Regulation (EU) 2017/745 on medical devices (MDR) is fully applicable since May 26, 2021. The MDR is considered a game changer for the medical device industry. The bad news is,… Read More
Did you know that the European Commission has issued Regulation (EU) 2019/1020? This regulation on market surveillance and compliance of products lays out updated requirements on the appointment of EU… Read More
Don’t worry about changing your EU Authorized Representative! The process became much more formal, but not complicated. We guide you through. Change process under the MDR / IVDR Under the… Read More
