The publication of European Regulations on Medical Devices (MDR 2017/745) and in vitro diagnostic Medical Devices (MDR 2017/746) responds to the need to reform the regulatory system of Medical Devices and IVDs compared to current directives (MDD 93/42 / EEC and subsequent modifications and additions and IVDD 98/79/EC).

The following motivations led to the legislative change, prompted by some critical events occurred when directives were in force: the need to standardize EU countries national regulatory systems; Notified Bodies insufficient control on companies; the need for greater post-market surveillance and better devices traceability. Added to this is the need to manage increasingly innovative devices, including those using hybrid technologies.