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Document 02018R0545-20200616
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)Text with EEA relevance
Consolidated text: 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)Text with EEA relevance
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)Text with EEA relevance
02018R0545 — EN — 16.06.2020 — 001.001
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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 (OJ L 090 6.4.2018, p. 66) |
Amended by:
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COMMISSION IMPLEMENTING REGULATION (EU) 2020/781 of 12 June 2020 |
L 188 |
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15.6.2020 |
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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)
CHAPTER 1
GENERAL PROVISIONS
Article 1
Subject matter and scope
This Regulation lays down requirements to be complied with by:
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;
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;
the authorising entity, when deciding on the issuing of vehicle type authorisations or vehicle authorisations for placing on the market.
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:
‘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;
‘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:
Coordinate the assignment of the tasks to the relevant parties and the setting up of coordination arrangements between them;
Undertake an assessment of the application file to reach the reasonable assurance that the vehicle type and/or vehicle conforms to the applicable laws;
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:
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
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:
operational conditions to be applied for the use of the vehicle for tests on the network;
necessary measures to be taken on the infrastructure side to ensure safe and reliable operation during the tests on the network;
necessary measures in the infrastructure installations to perform the tests on the network.
The concerned infrastructure managers for the area of use shall:
support the applicant for the conditions to use the vehicle for tests on the network;
provide information on the infrastructure in a non-discriminatory way for using the vehicle for tests on the network;
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;
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
for their part of the assessment in accordance with Article 40;
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:
information received pursuant to Article 4(5)(b) of Directive (EU) 2016/798;
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;
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:
submit the application and the file accompanying the application in one of the official languages of the Union;
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:
any existing cross-border agreements between NSAs that may have to be used;
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:
the procedural stages;
the time frames;
the technical and geographical scope;
the roles and tasks of the parties involved; and
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:
identified properly;
assigned to functions or subsystems or are addressed through conditions for use or other restrictions; and
implemented and validated.
The requirements capture performed by the applicant shall in particular cover the following requirements:
essential requirements for subsystems referred to in Article 3 and specified in Annex III to Directive (EU) 2016/797;
technical compatibility of the subsystems within the vehicle;
safe integration of the subsystems within the vehicle; and
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:
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;
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;
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;
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;
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 new vehicle type; or
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 request for new authorisation with a request for an authorisation for an extended area of use; or
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 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;
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;
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;
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 new vehicle type shall be created;
the entity managing the change shall become the applicant; and
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
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:
assess the deviations from the technical files accompanying the EC declarations for verification for the subsystems;
establish that none of the criteria set out in Article 21(12) of Directive (EU) 2016/797 are met;
update the technical files accompanying the EC declarations for verification for the subsystems;
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.
Article 17
Identification of the rules including non-application of TSIs
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.
Where, pursuant to paragraph 3, requirements from a newer version of a TSI are selected the following shall apply:
the applicant may select the requirements to be applied from different versions of a TSI and shall:
justify and document the consistency between the sets of requirements selected from different versions of a TSI to be applied;
specify the partial selection of requirements from different versions of a TSI in the application for authorisation as required by Annex I;
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);
the authorising entity when assessing the application shall check the completeness of the TSI requirements proposed by the applicant;
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.
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
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.
CHAPTER 3
PRE-ENGAGEMENT
Article 22
Pre-engagement
The selection of authorising entity made by the applicant for the pre-engagement shall be binding until, either:
the concerned application for vehicle type authorisation and/or vehicle authorisation for placing in the market has been submitted by the applicant;
the time frame from the issuing of the opinion referred to in Article 24(2) to the applicant's submission of the application for vehicle type authorisation and/or vehicle authorisation for placing on the market as specified in paragraph 2 has expired; or
the applicant has requested to end the pre-engagement.
Article 23
Pre-engagement file
The pre-engagement file accompanying the pre-engagement application shall contain the following:
a description of the vehicle type and/or vehicle to be authorised, including where applicable the intended variants and/or versions, and a description of the tasks and activities to develop it;
the applicant's choice of the authorising entity and of the authorisation case or cases pursuant to Article 14;
a specification of the intended area of use;
a specification of the anticipated conditions for use of the vehicle and other restrictions identified pursuant to Article 20;
the applicant's planning for its part of the vehicle authorisation process, including the planning that covers tests on the network, when applicable;
an identification of the methodology for the process for the requirements capture in accordance with Article 13;
the list of the rules and requirements identified by the applicant as those that are to be applied in accordance with Article 17 to Article 18;
a list of the identified conformity assessments pursuant to Article 21, including the modules to be applied and the use of Intermediate Statements of Verification (‘ISV’), where applicable;
a description of the practical arrangements to use the vehicle for tests on the network, where applicable;
a list of the content of the documentation that the applicant anticipates to submit to the authorising entity and the concerned NSAs for the area of use for the vehicle type authorisation and/or vehicle authorisation for placing on the market;
a proposal concerning the language to be used for the vehicle authorisation process pursuant to Article 10;
a description of the applicant's organisation for its part of the vehicle authorisation process including but not limited to the applicant's contact information, contact persons information, requests for setting up coordination and meetings with the authorising entity and the concerned NSAs for the area of use.
