Unique Device Identification (UDI)
Requirements, deadlines, secure labeling
The implementation of the UDI Directive is mandated for medical device manufacturers.
This is not only true for companies that sell their products on the American market, since
UDI is also being implemented in the EU and other countries. Medical products must be
clearly identified to ensure safe traceability and patient safety. In addition to the marking
of packaging and labels, this also applies to the direct marking of high risk products such as
implants and instruments. Manufacturers must maintain deadlines and requirements to
implement marking systems to apply marking in accordance with UDI requirements and
medical standards. In order to implement the demanding labeling, serialization and
marking requirements, appropriate technologies are required that allow the codes to be
applied and checked with high resolution, permanence with exceptional quality and, if
necessary, even in the smallest of spaces.