reg 44ZH Initial reporting of serious incidents
(1) The manufacturer must report to the Secretary of State any serious incident involving the manufacturer’s device. (2) The report must include— (a) the manufacturer’s name and contact details; (b) the UK responsible person’s name and contact details (if there is one); (c) details of the initial reporter of the serious incident; (d) a description of the device, including its current location and any unique device identifiers; (e) a description of the serious incident; (f) the manufacturer’s preliminary conclusions in relation to the cause of the serious incident; (g) consideration of whether any field safety corrective action is required to prevent or reduce the risk of a further serious incident; (h) details of any preventive or corrective action taken by the manufacturer. (3) The manufacturer must submit the report— (a) immediately after the manufacturer has established the causal (or reasonably possible causal) relationship between the device and the serious incident, and (b) unless paragraph (4) or (5) applies, no later than 15 days after the manufacturer becomes aware of the serious incident. (4) If the serious incident being reported involves a serious public health threat, the report must be submitted no later than 2 days after the manufacturer becomes aware of the threat. (5) If there is a death or an unanticipated serious deterioration in a person’s state of health, the report must be submitted no later than 10 days after the manufacturer becomes aware of the incident. (6) If the same device model or a variant of that model is involved in similar serious incidents and the manufacturer has either— (a) identified the cause, or (b) implemented a field safety corrective action, the manufacturer and the Secretary of State may agree that the manufacturer can submit periodic summary reports instead of individual serious incident reports.