-DI decision tree

- General rules to comply with

- Rules specific for systems or procedure packs

- General assumptions