Coding regulations for medical devices

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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Medical Device Regulation in the EU

Unique Device Identification System in the USA