According to the European Medical Device Regulation (MDR), ‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices. In addition, the ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device’s intended purpose and proper use and of any precautions to be taken. MDR annex I, section 23 list the general requirements that you as a manufacturer must follow in the context of label and IFU.
AML Christensen ApS
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