The new European regulation EU 2017/745 on Medical Devices, (MDR) will come into full application on 26th May 2020 and replaces the current Directive 93/42/EEC. It introduces, among others, totally new requirements concerning the registration and traceability of medical devices put on the market via an identification system based on a Unique Device Identifier (UDI).
This publication applies to the medical devices put on the market by the gas manufacturers according to the new medical device regulation EU 2017/745 and concerns the implementation of the requirements related to the UDI system. This publication has been prepared to enable EIGA members to understand the overall UDI system and to efficiently implement these new requirements for the medical devices they are putting on the market as the legal manufacturer in compliance with the regulatory timeframe. It addresses the production of the UDI, the associated labelling and the registration of the medical devices in the UDI - EUDAMED database with a focus on the specificities of medical device gases and medical pipeline systems.