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Reporting of defects and adverse effects

Health Products (Medical Devices) Regulations 2010

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—(1) For the purposes of section 42(1) of the Act, every manufacturer, importer, supplier or registrant of a medical device, whether registered or unregistered, shall, upon becoming aware of any defect in the medical device or any adverse effect that has arisen from the use thereof, inform the Authority of the defect or adverse effect within the following time delimited after the manufacturer, importer, supplier or registrant first becomes aware of the defect or adverse effect:(a)within 48 hours, if the information relates to any defect or adverse effect that represents a serious threat to public health;(b)within 10 days, if the information relates to an incident that has led to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person; and(c)within 30 days, if the information relates to an incident a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person.(2) For the purposes of paragraph (1)(a), a defect in, or an adverse effect that has arisen from the use of, a medical device, represents a serious threat to public health if —(a)it is a hazard arising from a systematic failure of the medical device that the manufacturer, importer, wholesaler or registrant of the medical device has become aware of;(b)it may lead to the death of, or a serious injury to, any person;(c)the existence or probable rate of occurrence of, or degree of severity of the harm caused by, the hazard was not previously known or anticipated by the manufacturer or product owner of the medical device; and(d)it is necessary for the manufacturer or product owner of the medical device to take prompt action (including the recall of the medical device) to eliminate, or reduce the risk of, the hazard.

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