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The drug-device interface
1European Regulatory Affairs, Smith and Nephew, Group Research Centre, Yorkshire, UK.
Abstract:
The difference between a drug and a device appears clear, but there are instances when the distinction between a product being a drug or a device is blurred. By making reference to the EC Directives for medicinal products and medical devices, this article seeks to clarify the definition of a medical device that incorporates or administers a drug.
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