"Current Perspectives on Medical Devices and the Quest for Clinical Data to Support their Marketing Authorization: A Short Overview"

Abstract

The need to collect clinical data in the EU market authorization process of medical devices (MDs), commonly known as CE marking, arises from the requirement to demonstrate that a device meets the "Essential Requirements", namely that it is safe, that it performs as intended by the manufacturer, and that any risks are acceptable when weighed against the benefits of the device. These data may come from scientific literature or be the result of clinical studies, called Clinical Investigations (CIs) in the case of Medical Devices (MDs). The aim of this article is to describe methodology and role of CIs on MDs in EU. In particular, this paper centers on the change occurring in the role of CIs following the full application on May 26, 2021, of the Medical Devices Regulation (MDR) (EU) 2017/745 and the repeal of Directives 93/42EEC on MDs (MDD) and 90/385 EEC on the Active Implantable Medical Devices (AIMD).