La responsabilità solidale del "mandatario" nell'ambito della disciplina europea sui dispositivi medici

The recent Regulations on medical devices and in vitro diagnostic medical devices issued in 2017 and not yet in force, lay down a very complex system of rules concerning the placing on the market, making available on the market and putting into service of safe and non-dangerous medical devices. The Regulations provides for joint and several liabilities for damages caused by the defects of the devices which is shared between different economic operators, first of all the manufacturer but also the so-called “authorised representative”. However, the boundaries of these liabilities and their link with the Directive 85/374/CEE, especially as enacted by the single Member States, are not so clear, which may leave some doubts about who are the defendants in a legal action for damages.