Article 24
Pre-engagement baseline
In case of changes affecting the pre-engagement file which are relevant for the pre-engagement baseline, the applicant shall send an amended and updated pre-engagement application only considering the changes and the interfaces with the unchanged parts. This may occur in the following situations:
changes to the design or to the assessment methodology resulting from major safety issues;
changes in legal requirements invalidating the pre-engagement baseline; or
any changes voluntarily introduced by the applicant.
CHAPTER 4
CONFORMITY ASSESSMENT
Article 25
Conformity assessment
Each conformity assessment body shall be responsible for compiling the documents and producing all necessary reports related to its conformity assessments performed pursuant to Article 26.
Article 26
Perform verifications and establish evidence
Article 27
Correction of non-conformities
In order to mitigate a situation of non-conformity the applicant may, alternatively, do one or more of the following:
change the design; in which case the process shall begin anew from the requirements capture set out in Article 13, for the modified elements only and those elements affected by the change;
establish conditions for use of the vehicle and other restrictions in accordance with Article 20; in which case the conditions for use of the vehicle and other restrictions shall be defined by the applicant and checked by the relevant conformity assessment body.
CHAPTER 5
SUBMITTING THE APPLICATION
Article 28
Establishment of evidence for the application
The applicant for a vehicle type authorisation and/or a vehicle authorisation for placing on the market shall establish the evidence for the application by:
putting together the EC declarations of verification for the subsystems composing the vehicle and providing the evidence, in the technical file accompanying the EC declarations, of the conclusions of the conformity assessments done following the identification carried out pursuant to Article 21;
ensuring that interfaces between subsystems that are not defined in TSIs and/or national rules, are covered by the requirements capture referred to in Article 13 and meet the essential requirements set out in Article 3(1) of Directive (EU) 2016/797.
Article 29
The compilation of the file accompanying the application
Article 30
Application content and completeness
For the authorisation extended area of use referred to in Article 14(1)(c), the following points shall apply:
the documentation to be added to the original full accompanying file for the decision issued in accordance with Article 46 by the applicant shall be limited to aspects concerning the relevant national rules and the technical compatibility between the vehicle and the network for the extended area of use;
when the original vehicle type authorisation included non-applications of TSIs, the applicant shall add the relevant decisions for non-application of TSIs in accordance with Article 7 of Directive (EU) 2016/797 covering the extended area of use to the original full accompanying file for the decision issued in accordance with Article 46;
in case of vehicles and/or vehicle types authorised under Directive 2008/57/EC or before, the information to be added by the applicant to the original file for the aspects covered by point (a) shall also include the applicable national rules.
Article 31
The submission of the application for authorisation through the one-stop shop
CHAPTER 6
PROCESSING THE APPLICATION
Article 32
Application completeness check
The concerned NSAs for the area of use shall:
check that the area of use is correctly specified for its part;
raise any issues concerning the completeness of the information and documentation provided for the assessment of the applicable national rules as specified in Annex III.
The completeness check referred to in paragraph 1 and 2 shall constitute a verification by the authorising entity, and the concerned NSAs for the area of use that:
all the required information and documents referred to in Article 30 have been provided by the applicant in the application for vehicle type authorisation and/or vehicle authorisation for placing on the market;
the provided information and documentation provided is considered relevant to allow the authorising entity and the concerned NSAs for the area of use to perform their assessments in accordance with Article 38 to Article 40.
Article 33
Acknowledgement of application
Article 34
Time frame for the assessment of the application
Article 35
Communication during the assessment of the application
Article 36
Information management concerning the assessment of the application
The authorising entity and the concerned NSAs for the area of use shall register in the one-stop shop the outcomes of the stages of the vehicle authorisation process in which they are involved, each for their respective part of the assessment as applicable, including all the documents relating to the application concerning the following:
receipt;
handling;
assessment;
conclusions of the assessment of the application as specified in Article 45;
final decision to issue or not the vehicle type authorisation or the vehicle authorisation for placing on the market;
final documentation for the vehicle type authorisation and/or the vehicle authorisation for placing on the market in accordance to Article 47.
