Europe – COVID-19 tests: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19

A medical device is a device intended by its manufacturer for a medical purpose, such as treatment of disease, alleviation of a handicap or investigation of a physiological process. A cardiac stent, an X-ray machine or a leg prosthesis are medical devices. They are regulated at EU level by two pieces of legislation: Directive 90/385/EEC on active implantable medical devices (e.g. pacemakers) and Directive 93/42/EEC on other medical devices (e.g. the cardiac stents or X-ray machines). The Directives are to be replaced by Regulation (EU) 2017/745 as of 26 May 2021…