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Regulatory and Compliance

EU MDR: The Challenge of Compliance by May 2020

Medical device manufacturers are less mature in their labeling management compared to peers in other regulated industries, because until now regulatory measures around traceability and reporting have been less pronounced. But with EU Medical Device Regulations (MDR) due to go live in just a few months, how will device manufacturers cope with the numerous implications for patient-facing content? Kallik’s Graham Francis measures the gap companies must close.