Francesca Nanni

How MDs are classified in America and Europe according to the risks they are subject to. In both America and Europe, medical devices are classified based on the level of risk they pose to patients and users. The classification criteria vary slightly between the two regions, but generally, the higher Read more…

Summary of the actual regulations valid in the European Union Medical Device Directive (MDD)  has been the body which regulates the marketing and safety of medical devices in Europe since the 1990s. In contrast to FDA, the EU classifies medical devices into four classes depending upon their risk level and Read more…