Commission Implementing Regulation (EU) 2018/545Show full title

CHAPTER 1 GENERAL PROVISIONS

Article 1 Subject matter and scope

1. 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.

2. This Regulation shall apply without prejudice to Article 21(16) and (17) of Directive (EU) 2016/797.

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, except 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, in which case the relevant date is 16 June 2020.

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

1. The authorising entity shall issue vehicle type authorisations and/or vehicle authorisations for placing on the market (‘the authorisations’) in accordance with Articles 21, 24 and 25 of Directive (EU) 2016/797 and with the provisions of this Regulation.

2. 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.

3. In case the Agency is the authorising entity, it shall coordinate the activities of the NSAs for the area of use related to vehicle type authorisation and/or vehicle authorisation for placing on the market.

4. The authorising entity shall provide pre-engagement at the request of the applicant.

5. The authorising entity shall carry out its tasks in an open, non-discriminatory, transparent way and shall exercise professional judgment, be impartial and proportionate, and provide documented reasons for any decision.

6. The authorising entity shall establish internal arrangements or procedures for managing the issuing of a vehicle type authorisation and/or a vehicle authorisation for placing on the market. Those arrangements or procedures shall take into account the agreements referred to in Article 21(14) of Directive (EU) 2016/797 and where relevant, multilateral agreements as referred to in Article 21(15) of Directive (EU) 2016/797.

7. Where the applicant indicates under Article 5(2) that the validity of the type authorisation has been affected the authorising entity shall update the ERATV accordingly.

8. 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

1. The holder of the vehicle type authorisation shall be responsible for the configuration management of the vehicle type and the accompanying file for the decision issued in accordance with Article 46.

2. Without prejudice of Articles 53 and 54, the holder of the vehicle type authorisation, as part of the configuration management of the vehicle type, shall inform the authorising entity that issued the vehicle type authorisation about any changes in Union law that affect the validity of the type authorisation.

Article 6 Responsibilities of the infrastructure manager

1. 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.

2. 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

1. 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).

2. In undertaking its responsibilities, the NSAs for the area of use shall carry out its tasks in an open, non-discriminatory, transparent way and shall exercise professional judgment, be impartial, proportionate, and provide documented reasons for conclusions reached.

3. The concerned NSAs for the area of use shall provide pre-engagement at the request of the applicant.

4. 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.

5. The NSAs for the area of use shall establish internal arrangements or procedures for managing the issuing of a vehicle type authorisation and/or a vehicle authorisation for placing on the market. Those arrangements or procedures shall take into account the agreements referred to in Article 21(14) of Directive (EU) 2016/797 and where relevant, multilateral agreements as referred to in Article 21(15) of Directive (EU) 2016/797.

6. The NSAs for the area of use shall set up, publish and keep up to date guidelines describing their language policy, communication provisions and the process for temporary authorisation when required according to the national legal framework and make them available to the public free of charge.

Article 8 Responsibilities of the Agency

1. The Agency shall set up, publish and keep up to date guidelines describing and explaining the requirements set out in this Regulation, and make them available to the public free of charge, in all the official languages of the Union. The guidelines shall also include model templates that may be used by the authorising entity and the NSAs for the area of use for the exchange and recording of information and model templates for the application that may be used by the applicant.

2. The Agency shall establish a protocol and procedures for the recording and exchange of information referred to in Article 7(4). Other affected or concerned parties may have access to relevant information, provided that the confidentiality of information is safeguarded.

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

1. 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).

2. Any decision concerning the issuing of the vehicle type authorisation and/or vehicle authorisation for placing on the market taken by the Agency, including the documented reasons for the decision and where applicable, the issued vehicle type authorisation and/or vehicle authorisation for placing on the market shall be provided in the language referred to in point (a) of paragraph 1.

Article 11 Vehicle authorisation process for tram-trains in the Single European Railway Area

1. For the purpose of a tram-train vehicle type authorisation and/or a tram-train vehicle authorisation for placing on the market intended to be operated in the Union rail system, without prejudice to Article 1 of Directive (EU) 2016/797, and when no technical specification for interoperability (‘TSI’) applies to the concerned tram-train vehicle or tram-train vehicle type as described by the Article 1(5)(b) of Directive (EU) 2016/797, Member States may use a procedure provided for in its national legal framework regarding the tram-train vehicle type authorisation and/or tram-train vehicle authorisation for placing on the market. In such a case, the applicant shall refer to the national framework of the Member State concerned regarding the procedure to follow for the tram-train vehicle type authorisation and/or tram-train vehicle authorisation for placing on the market.

2. In case of a tram-train vehicle type authorisation and/or a tram-train vehicle authorisation for placing on the market intended to be operated in the Union rail system for cross-border operation, and when no TSI applies to the concerned tram-train vehicle type, the applicant shall apply to the authorising entities designated by the Member States involved, which shall cooperate with a view to issuing a tram-train vehicle type authorisation and/or a tram-train vehicle authorisation for placing on the market.

3. In other cases, a tram-train vehicle and tram-train vehicle type in the scope of Directive (EU) 2016/797 shall be authorised according to the procedure set out in this Regulation.

Article 12 Cross-border agreements

1. 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.

2. 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.