Where there is no ERATV register for the unchanged vehicle type, and there is a need to apply for a new authorisation (therefore there is a need to create a new type), only the aspects related to the change and its interfaces with the unchanged parts (namely, the scope of the change) need to be filled-in in ERATV. However, the more ERATV data the applicant is able to communicate to the Authorising Entity, the better. The “exceptional” mode of ERATV (where it is not mandatory to introduce all technical data in ERATV) can be used for this purpose.
Where it is not possible to find documentary evidence of the issued authorisation and/ or the file accompanying the authorisation for vehicles authorised under previous regimes (in particular, before Directive 2008/57/EC), the authorising entity should consider that the vehicle has been authorised as long as this is reflected in the NVR registration.
There are two main aspects that the entity contemplating a change will need to take into account:
If the entity in charge of the modification requires an authorisation it will need to make an application through the one-stop shop which would cover only the changes made to the vehicle. If it does not require an authorisation, the entity managing the change will still need to make sure that the obligations set up in Regulation (EU) 2018/545 and in Directive (EU) 2016/797 are fulfilled (e.g. performing conformity assessments as needed, updating technical files accompanying the EC Declaration of Verification, updating the EC Declarations of Verification, informing the Authorising Entity about potential updates in ERATV following the creation of a version of a vehicle type, etc.).
In the event of a change to a vehicle type and where there is a new applicant that becomes the holder of the vehicle type authorisation for a new vehicle type based on an existing vehicle type:
In the event of a change to a vehicle type where a new applicant becomes the holder of the vehicle type authorisation for a new vehicle type that is based on an existing vehicle type:
The arrangements are intended to allow people other than the original holder of the vehicle type authorisation to make changes to vehicle types and/ or vehicles. If original documentation from a previous authorisation isn’t fully available the process can still be applied in this way.
Temporary authorisation to use the vehicle for tests on the network is only required where specified by the Member State’s legal framework. In such a case, the national legal framework should specify the process to be followed and the applicable rules.
Even where there is no requirement for temporary authorisation, the risks of operating a vehicle that is being used for tests have to be managed, which involves (in addition to a temporary authorisation where applicable):
The application is made through the One-stop shop. When the area of use is limited to one Member State the applicant chooses the authorising entity responsible for issuing the authorisation, to be either the Agency or the national safety authority for the Member State. In all cases where the authorisation is for a vehicle having an area of use covering more than one Member State the authorising entity is the Agency.
In the case of an authorisation in conformity to type, it is beneficial if the authorising entity is the same entity that issued the vehicle type authorisation.
Where the applicant has a choice of authorising entity and has made its selection, the applicant is not able to change its choice unless the initial application is terminated and the applicant triggers a new application to the other authorising entity. In such a case, the applicant has to restart the whole authorisation process from the beginning.
‘First authorisation’ applies to a new vehicle type – including variants and versions – and where applicable, to the first vehicle of a new vehicle type.
‘Renewed vehicle type authorisation’ is used when the design of a vehicle type has not changed but there is a change to the applicable rules that includes a requirement for renewal of the authorisation. The scope of the authorisation is limited to the changed rules.
‘Extended area of use’ is required where the design of the vehicle has not changed but the area of use is extended.
‘New authorisation’ applies when a change has been made to an already authorised vehicle and/or vehicle type that requires authorisation. The scope of the assessment is limited to the changes.
‘Authorisation in conformity to type’ is used for a vehicle or a series of vehicles that conform to an already authorised and valid vehicle type. The authorisation is given on the basis of a declaration of conformity to that type.
For authorisation the applicant demonstrates the compatibility of the vehicle with the networks of the area of use.
After authorisation, route compatibility is checked by evaluating vehicle data against the information from the Register of Infrastructure and/or the infrastructure manager. These are simple cross-checks. Some particularities of a network may require tests, but this should be seen as an exception
There are a number of issues here. To begin with, there is no direct link between the need or not for a new authorisation and the need to create a new type or a variant of an existing type. When the entity managing the change is the holder of the vehicle type authorisation, it can decide whether to create a new type or a variant of an existing type, this is an administrative decision. In both cases, the changed vehicle and/or vehicle type will need a new authorisation.
New types are generally need if a manufacturer creates from new a railway vehicle (namely, new design). They may decide to divide this new design into different models in which case they can either have different types of each model or have one type with a number of variants.
A new type may also be needed as a result of modifications, although again it may be possible to create a variant of an existing type to manage this.