Article 37
Coordination between the authorising entity and the concerned NSAs for the area of use for the assessment of the application
Before the authorising entity takes its final decision and before the concerned NSAs for the area of use submit their assessment files, the authorising entity and relevant NSAs for the area of use shall:
discuss the outcome of their respective assessment; and
agree on conditions for use and other restrictions and/or exclusions of area of use to be included in the vehicle type authorisation and/or in the vehicle authorisation for placing on the market.
Article 38
Assessment of the application
The assessment of the application shall be carried out by the authorising entity and the concerned NSAs for the area of use to establish a reasonable assurance that the applicant and the actors supporting the applicant have fulfilled their obligations and responsibilities in the design, manufacture, verification and validation stages of the vehicle and/or vehicle type in order to ensure conformity with the essential requirements of the applicable legislation so that it may be placed on the market and may be used safely in the area of use of the vehicle type according to the conditions of use and other restrictions specified within the application.
Article 39
The assessment of the application by the authorising entity
An assessment file shall be issued by the authorising entity and shall contain the following:
clear statement on whether the result of the assessment is negative or positive as per the applicant's request for the concerned area of use and, where appropriate, conditions for use or restrictions;
summary of the assessments performed;
report from the issues log for the concerned area of use;
filled-in checklist giving evidence that all aspects specified in Annex II, and when applicable Annex III, have been assessed.
Article 40
The assessment of the application by the concerned NSAs for the area of use
An assessment file shall be issued by the NSAs for the area of use and shall contain the following:
a clear statement on whether the result of the assessment is negative or positive as per the applicant's request for the concerned area of use and where appropriate conditions of use and restrictions;
a summary of the assessments performed;
a report based on the issues log for the concerned area of use;
a filled-in checklist giving evidence that all aspects listed in Annex III have been assessed.
Article 41
Categorisation of issues
The authorising entity and, when applicable the concerned NSAs for the area of use, shall record issues identified during the course of their assessment of the application file in an issues log and categorise them as follows:
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(a) |
‘type 1’ : issue that requires a response from the applicant for the understanding of the application file; |
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(b) |
‘type 2’ : issue that may lead to an amendment of the application file or minor action from the applicant; the action to be taken shall be left to the judgement of the applicant and shall not prevent the issuing of the vehicle type authorisation and/or the vehicle authorisation for placing on the market; |
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(c) |
‘type 3’ : issue that requires an amendment to the application file by the applicant but does not prevent the issuing of the vehicle type authorisation and/or vehicle authorisation for placing on the market with additional and/or more restrictive conditions for use of the vehicle and other restrictions as compared to those specified by the applicant in its application, but the issue must be addressed in order to issue the vehicle type authorisation and/or vehicle authorisation for placing on the market; any action to be performed by the applicant to resolve the issue shall be proposed by the applicant and shall be agreed with the party that identified the issue; |
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(d) |
‘type 4’ : issue that requires an amendment of the application file by the applicant; the vehicle type authorisation and/or vehicle authorisation for placing on the market shall not be delivered unless the issue is resolved; any action to be performed by the applicant to resolve the issue shall be proposed by the applicant and shall be agreed with the party that identified the issue. Type 4 issue shall include in particular non-compliance pursuant to Article 26(2) of Directive (EU) 2016/797. |
Following the response or the action taken by applicant according to the issue, the authorising entity or the concerned NSAs for the area of use shall re-evaluate the issues it identified, re-classify where relevant and assign one of the following status for each of the issues identified:
‘issue pending’ when the evidence provided by the applicant is not satisfactory and additional information is still required;
‘issue closed out’ when a suitable response has been provided by the applicant and no residual matter of concern remains.
Article 42
Justified doubt
Where there is a justified doubt, the authorising entity and/or the concerned NSAs for the area of use may, alternatively, do one or more of the following:
perform a more thorough and detailed check of the information provided in the application;
request supplementary information from the applicant;
request that the applicant conducts tests on the network.
The authorising entity and the concerned NSAs for the area of use shall, without prejudice to the provisions of Article 35, use the issues log referred to in Article 41 to manage any justified doubts. A justified doubt shall always:
be classified as a type 4 issue pursuant to Article 41(1)(d);
be accompanied by a justification; and
include a clear description of the matter that needs to be answered by the applicant.
