If your medical device has been cleared for distribution in the EU. The CE Mark is mandatory. It must be affixed to the device, or the device's identification plate, or its packaging. Theoretically, your device may be stopped at customs upon entry to the EU if the CE Mark is not present on the packaging. So good business practice tells you its a very good idea.
If you already possess a stock of packaging without a CE mark on it, try overlabeling the packaging until your stock and be updated and replaced. It's inexpensive and may save you a lot of grief!
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james_tillman_rac 3/28/2008
If your medical device has been cleared for distribution in the EU. The CE Mark is mandatory. It must be affixed to the device, or the device's identification plate, or its packaging. Theoretically, your device may be stopped at customs upon entry to the EU if the CE Mark is not present on the packaging. So good business practice tells you its a very good idea.
If you already possess a stock of packaging without a CE mark on it, try overlabeling the packaging until your stock and be updated and replaced. It's inexpensive and may save you a lot of grief!