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Spotlight on the EU Medical Device Regulations
January 9, 2013
The European Commission’s proposed medical device regulations call for implementing a unique device identifier (UDI) system within the next 10 years, but provide few clues as to what that system will look like or what it will cost devicemakers. How the system will link up with the Eudamed database and be utilized by regulators to track devices and root out counterfeits is also largely unknown. Given the lack of detail in the legislation, industry experts are hoping the commission will work with the U.S. Food and Drug Administration (FDA) and International Medical Device Regulators Forum (IMDRF) to create an interoperable system that eases the cost and burden of adopting UDI.
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