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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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Each conformity assessment body shall be responsible for compiling the documents and producing all necessary reports related to its conformity assessments performed pursuant to Article 26.
1.The applicant shall, as applicable per authorisation case, perform the necessary checks in order to establish the evidence referred to in Annex I.
2.The authorising entity and the concerned NSAs for the area of use shall not prescribe the requirements for the evidence to be included in the technical files accompanying the EC declarations of verification of the subsystems, but where there is a justified doubt, they may request the applicant to carry out additional verifications.
1.The correction of non-conformities with TSIs and/or national rules requirements shall be carried out by the applicant, unless a non-application of TSI in accordance with Article 7 of Directive (EU) 2016/797 has been granted. That may apply mutatis mutandis for national rules when allowed by the Member State's national legal framework.
2.In order to mitigate a situation of non-conformity the applicant may, alternatively, do one or more of the following:
(a)change the design; in which case the process shall begin anew from the requirements capture set out in Article 13, for the modified elements only and those elements affected by the change;
(b)establish conditions for use of the vehicle and other restrictions in accordance with Article 20; in which case the conditions for use of the vehicle and other restrictions shall be defined by the applicant and checked by the relevant conformity assessment body.
3.The applicant's proposal for conditions for use of the vehicle and other restrictions as pursuant to Article 20 to correct a non-conformity shall be based on the necessary conformity assessments pursuant to Article 25.
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