Medical Device Regulation in the EU
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Coding regulations for medical devices
To identify medical devices through their distribution and use, the U.S. Food and Drug Administration (FDA) has created and regulated the Unique Device Identification (UDI) system. When fully implemented in September 2020, most medical devices in the US will include a unique device identifier in human and machine-readable forms. Now the European Union is also pursuing this approach and obliging medical device manufacturers to label their products gradually from May 2021 onwards according to their risk class.
Find out the coding requirements for medical device manufacturers that derive from the U.S. UDI system and the European Medical Device Regulation.
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