MDCG 2022-7: UDI System Q&A
A Q&A document on the EU Regulation’s Unique Device Identification (UDI) system has been published to answer some of the most burning questions when it comes to the application of UDI to medical devices and IVDs. The document covers the following themes: UDI-DI. Basic UDI-DI (BUDI). UDI Labelling. UDI Rules for System and Procedure Packs ...
Unique Device Identification (UDI) System EU2017/745 & EU2017/746
The EU’s medical device regulations 2017/745 and 2017/746 require that each device placed on the market must be accompanied by a unique device identification (UDI) which shall be used for identification and traceability purposes. Note, this requirement applies to all devices apart from custom-made and investigational devices. The above is the proposed symbol to be ...
UDI Issuing Entities
In early June, the European Commission (EC) announced the four issuing entities for the Unique Device Identifier (UDI): GS1, the Health Industry Business Communications Council (HIBCC), ICCBA Informationsstelle für Arzneispezialitäten (IFA GmbH). The decision was made with the help of the Medical Device Coordination Group (MDCG) after the four companies were found to meet all ...
