{
  "url": "https://openlegislation.uk/eu-regulation-2018-545/annex-I/division-18",
  "json_url": "https://openlegislation.uk/eu-regulation-2018-545/annex-I/division-18.json",
  "legislation": "eur/2018/545",
  "legislation_title": "Commission Implementing Regulation (EU) 2018/545 of 4 April 2018 establishing practical arrangements for the railway vehicle authorisation and railway vehicle type authorisation process pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2018-545",
  "path": "annex/I/division/18",
  "kind": "division",
  "number": "18",
  "heading": "Annexes (M):",
  "text": "The information that shall be included in the application is specified per authorisation case. An (x) in the column for the applicable authorisation case indicates that the information is mandatory (M) for this authorisation case.\nNon standardised methodology\nFirst authorisation\nRenewed type authorisation\nExtended area of use\nNew authorisation\nAuthorisation in conformity to type\n18.1\nThe supporting evidence for the requirements capture in accordance with Article 13(1).\nIf the applicant uses the methodology set out in Annex I of Regulation (EU) No 402/2013, the supporting evidence consists of the declaration by the proposer referred to in Article 16 of Regulation (EU) No 402/2013 and the safety assessment report referred to in Article 15 of Regulation (EU) No 402/2013.\nIf another methodology is used, the evidence required is that necessary to demonstrate that it provides the same level of assurance as the methodology set out in Annex I of Regulation (EU) No 402/2013.\nX\nX\nX\n18.2\nMapping table indicating where the information needed for the aspects to be assessed according to Annex II and III can be found\nX\nX\nX\nX\n18.3\nThe relevant decisions for non-application of TSIs according to Article 7 of Directive (EU) 2016/797 (when applicable)\nX\nX\nX\nX\nX\n18.4\nDeclaration of conformity to the type and associated documentation (Article 24 Directive (EU) 2016/797)\nX\n18.5\nEC Declarations of Verification for the mobile subsystems, including accompanying technical files (Article 15 Directive (EU) 2016/797).\nX\nX\nX\nX\n18.6\nThe file accompanying the application and the decision from the previous authorisation or when applicable the reference to the decision issued according to Article 46 and to the full accompanying file for the decision archived in the one-stop shop.\nX\nX\nX\n18.7\nSpecification of and where applicable a description of the methodology used for the requirements capture for the:\n(a) essential requirements for subsystems as specified in Article 3 and Annex III of Directive (EU) 2016/797;\n(b) technical compatibility of the subsystems within the vehicle;\n(c) safe integration of the subsystems within the vehicle; and\n(d) technical compatibility of the vehicle with the network in the area of use.\nX\nX\nX\n18.8\nCSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the requirements capture for the essential requirements ‘safety’ for the subsystems and safe integration between subsystems.\nX\nX\nX\n18.9\nWhen not fully covered by TSIs and/or national rules, the documentary evidence of the technical compatibility of the vehicle with the network in the area of use.\nX\nX\nX\n18.10\nRisk declaration (Article 16 Regulation (EU) No 402/2013) covering the requirements capture for the essential requirements ‘safety’ for the subsystems and safe integration between subsystems for aspects not covered by the TSIs and the national rules.\nX\nX\nX\n18.11\nCSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the potential modification of the overall safety level for the vehicle\nX\nX\n18.12\nRisk declaration (Article 16 Regulation (EU) No 402/2013) covering the potential modification of the overall safety level for the vehicle\nX\nX\n18.13\nInformation required for ERATV (according to Annex II of Decision 2011/665/EU)\nX\nX\nX\n18.14\nMaintenance & operation documentation (including rescue), when not included in 18.4 and/or 18.5.\nX\nX\nX",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Non standardised methodology"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2018/545/annex/I/division/18",
    "retrieved_at": "2026-11-01T14:44:12.295569+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}