MHRA Updates Guidance on Borderline Products

October 25, 2019

The UK’s Medicines and Healthcare products Regulatory Agency updated its guidance on when “borderline” products are medicines and when they are medical devices. 

The update includes a list of 25 products for which the agency sent “urgent notices” from 2016 to 2019 because companies claimed the product was in one category while some versions were regulated as the other category. 

The agency clarified the status of the products and explained why they were either a drug or a device.

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