ABSTRACT
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. As a general rule, a combination product is regulated either by the Medical Devices Directive 93/42/EEC (MDD)/Active Implantable Medical Devices 90/385/EC (AIMDD)/Medical Device Regulation EU 2017/745 (MDR) for the conformity assessment procedure relevant to medical devices or by the Medicinal Products Directive 2001/83/EC (MPD) for the marketing authorization procedure applicable to medicinal products. The medical device function is usually achieved by physical means including mechanical action, physical barrier, replacement of or support to organs or body.
