reg 44ZK Field safety corrective actions outside Great Britain
(1) A manufacturer of a device placed on the market or put into service in Great Britain must report to the Secretary of State when taking any field safety corrective action (“ FSCA ”) outside Great Britain, if— (a) the FSCA relates to a device which is of the same model as the device that has been placed on the market or put into service in Great Britain, and (b) the manufacturer is not taking the same FSCA in Great Britain. (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) descriptions of the devices, including any unique device identifiers; (d) the number of devices placed on the market or put into service in Great Britain and the estimated number of users; (e) a description of the FSCA and the reason why the FSCA is required outside Great Britain; (f) the reason the same FSCA is not required in Great Britain.