Medical devices (MD) are very important tools in clinical practice. The different types of devices, from the patch to the prosthetic heart valves to large radiological equipment, are grouped into different risk classes from the current regulatory framework (Regulation EU 2017/745).
The Istituto Superiore di Sanità (ISS, the National Institute of Health in Italy) implements experimental methodologies of biomechanical characterization and state of the art biocompatibility, in particular for high risk class medical devices (devices for cardiovascular and orthopedic applications, MD software, cyber security). The ISS also supports market surveillance and post-marketing surveillance of the products, in accordance with the current regulation.
