reg 44ZI Investigation and final reporting of serious incidents
(1) After submitting a serious incident report under regulation 44ZH (initial reporting of serious incidents), the manufacturer must as soon as possible— (a) investigate the serious incident and the device or devices concerned, (b) review the required risk analysis for the device or devices concerned taking into account the serious incident and any proposed preventive and corrective actions, and (c) submit a final report to the Secretary of State setting out— (i) the methods and conclusions of the investigation; (ii) consideration of whether any field safety corrective action is required to prevent or reduce the risk of a further serious incident; (iii) details of any field safety corrective action the manufacturer has taken or intends to take; (iv) details of similar serious incidents involving the same device model or a variant of that model. (2) The Secretary of State may— (a) give advice to a manufacturer regarding the serious incident investigation; (b) initiate a separate investigation; (c) require the approved body (if there is one) to provide information and assessments relevant to the serious incident and field safety corrective action. (3) A manufacturer must— (a) cooperate with the Secretary of State in relation to the investigations referred to in paragraphs (1)(a) and (2)(b); (b) upon request, provide the Secretary of State with updates and documents relevant to an investigation referred to in paragraphs (1)(a) and (2)(b) and do so within 3 working days of the date of any such request; (c) not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the serious incident, before informing the Secretary of State of such action.