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(1)An obligation imposed by a medical devices provision is to be treated as a duty owed to any person who may be affected by a breach of the obligation.
(2)Accordingly, a breach of such an obligation gives rise to a right of action for breach of statutory duty.
(3)Subsections (1) and (2) are subject to—
(a)a provision to the contrary in a medical devices provision, and
(b)the defences and other incidents applying to actions for breach of statutory duty.
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