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. )

CHAPTER 1

GENERAL PROVISIONS

Article 1

Subject matter and scope

This Regulation lays down requirements to be complied with by:

(a) the applicant, when submitting, through the one-stop shop referred to in Article 12 of Regulation (EU) 2016/796 of the European Parliament and of the Council, an application for vehicle type authorisation and/or vehicle authorisation for placing on the market;

(b) the Agency and the NSAs, when processing an application for vehicle type authorisation and/or vehicle authorisation for placing on the market and in relation to pre-engagement;

(c) the authorising entity, when deciding on the issuing of vehicle type authorisations or vehicle authorisations for placing on the market.

(d) the infrastructure managers, when providing conditions for the carrying out of tests in their network(s) and providing information for the vehicle authorisation regarding the area of use.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘authorising entity’ means the entity that issues the vehicle type authorisation and/or vehicle authorisation for placing on the market;

(2) ‘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’).

(3) ‘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: (a) requirements from relevant Union law and national rules are met; (b) changes are controlled and documented either in the technical files or in the file accompanying the issued authorisation; (c) information and data is kept current and accurate; (d) relevant parties are informed of changes, as required;

(4) ‘date of receipt of the application’ means: (a) 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; (b) 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;

(5) ‘entity managing the change’ means the holder of the vehicle type authorisation, the keeper or the entity entrusted by them.

(6) ‘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;

(7) ‘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;

(8) ‘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: (a) the assessments specified in Article 21(5)(b) of Directive (EU) 2016/797; (b) the consultations requested in Article 21(8) of Directive (EU) 2016/797; (c) 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;

(9) ‘pre-engagement’ means a procedural stage preceding the submission of an application for authorisation performed upon request of the applicant;

(10) ‘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;

(11) ‘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;

(12) ‘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;

(13) ‘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;

(14) ‘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;

(15) ‘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;

(16) ‘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;

(17) ‘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.

Article 3

Responsibilities of the applicant

The applicant shall submit its application for vehicle type authorisation and/or vehicle authorisation for placing on the market in accordance with the provisions of this Regulation.

It is the responsibility of the applicant to ensure that the relevant requirements from applicable legislation are identified and met when submitting its application for vehicle type authorisation and/or vehicle authorisation for placing on the market.

Article 4

Responsibilities of the authorising entity

For the purposes of issuing or refusing an authorisation, the authorising entity shall:

(a) Coordinate the assignment of the tasks to the relevant parties and the setting up of coordination arrangements between them;

(b) Undertake an assessment of the application file to reach the reasonable assurance that the vehicle type and/or vehicle conforms to the applicable laws;

(c) Compile any supporting documentation, the results of all relevant assessments and the documented reasons for its decision to issue or refuse the authorisation, in accordance with this Regulation.

Where the applicant indicates in its application that the intended area of use of the vehicle(s) or the vehicle type includes stations in neighbouring Member States with similar network characteristics, when those stations are close to the border, the authorising entity shall:

(a) receive confirmation from the NSAs of the neighbouring Member States that the relevant notified national rules and the obligations pertaining to the relevant cross-border agreements are met, before issuing the vehicle type authorisation and/or vehicle authorisation; and

(b) specify in the issued authorisation that the vehicle type authorisation and/or vehicle authorisation is also valid to such stations without an extension of the area of use.

Article 5

Responsibilities of the holder of the vehicle type authorisation

Article 6

Responsibilities of the infrastructure manager

In the area of use, the infrastructure manager's responsibilities in the framework of vehicle type authorisation and/or vehicle authorisation for placing on the market, based on the information provided by the applicant according to Article 18, shall be limited to the identification and provision of the following:

(a) operational conditions to be applied for the use of the vehicle for tests on the network;

(b) necessary measures to be taken on the infrastructure side to ensure safe and reliable operation during the tests on the network;

(c) necessary measures in the infrastructure installations to perform the tests on the network.

The concerned infrastructure managers for the area of use shall:

(a) support the applicant for the conditions to use the vehicle for tests on the network;

(b) provide information on the infrastructure in a non-discriminatory way for using the vehicle for tests on the network;

(c) identify and provide conditions and measures to use the vehicle for tests on the network within the given time frame specified in Article 21(3) and 21(5) of Directive (EU) 2016/797 based on the information provided by the applicant;

(d) by agreement with the applicant, participate in the pre-engagement.

Article 7

Responsibilities of the NSAs for the area of use

For the purposes of issuing a vehicle type authorisation and/or a vehicle authorisation for placing on the market, the NSAs for the area of use shall be responsible

(a) for their part of the assessment in accordance with Article 40;

(b) for issuing an assessment file to the authorising entity pursuant to Article 40(6).

The NSAs for the area of use shall share with the Agency and all other NSAs all information resulting from return of experience related to technical and operational matters that may be relevant for the issuing of a vehicle type authorisation and/or vehicle authorisation for placing on the market such as:

(a) information received pursuant to Article 4(5)(b) of Directive (EU) 2016/798;

(b) non-compliance with essential requirements that may lead to amendment or revocation of an authorisation in accordance with Article 26 of Directive (EU) 2016/797;

(c) deficiencies in a TSI in accordance with Article 6 of Directive (EU) 2016/797.

Article 8

Responsibilities of the Agency

Article 9

Use of an authorised vehicle

After performing the checks referred to in Article 23 of Directive (EU) 2016/797, a railway undertaking or an infrastructure manager may use a vehicle in the area of use, according to the conditions for use of the vehicle and other restrictions specified in the vehicle type authorisation and/or the authorisation for placing on the market.

