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Commission Implementing Regulation (EU) 2018/545Show full 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)
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- Revised 16/06/20200.51 MB
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18. Annexes (M):
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.
| a Non standardised methodology | ||||||
| First authorisation | Renewed type authorisation | Extended area of use | New authorisation | Authorisation in conformity to type | ||
|---|---|---|---|---|---|---|
| 18.1 | The supporting evidence for the requirements capture in accordance with Article 13(1). If 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. If 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. | X | X | X | ||
| 18.2 | Mapping table indicating where the information needed for the aspects to be assessed according to Annex II and III can be found | X | X | X | X | |
| 18.3 | The relevant decisions for non-application of TSIs according to Article 7 of Directive (EU) 2016/797 (when applicable) | X | X | X | X | X |
| 18.4 | Declaration of conformity to the type and associated documentation (Article 24 Directive (EU) 2016/797) | X | ||||
| 18.5 | EC Declarations of Verification for the mobile subsystems, including accompanying technical files (Article 15 Directive (EU) 2016/797). | X | X | X | X | |
| 18.6 | The 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. | X | X | X | ||
| 18.7 | Specification of and where applicablea a description of the methodology used for the requirements capture for the: (a) essential requirements for subsystems as specified in Article 3 and Annex III of Directive (EU) 2016/797; (b) technical compatibility of the subsystems within the vehicle; (c) safe integration of the subsystems within the vehicle; and (d) technical compatibility of the vehicle with the network in the area of use. | X | X | X | ||
| 18.8 | CSM 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. | X | X | X | ||
| 18.9 | When 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. | X | X | X | ||
| 18.10 | Risk 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. | X | X | X | ||
| 18.11 | CSM 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 | X | X | |||
| 18.12 | Risk declaration (Article 16 Regulation (EU) No 402/2013) covering the potential modification of the overall safety level for the vehicle | X | X | |||
| 18.13 | Information required for ERATV (according to Annex II of Decision 2011/665/EU) | X | X | X | ||
| 18.14 | Maintenance & operation documentation (including rescue), when not included in 18.4 and/or 18.5. | X | X | X | ||
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