European Guidance on Unique Device Identification (UDI) for medical devices expected in March 2018

On 12 February 2018 a workshop on Unique Device Identification (UDI) organised by the European Commission discussed the principles of UDI for medical devices. European regulators are currently implementing the UDI system with guidance expected to be published under the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) in March 2018. It is anticipated that most markets will have a UDI system within five years and the codes will be linked to different databases for each market.

The UDI system is for positive identification of medical devices, up to the level of batch or serial number but it does not replace requirements regarding device name, name and address of the manufacturer, warnings, etc. It is expected that UDI will develop into a global standard and become a central part of medical device CE Marking.

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Published on 15. February 2018 in News EU