Preparing For The European Medical Device Regulation

The European Medical Device Regulation (EU MDR) is set to have a profound impact on medical device manufacturers operating within the European Union (EU). This regulation came into effect in May 2021, featuring transition periods that vary according to device classification.

EU MDR has introduced substantial challenges for the medical device industry. According to a November 2022 report by Politico, these new rules have unintentionally triggered a public health emergency by creating a looming shortage of available devices.

The effects of EU MDR are felt by both companies and patients, with some medical devices already taken off the market, awaiting certification. For medical device manufacturers, it's crucial to be informed. Access the full article below to get answers to some of the industry's most pressing questions about the regulation.