1. Introduction



There are currently over 500.000 types of Medical Devices and in vitro diagnostic devices (IVDs) on the EU market [1]. Their variety is only limited by the ingenuity of science. According to the European Patent Office, Medical Devices comprise the most active technological area in terms of the volume of patents filed: https://www.epo.org/about-us.html

In general terms, any apparatus, instrument, appliance, software, implant, reagent, material or other article intended by the manufacturers to be used in human beings for specific purposes can be qualified as a Medical Device. The field of Medical Devices is highly diverse, which makes it difficult to define and classify them, and, consequently, develop and implement an adequate legal regulatory framework to ensure their safe and efficacious use.