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No Need For UDI On Some Drug/Device Combinations In The EU

 
• By Amanda Maxwell

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.  

The European Commission’s Medical Device Coordination Group (MDCG) has endorsed a guidance document on the application of UDI rules to the device element of drug/device combination products.

The document, MDCG 2019-2 Guidance, states that if a product is assessed and authorized in accordance with the Medical Device Regulation (MDR), the device part will be subject...

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