UDIs for Medical Devices The European Landscape


Chanice Henry
04/28/2016

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While the US advances with its coverage of medical device classes within the U.S. Food and Drug Administration (FDA) Unique Device Identification regime, other countries around the globe are progressing their own track and trace strategies for medical devices. Through the collaboration of the world’s regulatory agencies it is hoped that a synchronized approach to medical device identification will be achieved on an international level, amidst their efforts to tackle counterfeiting, increase accountability and enable safety corrective measures. (2)

In early 2013, the European Commission released a recommendation upon a proposed structure for the UDI requirements system in the EU. Now, the current trilogue negotiation between the three EU institutions – the European Parliament, Council and Commission, is expected to produce the adopted final regulatory text within 2016. Market analysts have forecasted that after this text is agreed and adopted, the industry is likely to be given three years until the regulation will come into force. (5)



As the industry awaits the finalized regulations from the EU, some have looked at the FDA and predicted that the EU is likely to mirror the preferences of the US body.

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