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Paragraph 7 Requirements as to design and construction

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

The device shall be designed, manufactured and packed in a non—reusable packaging according to procedures which are sufficient to ensure that—

(a)

the device is sterile when placed on the market; and

(b)

if handled in accordance with conditions as to storage and transport laid down by the manufacturer, the device remains sterile until the packaging is removed and the device is implanted.