Article 10

Language

Where the vehicle type authorisation and/or vehicle authorisation for placing on the market is to be issued in accordance with the provisions of Article 21(5) to (7) of Directive (EU) 2016/797, the applicant shall:

(a) submit the application and the file accompanying the application in one of the official languages of the Union;

(b) translate parts of the file accompanying the application upon request, in accordance with point 2.6 of Annex IV to Directive (EU) 2016/797. In this case, the language to be used is determined by the NSA and indicated in the guidelines referred to in Article 7(6).

Article 11

Vehicle authorisation process for tram-trains in the Single European Railway Area

Article 12

Cross-border agreements

The NSAs shall make publicly available on their website the procedure to be followed regarding cross-border agreements for the authorisation to cover stations in the neighbouring Member States, pursuant to Article 21(8) of Directive (EU) 2016/797, in particular:

(a) any existing cross-border agreements between NSAs that may have to be used;

(b) the procedure to be followed where such cross-border arrangements do not exist.

For a cross–border agreement on the process to issue an authorisation to cover stations in the neighbouring Member States, pursuant to Article 21(8) of Directive (EU) 2016/797, the NSAs shall specify the procedure to be applied, and shall at least provide the following details:

(a) the procedural stages;

(b) the time frames;

(c) the technical and geographical scope;

(d) the roles and tasks of the parties involved; and

(e) the practical arrangements for the consultation with the relevant parties.

CHAPTER 2

PREPARATION OF THE APPLICATION

Article 13

Requirements capture

In accordance with the overall objective of managing and mitigating identified risks to an acceptable level, the applicant shall, before submitting an application, undertake a requirements capture process which shall ensure that all the necessary requirements covering the design of the vehicle for its life cycle have been:

(a) identified properly;

(b) assigned to functions or subsystems or are addressed through conditions for use or other restrictions; and

(c) implemented and validated.

The requirements capture performed by the applicant shall in particular cover the following requirements:

(a) essential requirements for subsystems referred to in Article 3 and specified in Annex III to 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.

Article 14

Identification of the relevant authorisation

The applicant shall identify and choose the relevant authorisation from the following cases:

(a) first authorisation: the vehicle type authorisation and/or the vehicle authorisation for placing on the market issued by the authorising entity for a new vehicle type, including its variants and/or versions if any, and, where applicable, the first vehicle of a type, pursuant to Article 21(1) of Directive (EU) 2016/797;

(b) renewed vehicle type authorisation: the renewal of a vehicle type authorisation pursuant to Article 24(3) of Directive (EU) 2016/797 which does not require a change in design of the vehicle type;

(c) extended area of use: the vehicle type authorisation and/or the vehicle authorisation for placing on the market issued by the relevant authorising entity for an already authorised vehicle type and/or vehicle in order to extend the area of use without a change of the design, pursuant to Article 21(13) of Directive (EU) 2016/797;

(d) new authorisation: the vehicle type authorisation and/or vehicle authorisation for placing on the market issued by the authorising entity after a change of an already authorised vehicle and/or vehicle type, pursuant to Articles 21(12) or 24(3) of Directive (EU) 2016/797;

(e) authorisation in conformity to type: the vehicle authorisation for placing on the market for a vehicle or a series of vehicles that conform to an already authorised and valid vehicle type on the basis of a declaration of conformity to that type, pursuant to Article 25(1) of Directive (EU) 2016/797. Where applicable, there shall be a clear identification of the vehicle type version and/or the vehicle type variant to which the vehicle or series of vehicles is conform.

In cases of vehicle type authorisations pursuant to cases (c) and (d), the applicant, if he is the holder of the existing vehicle type authorisation, shall decide whether the authorisation will result in the creation of:

(a) a new vehicle type; or

(b) a new vehicle type variant within the existing type on which it is based.

If the applicant is not the holder of the existing type the authorisation shall result in the creation of a new type in accordance with Article 15(4).

An applicant may combine:

(a) a request for new authorisation with a request for an authorisation for an extended area of use; or

(b) a request for a first authorisation with a request for authorisation in conformity to type.

The time frames set out in Article 34(1) and (2) shall apply to the combined application. Where appropriate, it may result in the issuing of several authorisation decisions by the authorising entity.

Article 15

Changes to an already authorised vehicle type

Any changes to an authorised vehicle type shall be analysed and categorised as only one of the following changes and shall be subject to an authorisation as provided below:

(a) a change that does not introduce a deviation from the technical files accompanying the EC declarations for verification for the subsystems. In this case there is no need for verification by a conformity assessment body, and the initial EC declarations of verification for the subsystems and the vehicle type authorisation remain valid and unchanged;

(b) a change that introduces a deviation from the technical files accompanying the EC declarations for verification for the subsystems which may require new checks and therefore require verification according to the applicable conformity assessment modules but which do not have any impact on the basic design characteristics of the vehicle type and do not require a new authorisation according to the criteria set out in Article 21(12) of Directive (EU) 2016/797;

(c) a change in the basic design characteristics of the vehicle type that does not require a new authorisation according to the criteria set out in Article 21(12) of Directive (EU) 2016/797;

(d) a change that requires a new authorisation according to the criteria set out in Article 21(12) of Directive (EU) 2016/797.

If the entity managing the change is not the holder of the vehicle type authorisation and the changes made to the existing vehicle type are categorised as (b), (c) or (d) of paragraph 1, the following shall apply:

(a) a new vehicle type shall be created;