EU Medical Device Regulation (MDR) labelling compliance

摘要

PRISYM ID's Mark Cusworth examines the EU Medical Device Regulation and its implications for labelling — and looks ahead to a future that could become a nightmare unless companies act now. Imagine waking up in a world in which the product registrations of all your medical devices have become invalid. It's a world in which you need to reregister every device that you plan to ship to Europe. And, worse still, it's a world wherein that reregistration process dictates changes to the labelling content of all those devices — from the product artwork to the literature that accompanies it.