Medical devices in Europe, all but drugs: time to radically change their regulation?

Abstract

Medical devices represent a vast category of products that fuel a growing turnover of thousands of small- and medium-sized companies in Europe. After many years of debate, a very analytical and complex new European medical device regulation (MDR) has been approved, but its application is still ongoing. The new European MDR classifies medical devices in four classes by potential risk of harms. The main purpose of this classification by risk is to address new medical devices to the assessment proc