Labeling serves to communicate safety and performance related information to users of medical devices and/or patients as well as to identify individual devices. Regulatory Authorities require and specify information that manufacturers are expected to incorporate on the labeling when the device is placed onto the market.
Labeling is a written, printed or graphic matter, affixed to a medical device or any of its containers or wrappers, or accompanying a medical device, related to identification, technical description, and use of the medical device, but excluding shipping.
This matter must be designed according the requirements of national and international standards that are applicable to your product, such as EN980
Arazy Group can advice you in the labeling process to fit all the legal requirements where you sell your products.
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