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FDA UDI vs. EU MDR Regulations Consideration of the Regulations and Implications for EU Labelling

In the EU, the new EU MDR regulation came into force in May 2017 (2017/745) and will replace the current Medical Device Directive (MDD) for all medical devices distributed in the EU. Similar to the US UDI regulation, it will require a code for tracking and a mark on the device itself. Debi Schimpf at Navitas Life Sciences explores the current FDA UDI regulation for medical devices and compares it to the upcoming EU MDR/IVDR regulation that will come into effect on 26 May 2021.