reg 44ZG Preventive and corrective actions
(1) If the manufacturer of a device— (a) identifies a risk that following evaluation is deemed to compromise the performance or safety of the device, or (b) otherwise has reason to believe that the device is not in conformity with the relevant essential requirements, they must take the necessary preventive or corrective action as soon as possible to reduce that risk and bring the device into conformity. (2) The manufacturer must notify the action to— (a) the UK responsible person (if there is one); (b) the approved body for the device (if there is one); (c) if the action is a field safety corrective action, the Secretary of State in accordance with regulation 44ZJ (field safety corrective action). (3) The approved body must review the notification to determine whether there is any impact on the certification it has issued for the device. (4) The manufacturer must monitor the action to identify if any further action is required to reduce the risk posed and bring the device into conformity.