title: The drug-device interface.
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.
authors.affiliation: European Regulatory Affairs, Smith and Nephew, Group Research Centre, Yorkshire, UK.
authors.forename: I R
authors.initials: IR
authors.lastname: Cutler
mesh_terms: D016503:Drug Delivery Systems / Q000295:instrumentation / Q000592:standards*; D004869:Equipment Safety; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D007883:Legislation, Medical; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*