reg 44ZJ Field safety corrective actions and field safety notices
(1) Unless paragraph (4) applies, before taking any field safety corrective action (“ FSCA ”) in relation to a device, a manufacturer must— (a) produce a risk assessment of the proposed FSCA, and (b) submit to the Secretary of State— (i) an initial report on the proposed action, and (ii) the proposed field safety notice setting out the details in paragraph (6). (2) The initial 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) a description of the devices, including any unique device identifiers; (d) a description of the FSCA and its proposed implementation; (e) the reason why the FSCA is required and the justification for the manufacturer’s chosen FSCA, based on the conclusions of the risk assessment produced under paragraph (1)(a); (f) the number of devices placed on the market or put into service in Great Britain and the estimated number of users affected. (3) After submitting the initial report and proposed notice under paragraph (1), the manufacturer must implement the FSCA as soon as possible and monitor its progress. (4) A manufacturer may submit an initial report and a copy of the field safety notice after taking the FSCA if the manufacturer believes the FSCA needs to be taken urgently. (5) When taking an FSCA, the manufacturer must take all reasonable steps to ensure the field safety notice is sent to users of the device. (6) The field safety notice must— (a) identify the devices involved and include any unique device identifiers in a searchable format within the notice; (b) explain the reasons for the FSCA with reference to the risks to any person; (c) describe all actions to be taken by users in response. (7) After completing the FSCA, the manufacturer must submit a final report to the Secretary of State setting out the outcome of the action and including evidence to demonstrate its effectiveness. (8) The manufacturer must provide the Secretary of State with— (a) the risk assessment produced under paragraph (1)(a), and (b) updates and evidence of the progress of the FSCA; upon request and within 3 working days of any such request.