http://www.legislation.gov.uk/eur/2018/545/article/39Commission 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)Commission Implementing Regulation (EU) 2018/545Commission 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)2020-12-12King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02018R0545-20200616texttext/xmlen2020-06-16CHAPTER 6PROCESSING THE APPLICATION
Article 39The assessment of the application by the authorising entity1.

The authorising entity shall assess the aspects specified in Annex II.

2.

Where a vehicle type authorisation and/or vehicle authorisation for placing on the market is to be issued for an area of use that is limited to the networks within one Member State and where the applicant has requested for the NSA to be the authorising entity in accordance with Article 21(8) of Directive (EU) 2016/797, the authorising entity shall, in addition to the assessments specified in paragraph 1, assess the aspects referred to in Annex III. In that case the authorising entity shall, in addition to those aspects listed in Annex III, also check whether there is any relevant information recorded pursuant to Article 8(2) and shall take it into account for the assessment of the application. Any issues raised shall be recorded in the issues log as specified in Article 41.

3.

When a non-standardised methodology for the requirements capture has been used by the applicant, the authorising entity shall assess the methodology applying the criteria laid down in Annex II.

4.

The authorising entity shall check the completeness, relevance and consistency of the evidence from the applied methodology for requirements capture irrespective of the method used. For a new authorisation as specified in Article 14(1)(d) the assessment performed by the authorising entity shall be limited to the parts of the vehicle that are changed and their impacts on the unchanged parts of the vehicle. The checks to be performed by the authorising entity for an ‘extended area of use’ authorisation as specified in Article 14(1)(c) shall be limited to the applicable national rules and to the technical compatibility between the vehicle and the network for the extended area of use. Checks already carried out at the previous authorisation shall not be repeated by the authorising entity.

5.

An assessment file shall be issued by the authorising entity and shall contain the following:

(a)

clear statement on whether the result of the assessment is negative or positive as per the applicant's request for the concerned area of use and, where appropriate, conditions for use or restrictions;

(b)

summary of the assessments performed;

(c)

report from the issues log for the concerned area of use;

(d)

filled-in checklist giving evidence that all aspects specified in Annex II, and when applicable Annex III, have been assessed.