Finally, a new type will be necessary in almost all cases where the entity managing a change is not the holder of the existing vehicle type authorisation. Only changes classified according to Article 15(1)(a) of Regulation (EU) 2018/545 will not require a new authorisation.
No, type authorisation only applies to vehicles. Mobile subsystems (rolling stock and control-command and signalling) are placed on the market without authorisation.
Even in the case of a vehicle which has not type associated to it (which is normally the case for vehicles authorised before Directive 2008/57/EC) and where no other changes are required in the vehicle and/or vehicle type in order to be compatible with the extended area of use, there is a need to apply for an authorisation for the extended area of use, pursuant to article 21(13) of Directive (EU) 2016/797.
The ‘area of use’ is a basic design characteristic, following Article 48(c) of Regulation 2018/545. Therefore, an extension of the area of use without changes in the design will require:
If there is a need to make changes in the design in order to make it compatible with the extended area of use (e.g. new Class B signalling system), the entity managing the change may need to apply for both a new authorisation (if the criteria or Article 21(12) of Directive (EU) 2016/797 are triggered) and an extension of the area of use. Only the elements of the design that are changed, their interfaces with the unmodified parts and the technical compatibility with the networks to which the area of use is to be extended should be checked.
Where the Agency is authorising entity it is required to consult the concerned national safety authority for the area of use, who checks aspects of the application applicable to the area of use that falls within its Member State.
NoBos have to apply surveillance and audits of manufacturing process according to the relevant modules defined in Commission decision 2010/713/EU. The NoBo issues certificates when satisfied that the manufacturing processes and quality management system ensure that the manufactured vehicles conform to the type.
Assessment of applications is a process check and not a detailed examination of technical matters already sighed off by someone else (e.g. conformity assessment bodies or assessment body in the meaning of the Common Safety Methods on risk evaluation and assessment). If it becomes apparent that because of delays in managing the process there will be issues around timing then ERA will utilise its contingency measures (e.g. increasing the size of the team). If the issues are beyond the control of ERA then there will be a discussion with the applicant about the best way to proceed.
If the application is for an area of use limited to one Member State and the national safety authority is the authorising entity then the provisions for language in the relevant national legal framework apply. The language policy should be indicated in the application guide produced by that national safety authority.
In other cases the application and the file accompanying the application may be submitted by the applicant in any one of the official languages of the Union. Nonetheless the Agency and the national safety authorities concerned with the area of use can request that the applicant translates parts of the file accompanying the application. In order to reduce the need for translation and to facilitate exchanges during the assessment it is recommended to use English or a commonly agreed language for the assessment of the application. When applicable the choice of language for the assessment should be made during pre-engagement.
The holder of the vehicle type authorisation is the person that has applied for and received the vehicle type authorisation, or its legal successor. They are responsible for the configuration management of the vehicle type.
The holder of the vehicle type authorisation is considered to be capable of managing changes to the type that do not require authorisation in accordance with the criteria set out in Article 21(12) of Directive (EU) 2016/797. Where changes are made to an authorised vehicle type that introduce a deviation from the technical files accompanying the EC declarations for verification for the subsystems, and those changes are made by someone who is not the holder of the vehicle type authorisation, then a new vehicle type shall be created and the entity managing the change shall become the applicant. If an authorisation is given that person becomes the holder of the type authorisation for the new vehicle type.
Similarly, where changes are made to an already authorised vehicle that introduce a deviation from the technical files accompanying the EC declarations for verification for the subsystems but do not require authorisation in accordance with the criteria set out in Article 21(12) of Directive (EU) 2016/797, and those changes are made by someone who is not the holder of the vehicle type authorisation, then the entity making the changes is required to notify the authorising entity of the changes that have been made. The holder of the vehicle type authorisation is not required to submit such notifications.
Authorisation applies to vehicles and to vehicle types. A vehicle authorisation for placing on the market will always result in a vehicle type authorisation granted at the same time. A vehicle type authorisation (i.e. the design) does not necessarily require that a vehicle conforming to that type is authorised, the decision lies with the applicant.
A new vehicle type and/or vehicle must always be authorised. Where changes are made to the vehicle type and/or the vehicle, be it a change to the applicable rules sufficient to require a renewed type authorisation, a change to the design (dependent on the scale of the change) or a change to the area of use, there is a need to apply for an authorisation.
If an already authorised vehicle type and/or vehicle is changed, the extent of the changes must be analysed. A new authorisation is required if:
An unchanged vehicle requires authorisation if there is a change to the area of use.
