In accordance with the FDA guideline “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking” for class I Medical Devices and Unclassified devices, deadlines have been drawn in order to adapt to the UDI requirements.
As regard the class I Medical Devices and the Unclassified devices manufactured and labelled following September 24, 2018, from September 24, 2020, it is necessary to adapt to the requirements related to the format of the date suggested by FDA (21CFR 801.18), to the UDI labelling (21 CFR 801.20 end 50) and to the dispatch of data to the Global Unique Device Identification (GUDID) (21CFR 830.300) database. The requirements related to the affix of the UDI Direct Marking, namely the marking directly on the device (21 CFR 801.45), will be implemented from September 24, 2022.
As regard the class I Medical Devices and the Unclassified devices manufactured and labelled before September 24, 2018, it is necessary to adapt to the requirements related to the format of the date suggested by FDA (21CFR 801.18) to the UDI labelling and to the dispatch of data to the GUIDID database.
The requirements related to the affixing of the UDI permanent marking will be activated from September 24, 2020.
According to 21 CFR 801.45 FDA will not apply the UDI marking requirements as regard the non-sterile class I Medical Devices and the Unclassified devices, manufactured and labelled before September 24, 2022, if the unique identifier of the device (UDI) would be derived from other information labelled directly onto the device.
It is useful to remember that the UDI system is an identification code placed onto the labelling of a medical device and it is intended for the adequate identification of the product. Particularly, this system allows to rapidly identify a device by facilitating with greater accuracy the indication of possible associated adverse events.
Thema carries out preparatory and support activities for the registration of a medical device in the USA.
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