How Have the Regulations Changed Due to the Current Global Health Crisis and What Does This Mean for Medical Device Manufacturers in Europe? Background: Medical Device Regulation in the EU Unlike device regulation in the U.S., which is governed by the FDA, in Europe, medical devices are not regulated by the EMA. Rather, medical device [...]The post Medical Device Regulation in the EU in the Midst of the COVID-19 Pandemic appeared first on The Weinberg Group.