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Risks posed by medical devices have necessitated a comprehensive monitoring system whereby all serious product incidents will be reported (315). The medical devices vigilance system applies to all incidents (316) which directly or indirectly might have led to, the death or a temporary or permanent serious deterioration of a patient’s, user, or other person’s state of health or a serious public health threat, and which resulted from:

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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.