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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.
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, for example: websites, GUDID, EUDAMED, marketing materials.
Published information regarding the identification, use, specifications, manufacture or limitations of a medical device.
Did you know? The word information appears 362 times in the regulation, more than any other word including risk.
Ensure you do not mislead the user or the patient about the device’s intended purpose, safety and performance by:
You need to provide instructions for use (IFU) along with your device. The IFU should include:
On your label you will need to indicate: