F1ANNEXES
F1ANNEX XIIIPROCEDURE FOR CUSTOM-MADE DEVICES
F11.For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following information:
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F12.
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F13.
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F14.The statement referred to in the introductory part of Section 1 shall be kept for a period of at least 10 years after the device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.
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F15.
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