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Back	FOBA White Paper - UDI Requirements, Deadlines, Secure Labeling according to FDA and MDR The implementation of the UDI Directive is mandated for medical device manufacturers. This has been in effect since 2014 for companies selling their products on the American market, and will be as of 2020 also in the EU and other countries. Medical products must be clearly identified to ensure reliable traceability and patient safety. In addition to the marking of packaging and labels, this also applies to the direct marking of high risk devices such as implants and instruments. Manufacturers must maintain deadlines and need to implement marking systems that are able to mark in accordance with UDI requirements and medical standards. In order to fulfill the demanding labeling, serialization and marking requirements, appropriate technologies must allow for the application of high resolution codes with long-term durability, even in the smallest of spaces, while additionally providing a verification process to read back code contents and quality
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