The manufacturer shall undertake to institute and keep updated a post-marketing surveillance system. This undertaking shall include the obligation on the part of the manufacturer to notify the competent authorities of the following events immediately on learning of them: (i) any change in the characteristics or performances and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or deterioration in his state of health; (ii) any technical or medical reason resulting in the withdrawal of a device from the market by a manufacturer.
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