The applicant may use the one-stop shop to request a review of the decision within one month from the date of receipt. The request shall include a list of issues that have not been properly taken into consideration during the process. The review shall be concluded within two months of the date of receipt of the request.
If the review confirms a negative decision by the authorising entity, the applicant may appeal. For applications where the Agency is the authorising entity this appeal is brought before the Board of Appeal. For applications where a national safety authority is the authorising entity, the appeal is brought before the national appeal body in accordance with the national procedure.
Pre-engagement is an optional stage that comes before the submission of an application for authorisation, where the applicant submits details of its proposed application so that a baseline can be agreed at an early stage in the process of developing the application.
The benefits can include:
An authorisation can be suspended, revoked or amended as a safety measure. If a serious safety risk is identified by a national safety authority during supervision the authorisation can be suspended as a temporary measure. If the vehicle type (i.e. the design) is subsequently proven not to have met the essential requirements the authorisation can be revoked. Revocation is therefore an action to be taken to deal with defective design or manufacture of a vehicle type or vehicles of a vehicle type. It is not to be used in the case of failure to meet the essential requirements due to actions or inactions of the safety management system of the railway undertaking or entity in charge of maintenance (e.g. a safety management system that does not properly control maintenance leading to vehicles no longer meeting the essential requirements).
In the case of a revocation of a vehicle type authorisation, there is no automatic revocation of the vehicle authorisation for placing on the market for vehicles conforming to that type. However, the concerned vehicles should be withdrawn, meaning that they can no longer be used.
The legal text of the Implementing Regulation on vehicle authorisation defines the time limits applicable to processing applications. These are the maximum times, not target times, and the actual time required will be influenced by the complexity and quality of the application.
The authorising entity is required to carry out a completeness check of the application within one month. For authorisation in conformity to type the decision should also be taken within one month. For other authorisation cases a decision must be made no later than four months after acknowledging the file is complete.
This timescale may be extended if the assessment has to be suspended in order for the applicant to resolve a justified doubt. The timescale for a suspension is agreed with the applicant and is proportionate to the difficulty of providing the information requested to address the justified doubt.
An application that is fundamentally deficient can be rejected during the completeness check, which takes place within one month of the receipt of the application.
An application that has not been found to be fundamentally deficient during the completeness check is then assessed by the authorising entity and concerned national safety authorities for the area of use. Any serious concern on the content of the application file, such that it needs to be amended before the authorisation decision can be made, may result in the rejection of the application if the matter is not addressed by the applicant within the assessment timeframe.
The use of the one-stop shop does not prevent other means of contact, such as phone calls, video conferences, face to face meetings etc. This is to be agreed between the applicant and the authorities concerned with the area of use, in particular, during pre-engagement (which is voluntary for the applicant).
Firstly, remember the requirements capture is the applicant’s responsibility not the authorities so if they do not cover everything they need to that is their concern (as it is the case nowadays). Authorities will conduct a general check to ensure that the most important things you would expect to find are there, but will rely in the judgement of the assessment body (CSM RA), where available, and will not perform detailed technical checks.
The Group of Representative Bodies (GRB), which is a group of associations comprising the companies making up the railway operating community and the supply and manufacturing industry, publishes on its website an informative listing of the relevant Union law. It should be noted that this list is for information only, and no assurance is given as to its accuracy, completeness or sufficiency.
The assessment body will be involved:
The assessment body does neither perform the risk assessment required in Annex I of Regulation (EU) 402/2013 for risk assessment nor provide advice or solutions that could compromise its independence. The proposer is responsible for carrying out all the risk assessment and risk management activities specified in Regulation (EU) 402/2013.
The role of the assessment body is to:
If the decision has been already taken before the relevant date (be it the decision that there is no need for a new authorisation, be it the authorisation decision), the file is considered to be closed, and there is no need to handover the file to the new regime.
For those cases where the decision by the MS/NSA on whether there is a need for a new authorisation or not has not been taken before the relevant date, there is a need to fulfil the requirements of the Directive (EU) 2016/797 and the Regulation (EU) 2018/545. The applicant needs to assess whether there is a need or not for a new authorisation, and if need be, submit an application through OSS. The Authorising Entity shall manage this application through the OSS.
OSS is an IT tool to support the process of application, assessment of the application and delivery of the authorisation. It is not to be used for other purposes. If there is no need to apply for an authorisation, there is no need to use the OSS.