The deadline for all Class I and unclassified medical devices to bear a UDI-code is Sep 24, 2022. Starting from this date, all medical devices, regardless of classification, which are intended to be reused and reprocessed must bear a direct mark unique device identifier.
Thus, the regulation will now also affect class I devices such as dental drills, surgical instruments among others.
In the course of 2022, the last exceptions to registering the markings via the GUDID database will also expire and enforcement of the corresponding directives will commence.
The general rules regarding the characteristics of the identifier remain the same as previously set for the other risk classes. PHOTON ENERGY has successfully set up processes to support the medical device manufacturers with the implementation of unique device identification in their manufacturing.
Find out under what special circumstances no identifier is needed on our article on UDI quality standards and requirements.
Further ressources:
UDI Compliance Policies and UDI Rule Compliance Dates (fda.gov, external website)
