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UDIs for Medical Devices The European Landscape

Chan
Posted: 04/28/2016

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)

Interested in learning more about this topic?
Download the Agenda for UDIs & Traceability for Medical Devices Conference Here

The 2016 European UDIs & Traceability for Medical Devices Forum will bring together regulatory experts from public and regulatory bodies, healthcare organisations and device manufacturers to discuss how best to prepare and react to the European regulatory changes with regards to UDIs.



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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Chan
Posted: 04/28/2016