Article 43
The checks to be performed by the authorising entity concerning the assessments performed by the concerned NSAs for the area of use
Where the result from the check referred to in paragraph 1 demonstrates that the assessments of the NSAs for the area of use are consistent, the authorising entity shall verify that:
the checklists referred to in Article 40(6)(d) have been filled-in completely;
all relevant issues have been closed.
Where the result from the check in paragraph 1 demonstrates that the assessments are not consistent, the authorising entity shall request the concerned NSAs for the area of use to further investigate the reasons. As a result of this investigation, alternatively, one or both of the following shall apply:
the authorising entity may review its assessment as referred to in Article 39;
the concerned NSAs for the area of use may review its assessment.
Article 44
Arbitration under Article 21(7) of Directive (EU) 2016/797 and Article 12(4)(b) of Regulation (EU) 2016/796
Where the Agency acts as the authorising entity, it may suspend the authorisation process, in consultation with the concerned NSAs for the area of use, during the cooperation needed to reach a mutually acceptable assessment and where applicable, until the Board of Appeal takes a decision, within the time frames set out in Article 21(7) of Directive (EU) 2016/797. The Agency shall give the applicant reasons for the suspension.
Article 45
Conclusion of the assessment of the application
The authorising entity shall ensure that the process for the assessment of the application has been carried out correctly by checking in an independent manner that:
the different stages of the process for the assessment of the application have been correctly applied;
there is sufficient evidence to show that all relevant aspects of the application have been assessed;
written responses to type 3 and 4 issues and requests for supplementary information have been received from the applicant;
type 3 and 4 issues were all resolved or where not resolved, together with clearly documented reasons;
the assessments and decisions taken are documented, fair and consistent;
the conclusions reached are based on the assessment files and reflect the assessment as a whole.
Article 46
Decision for the authorisation or the refusal of the application
The authorising entity shall state the following in its decision:
any conditions for use of the vehicle and other restrictions;
the reasons for the decision;
the possibility and means of appealing the decision and the relevant time limits.
The authorisation decision shall not contain any time limited conditions for use of the vehicle and other restrictions, unless the following conditions are fulfilled:
it is required because the conformity to the TSIs and/or national rules cannot be completely proven before the issuing of the authorisation; and/or
the TSIs and/or national rules require that the applicant produces a plausible estimate of compliance.
The authorisation may then include a condition that real use demonstrates performance in line with the estimate within a specified period of time.
CHAPTER 7
FINAL DOCUMENTATION
Article 47
Final documentation for the vehicle type authorisation and/or vehicle authorisation for placing on the market
Article 48
The information in the issued vehicle type authorisation
The vehicle type authorisation issued by the authorising entity shall contain the following information:
the legal basis empowering the authorising entity to issue the vehicle type authorisation;
identification of:
the authorising entity;
the application;
authorisation case as specified in Article 14;
the applicant for the vehicle type authorisation;
the EIN associated to the vehicle type authorisation;
an identification of the basic design characteristics of the vehicle type:
stated in the type and/or design examination certificates;
the area of use of the vehicle;
the conditions for use of the vehicle and other restrictions;
the reference, pursuant to the provisions of Article 16 of Regulation (EU) No 402/2013, including the document identification and the version, to the written declaration by the proposer referred to in Article 3(11) of Regulation (EU) No 402/2013, covering the vehicle type;
an identification of:
the vehicle type ID, in accordance with Annex II to Commission Implementing Decision 2011/665/EU ( 2 );
the vehicle type variants, where applicable;
the vehicle type versions, where applicable;
values of the parameters set out in the TSIs and, where applicable, in the national rules, for checking the technical compatibility between the vehicle and the area of use;
the vehicle type's compliance with the relevant TSIs and sets of national rules, relating to the parameters referred to in paragraph 1(d)(iv);
reference to the EC declarations of verification for the subsystems;
reference to other Union or national law with which the vehicle type is compliant;
reference to the documented reasons for the decision referred to in Article 45(5);
date and place of the decision to issue the vehicle type authorisation;
signatory of the decision to issue the vehicle type authorisation; and
the possibility and means of appealing the decision and the relevant time limits, including information about the national appeal process.
