Greetings!
I would like to know if the CE Mark and no MRI symbol MUST be on the actual component - a wearable insulin patch, Class II device or can it be on the labeling components: user guide, etc?. Also, I would like to know the specific guidance, ASTM standard and regulation that states it must be on the device and discusses the requirements in general.
Thanks for the guidance!
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Wendy Hills
Senior Regulatory Affairs Specialist
Johnson & Johnson Diabetes Solutions Companies
Chesterbrook PA
United States
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