A medical device is an instrument, apparatus, appliance, software, implant, reagent, or other article intended by the manufacturer to be used for human beings for diagnostic or therapeutic purposes, and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means. The range extends from simple products such as adhesive bandages to highly complex systems such as pacemakers or artificial joints.
The regulatory requirements for medical devices differ from those for pharmaceuticals. In Europe, they are subject to the Medical Device Regulation (MDR, EU 2017/745). The path to market launch (CE marking) requires a clinical evaluation, which often includes clinical investigations according to the ISO 14155 standard to demonstrate the safety and performance of the product. CROs such as Mediconomics offer specialized services to support medical device manufacturers in these clinical investigations and in the conformity assessment process.