Abstract

The regulatory system for the safety of medical devices marketed in the European Union is based on an articulated mechanism of ex ante compliance obligations and monitoring duties, and ex post remedies that come into play when the citizens’ health is put at risk. The Medical Devices Regulation (Regulation 2017/745) reinforces the previous regime of the Medical Devices Directives (Directives 90/385/EEC and 93/42/EEC) through the introduction of more stringent pre-authorization requirements for high-risk medical devices and improvements in post-market surveillance. However, significant deficiencies in the accountability schemes still jeopardise the protection of patients harmed by medical devices. This paper aims to shed light on those weak points of the EU legislation on medical devices that threaten the effectiveness of the ex post remedial apparatus