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

CHAPTER 2 PREPARATION OF THE APPLICATION

Article 13 Requirements capture

1. 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.

2. 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.

3. The risk management process set out in Annex I to Commission Implementing Regulation (EU) No 402/2013(1) shall be used by the applicant as the methodology for requirements capture as regards the essential requirements ‘safety’ related to the vehicle and subsystems as well as safe integration between subsystems for aspects not covered by the TSIs and the national rules.

Article 14 Identification of the relevant authorisation

1. 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.

2. 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).

3. 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

1. 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.

2. When a change falls under point (b) or (c) of paragraph 1, the technical files accompanying the EC declarations for verification for the subsystems shall be updated and the holder of the vehicle type authorisation shall keep available the relevant information upon request of the authorising entity and/or the NSAs for the area of use.

3. When a change falls under point (c) of paragraph 1 the holder of the vehicle type authorisation shall create a new vehicle type version or a new version of a vehicle type variant and provide the relevant information to the authorising entity. The authorising entity shall register in ERATV the new version of the vehicle type or the new version of the vehicle type variant in accordance with Article 50.

4. 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;

(b) the entity managing the change shall become the applicant; and

(c) the application for authorisation of the new vehicle type may be based on the existing vehicle type and the applicant may choose the authorisation case specified in Article 14(1)(d).

Article 16 Changes to an already authorised vehicle

1. Changes to an already authorised vehicle which are linked to substitution in the framework of maintenance and limited to replacement of components by other components fulfilling identical functions and performances in the framework of preventive or corrective maintenance of the vehicle do not require an authorisation for placing on the market.

2. Any other changes to a vehicle shall be analysed and categorised in accordance with Article 15(1).

3. The entity managing the change shall request a new authorisation for placing on the market in accordance with Article 14(1)(d) when a change falls under Article 15(1)(d).

4. If the entity managing changes categorised in accordance with Article 15(1)(b) and (c) to an already authorised vehicle is not the vehicle type authorisation holder it shall:

(a) assess the deviations from the technical files accompanying the EC declarations for verification for the subsystems;

(b) establish that none of the criteria set out in Article 21(12) of Directive (EU) 2016/797 are met;

(c) update the technical files accompanying the EC declarations for verification for the subsystems;

(d) notify the changes to the authorising entity.

This may apply to a vehicle or a number of identical vehicles.

The authorising entity may issue, within 4 months, a reasoned decision requesting an application for authorisation in case of a wrong categorisation or insufficiently substantiated information.

5. Every change to a vehicle shall be subject to configuration management under the responsibility of the keeper or of the entity entrusted by it.

Article 17 Identification of the rules including non-application of TSIs

1. Based on the choice of the authorisation case in accordance with Article 14 and the requirements capture set out in Article 13 the applicant shall identify all applicable rules, in particular the TSIs and national rules.

The applicant shall also consult and take into account the list of TSI deficiencies that is published on the Agency website.

In that case, the applicant shall identify the acceptable means of compliance issued by the Agency that is to be used in conjunction with the TSIs for the vehicle type authorisation and/or vehicle authorisation for the placing on the market process when establishing compliance with the TSIs.

2. The applicant shall identify any case which requires the non-application of TSIs and submit its application to the concerned Member States in accordance with the provisions of Article 7 of Directive (EU) 2016/797. When non-application of TSIs concerns vehicles with an area of use covering more than one Member State, the authorising entity and the concerned NSAs for the area of use of the vehicle have to coordinate with the applicant on the alternative measures to take in order to promote the final interoperability of the project.

3. When a new version of a TSI provides for transitional measures, the applicant may already select requirements from this new version of that TSI during the transitional period, if this new version explicitly allows it.

4. Where, pursuant to paragraph 3, requirements from a newer version of a TSI are selected the following shall apply:

(a) the applicant may select the requirements to be applied from different versions of a TSI and shall:

(i)

justify and document the consistency between the sets of requirements selected from different versions of a TSI to be applied;

(ii)

specify the partial selection of requirements from different versions of a TSI in the application for authorisation as required by Annex I;

(iii)

where there is a pre-engagement baseline and where relevant, the applicant shall request to the authorising entity an amendment or update of that pre-engagement baseline for the concerned TSI in accordance with the provisions in Article 24(4);

(b) the authorising entity when assessing the application shall check the completeness of the TSI requirements proposed by the applicant;

(c) the applicant shall not be required to submit a request for non-application of the TSI pursuant to Article 7 of Directive (EU) 2016/797 for those requirements.

5. Where this is provided for by the Member State legislation, the applicant may select requirements from different national rules in the same way as laid down in paragraph 3 for TSIs.

6. The applicant and the notified body or bodies may use the acceptable means of compliance referred to in Article 6(3) of Directive (EU) 2016/797 in the context of an EC verification of conformity, pending the adoption of the concerned TSIs.

7. The applicant and the designated body or bodies may use the acceptable national means of compliance referred to in Article 13(2) of Directive (EU) 2016/797 in the context of demonstrating compliance with national rules.

Article 18 Identification and definition of the necessary measures to use the vehicle for tests on the network

The applicant shall identify and define, on the basis of national rules for testing, the necessary measures to use the vehicle for tests on the network.

Article 19 Temporary authorisation to use the vehicle for tests on the network

1. Temporary authorisation to use the vehicle for tests on the network may only be issued by the NSA when it is required and specified in the national legal framework of the Member State.

2. NSAs assessing applications for temporary authorisation to use the vehicle for tests on the network shall do so in accordance with the relevant national legal framework.

Article 20 Identification of the intended conditions for use of the vehicle and other restrictions

The applicant shall identify the intended conditions for use of the vehicle and other restrictions linked to the vehicle type.

Article 21 Identification of the conformity assessments

The applicant shall identify the necessary conformity assessments pursuant to the provisions of Annex IV of Directive (EU) 2016/797.

(1)

Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 (OJ L 121, 3.5.2013, p. 8).