The EU MDR Labeling Journey:

The European Union's regulatory landscape underwent a significant shift when the Medical Devices Regulation (EU) 2017/745 (EU MDR) officially went into effect on May 26, 20171. Under these most recent guidelines, new medical devices must start conforming to EU MDR on May 26, 2021, and all devices must conform by May 26, 20242. Since the European Union's (EU) medical device market is dominated by the
United States, which supplies two-thirds of its medical devices and contributes 41% of all medical device patents3, ensuring compliance in time to meet the May 26, 2021 deadline is critical to maintaining market access for medical device companies.