Practical arrangements for the railway vehicle authorisation process

Scope

Establishes the practical arrangements for the vehicle type authorisation and vehicle placing-on-the-market authorisation process under Directive (EU) 2016/797, covering pre-engagement, application content, and the assessment roles of ERA and national safety authorities through the one-stop shop. Core procedural reference for manufacturers, applicants, and authorising entities in EU vehicle authorisation projects. In force as amended by Implementing Regulation (EU) 2020/781.

Implementing Regulation (EU) 2018/545 sets out the practical arrangements for the vehicle type authorisation and vehicle placing-on-the-market authorisation process established by Directive (EU) 2016/797, structuring the procedure into a pre-engagement phase, application submission, and assessment by the European Union Agency for Railways and the national safety authorities of the intended area of use. It defines the content an application file must contain, including EC declarations of verification, technical documentation, and evidence addressing any open points or specific cases, and specifies the statutory timescales within which the assessing authorities must respond. The Regulation formalises the 'one-stop shop' IT system through which applicants, ERA and national safety authorities exchange all authorisation-related documentation and communication. It also governs authorisations for vehicles already in service seeking an extended area of use and the renewal or amendment of existing authorisations. As amended by Implementing Regulation (EU) 2020/781, it remains the core procedural reference used by manufacturers, keepers and authorising authorities in every EU vehicle authorisation project.