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Keeping Track of Traceability – Preparing for the EU Medical Device Regulation

Under the FDA (Food & Drug Administration) rule in the USA, manufacturers have been required to implement UDI (unique device identification) on all medical product packaging since September 2014. European manufacturers of medical devices will now face even tougher regulations to ensure their products are safe to use under new EUlaws that are scheduled to come into effect from May 26, 2020. With this legislation coming into effect, Volker Watzke from Domino explains that manufacturers now have a responsibility to invest in a coding solution that allows them to apply traceability codes onto products as well aspackaging.