1.For managing safety-critical components, the entity in charge of maintenance shall take into account the initial identification of safety-critical components by the manufacturer of the vehicle together with any specific maintenance instructions recorded in the technical files of subsystems referred to in Article 15(4) of Directive (EU) 2016/797.
2.The entity in charge of maintenance shall, either directly or via the keeper provide information to the railway undertakings and infrastructure managers operating the vehicles, keepers, manufacturers, holders of vehicles authorisations and holders of the type authorisation of vehicles, subsystems or components, as most appropriate and shall in particular, inform them of exceptional maintenance findings beyond wear and tear.
3.Where during the maintenance of a vehicle an entity in charge of maintenance becomes aware of evidence suggesting a component not previously identified as safety critical should be considered as such, it shall inform the manufacturer, the holder of the vehicle type authorisation and the holder of the vehicle authorisation without delay.
4.To confirm if the component is safety critical the manufacturer, when it can be identified, shall perform a risk assessment. It shall take into account the component's intended use and the environment in which it is intended to be used. As appropriate, the entity in charge of maintenance shall adjust its maintenance procedures to ensure monitoring and the safe maintenance of the component.
5.Safety critical components including those identified under paragraph 4 above, shall be recorded in and managed through the relevant vehicle documentation as follows:
(a)manufacturers shall manage information on safety critical components and appropriate maintenance instructions related to them through reference in the technical file of subsystems referred to in Article 15(4) of Directive (EU) 2016/797; and
(b)entities in charge of maintenance shall manage safety critical components and appropriate maintenance instructions as well as relevant maintenance activities in the maintenance file or documentation referred to in Article 14 of Directive (EU) 2016/798.
6.The entity in charge of maintenance shall inform the rail sector and the rail supply industry about new or unexpected safety relevant findings including exceptional maintenance findings beyond wear and tear, in relation to vehicles, subsystems or other components, when the related risks are relevant for more actors and are likely to be poorly controlled. The entity in charge of maintenance shall use the Safety Alert IT or another informatics tool provided by the Agency for this purpose.
7.At the request of the entity in charge of maintenance or of the keeper of the vehicle, the manufacturers shall provide technical and engineering support for safety-critical components and their safe integration.