Since September 2014 an Unique Device Identifier (UDI) is obligatory for Class III medical devices, that are sold in the US. As from September 2016 FDA will make this Identifier obligatory also for Class II medical devices and from 2018 for Class I medical devices.

It’s not that difficult but you must be aware of the following aspects. You need a unique identification number for each version of your medical device. This identification must be on your product. Your product information must be uploaded in the FDA – GUDID database. Your company has to be registered.

For more information:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm

The European Union is also investigating the possibilities of UDI.
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32013H0172&from=EN

Its recommended to contact your producer in advance.

Of course Unitron will fulfill the necessary actions for her customers on simple request!

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