No Need For UDI On Some Drug/Device Combinations In The EU
While UDI will be required on all products that come under the scope of the EU's medical device regulations, what is the situation for drug/device combinations? The answer is not simple, and depends on an often-tricky regulatory assessment.
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There has been a recent update related to how Unique Device Identification (UDI) will be applied to medical devices in the EU. It limits the number of characters that are used in a code and provides a check digit.
Requirements for Unique Device Identification (UDI) will ultimately apply to all medtech manufacturers selling products in Europe. The upcoming mandates are complex and technical both for those developing UDI standards and for industry. Medtech Insight looks at progress so far on an EU UDI system, and sheds light on developments, terminology and how the system links together.
Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.