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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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For the purposes of this Regulation, the following definitions shall apply:
‘authorising entity’ means the entity that issues the vehicle type authorisation and/or vehicle authorisation for placing on the market;
‘basic design characteristics’ means the parameters that are used to identify the vehicle type as specified in the issued vehicle type authorisation and recorded in the European Register of Authorised Vehicle Types (‘ERATV’).
‘configuration management’ means a systematic organisational, technical and administrative process put in place throughout the lifecycle of a vehicle and/or vehicle type to ensure that the consistency of the documentation and the traceability of the changes are established and maintained so that:
requirements from relevant Union law and national rules are met;
changes are controlled and documented either in the technical files or in the file accompanying the issued authorisation;
information and data is kept current and accurate;
relevant parties are informed of changes, as required;
‘date of receipt of the application’ means:
where the Agency acts as the authorising entity, the first working day common to the Agency and to the NSAs concerned with the intended area of use following the acknowledgement of receipt of the application;
where a NSA acts as the authorising entity, the first working day in the Member State concerned following the acknowledgement of receipt of the application;
‘entity managing the change’ means the holder of the vehicle type authorisation, the keeper or the entity entrusted by them.
‘holder of the vehicle type authorisation’ means the natural or legal person that has applied for and received the vehicle type authorisation, or its legal successor;
‘justified doubt’ means an issue classified as ‘type 4’ according to Article 41(1)(d), with a justification and supporting evidence, raised by the authorising entity and/or the NSAs for the area of use concerning the information provided by the applicant in its application;
‘national safety authority for the area of use’ or ‘NSA for the area of use’ means the national safety authority when it performs one or more of the following tasks:
the assessments specified in Article 21(5)(b) of Directive (EU) 2016/797;
the consultations requested in Article 21(8) of Directive (EU) 2016/797;
issues the temporary authorisations, when required, for using the vehicle for tests on the network and takes measures to ensure that the tests on the network can take place as specified in Article 21(3) of Directive (EU) 2016/797;
‘pre-engagement’ means a procedural stage preceding the submission of an application for authorisation performed upon request of the applicant;
‘pre-engagement baseline’ means the opinion of the authorising entity and of the concerned NSAs for the area of use on the pre-engagement file;
‘requirements capture’ means the process of identification, assignment, implementation and validation of requirements performed by the applicant in order to ensure that relevant Union and national requirements are complied with. Requirements capture may be integrated in the product development processes;
‘safe integration’ means the fulfilment of the essential requirement on safety as specified in Annex III of Directive (EU) 2016/797 when combining parts into its integral whole, such as a vehicle or a subsystem as well as between the vehicle and the network, with regards to the technical compatibility;
‘vehicle type variant’ means an option for the configuration of a vehicle type that is established during a first authorisation of the vehicle type in accordance with Article 24(1) or changes within an existing vehicle type during its life cycle that require a new authorisation of the vehicle type in accordance with Articles 24(1) and 21(12) of Directive (EU) 2016/797;
‘vehicle type version’ means an option for the configuration of a vehicle type or type variant or changes within an existing type or type variant during its life cycle, created to reflect changes to the basic design characteristics that do not require a new authorisation of the vehicle type in accordance with Articles 24(1) and 21(12) of Directive (EU) 2016/797;
‘vehicle authorisation for placing on the market’ means the decision issued by the authorising entity based on a reasonable assurance that the applicant and the entities involved in the design, manufacture, verification and validation of the vehicle have fulfilled their respective obligations and responsibilities in order to ensure conformity with essential requirements of the applicable legislation or to ensure conformity with the authorised type enabling that the vehicle may be placed on the market and may be used safely in the area of use according to the conditions for use and other restrictions, when applicable, specified in the vehicle authorisation and in the vehicle type authorisation;
‘vehicle type authorisation’ means the decision issued by the authorising entity based on reasonable assurance that the applicant and the entities involved in the design, manufacture, verification and validation of the vehicle type have fulfilled their obligations and responsibilities in order to ensure conformity with the essential requirements of the applicable legislation enabling that a vehicle manufactured according to this design may be placed on the market and may be used safely in the area of use of the vehicle type according to the conditions for use of the vehicle and other restrictions, when applicable, specified in the vehicle type authorisation and to be applied to all vehicle authorised in conformity to this type;
[F1‘ relevant date ’ means 16 June 2019 as regards those Member States that have not notified the Agency and the Commission in accordance with Article 57(2) of Directive (EU) 2016/797 that they have extended the transposition period of that Directive. It means 16 June 2020 as regards those Member States that have notified the Agency and the Commission in accordance with Article 57(2) of Directive (EU) 2016/797 that they have extended the transposition period of that Directive and that have not notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797. It means 31 October 2020 as regards those Member States that have notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797 that they have further extended the transposition period of that Directive.]
Textual Amendments
F1 Substituted by Commission Implementing Regulation (EU) 2020/781 of 12 June 2020 amending Implementing Regulation (EU) 2018/545 as regards the dates of application and certain transitional provisions following the extension of the transposition deadline of Directive (EU) 2016/797 of the European Parliament and of the Council (Text with EEA relevance).
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