This article compares and contrasts the regulation of medicinal products and medical devices in the UK and in Europe. While there are many similarities in the control between the two sectors there are marked differences. These differences arise partly from the different nature of the products and the industries, but also from the different type of control. Medical devices are controlled through the ‘New Approach’ Directives. Both regulatory systems are currently undergoing European Reviews. The borderline between medicinal products and devices is considered in this article noting that in many areas the distinction is becoming increasingly complex.