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Taking the Stress out of the FDA’s UDI Labelling Regulations

With the application of the FDA’s final ruling on medical devices Unique Device Identification (UDI) system in September 2013 there are now new regulations in force which means that medical device manufacturers will be compelled to implement important labelling changes over the forthcoming years. This will involve investment in labelling and product marking accompanied by restructuring manufacturing practices and supporting IT systems. By 2018 all medical devices (Class I-III) will be required to bare identifying information which is compliant with the § 801.20 standard, and by 2020 all devices (even with previous exemptions) will be forced to comply. The higher classification devices (Class III & II) will be required to achieve this standard of new regulations much sooner, some coming into force by the end of 2014. DoraniX integrated printing solutions has the expertise and experience to supply a full printing and labelling facility in order to take the stress out of adapting to these identification changes.

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