ABSTRACT
The notified body and the manufacturer may choose the European Union competent authority with whom they consult. In Europe, there are two regulatory routes for drug-device combination products, either as medical devices incorporating ancillary medicinal substances or as medicinal products utilizing a delivery device. The Ethics Committee guidance document MEDDEV 2.1/3 is an extremely useful document which provides detailed information on the classification criteria between medical devices and medicinal products. Consultation with a notified body is required on the device aspects in a similar manner to consultation with a competent authority on the medicinal substance aspects of devices incorporating an ancillary medicinal substance. The decisions of the Medical Device Expert Group on Borderline and Classification are published in the Manual of Decisions available on the European Commission website. The principal mode of action is attributable to the device element and the medicinal substance has a lesser, secondary effect.
