Medical devices - ISS (EN)

Medical devices (DM) are an indispensable tool 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 (EU Regulation 2017/745).

The Italian National Institute of Health (ISS), as part of its activities, 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, DM software, cyber security). The ISS also supports market surveillance and post-marketing surveillance of the products, in accordance with the current regulation.