Article 49
The information in the issued vehicle authorisation for placing on the market
The vehicle authorisation for placing on the market issued by the authorising entity shall contain the following information:
the legal basis empowering the authorising entity to issue the vehicle authorisation for placing on the market;
identification of the:
authorising entity;
application;
authorisation case as specified in Article 14;
applicant for the vehicle authorisation for placing on the market;
EIN associated to the vehicle authorisation for placing on the market;
the reference to the vehicle type registration in ERATV, including the information on the vehicle type variant and/or vehicle type version, when applicable;
identification of the:
vehicles;
areas of use;
conditions for use of the vehicle and other restrictions;
reference to the EC declarations of verification for the subsystems;
reference to other Union or national law with which the vehicle is compliant;
reference to the documented reasons for the decision referred to in Article 45(5);
in case of an authorisation in conformity to type pursuant to Article 14(1)(e), the reference to the declaration of conformity with an authorised vehicle type, including information on the vehicle type version and/or vehicle type variant when applicable;
the date and place of the decision to issue the vehicle authorisation for placing on the market;
the signatory of the decision to issue the vehicle authorisation for placing on the market; and
the possibility and means of appealing the decision and the relevant time limits, including information on the national appeal process.
Article 50
Registration in ERATV and ERADIS
Pending the registration of the new version of a vehicle type or the new version of a vehicle type variant, the vehicles modified to be conforming to the new version may already be operated without delay.
Article 51
Review under Article 21(11) of Directive (EU) 2016/797
Article 52
Archiving of a decision and the full accompanying file for the decision issued in accordance with Article 46
CHAPTER 8
SUSPENSION OR REVOCATION OR AMENDMENT OF AN ISSUED AUTHORISATION
Article 53
Suspension, revocation or amendment of an issued authorisation
Article 54
The effect of suspension or revocation or amendment of an issued authorisation on the registration in ERATV, ERADIS and vehicle registers
CHAPTER 9
FINAL PROVISIONS
Article 55
Transitional provisions
In the case referred to in Article 21(8) of Directive (EU) 2016/797, the applicant shall decide whether to continue to be assessed by the NSA or to submit an application to the Agency. The applicant shall inform both of them and the following shall apply:
in cases where the applicant has decided to submit an application to the Agency, the NSA shall transfer the application file and the results of its assessment to the Agency. The Agency shall accept the assessment carried out by the NSA;
in cases where the applicant has decided to continue with the NSA, the NSA shall finalise the assessment of the application and decide on the issue of the vehicle type authorisation and/or vehicle authorisation for placing on the market in accordance with Article 21 of Directive (EU) 2016/797 and this Regulation.
Where a NSA recognises that it will not be able to issue a vehicle type authorisation and/or vehicle authorisation before 30 October 2020, it shall inform the applicant and the Agency immediately and paragraphs 2 to 4 shall apply.
A vehicle authorisation and/or vehicle type authorisation issued by the Agency between 16 June 2019 and 16 June 2020 shall exclude the network or networks in any of the Member States that have notified the Agency and the Commission in accordance with Article 57(2) of Directive (EU) 2016/797 and that have not yet transposed that Directive and not brought into force its national transposition measures. The NSAs of the Member States that have made such a notification shall:
treat a vehicle type authorisation issued by the Agency as equivalent to the authorisation for types of vehicles issued in accordance with Article 26 of Directive 2008/57/EC and apply paragraph 3 of Article 26 of Directive 2008/57/EC as regards this vehicle type;
accept a vehicle authorisation issued by the Agency as equivalent to the first authorisation issued in accordance with Article 22 or 24 of Directive 2008/57/EC and issue an additional authorisation in accordance with Article 23 or 25 of Directive 2008/57/EC.
A vehicle authorisation and/or vehicle type authorisation issued by the Agency between 16 June 2020 and 30 October 2020 shall exclude the network or networks in any of the Member States that have notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797. The NSAs of the Member States that have made such a notification shall:
treat a vehicle type authorisation issued by the Agency as equivalent to the authorisation for types of vehicles issued in accordance with Article 26 of Directive 2008/57/EC and apply paragraph 3 of Article 26 of Directive 2008/57/EC as regards that vehicle type;
accept a vehicle authorisation issued by the Agency as equivalent to the first authorisation issued in accordance with Article 22 or 24 of Directive 2008/57/EC and issue an additional authorisation in accordance with Article 23 or 25 of Directive 2008/57/EC.
Applications for an authorisation for placing in service of a vehicle or a type authorisation in accordance with this Regulation shall be accepted by the NSA for the purposes of Directive 2008/57/EC.
Article 56
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 16 June 2019 in the Member States that have not notified the Agency and the Commission in accordance with Article 57(2) of Directive (EU) 2016/797.
It shall apply from 16 June 2020 in the Member States that have notified the Agency and the Commission in accordance with Article 57(2) of Directive (EU) 2016/797 and have not notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797.
Articles 55(5a) and 55(7a) shall apply from 16 June 2020 in all Member States.
Article 55(8) shall apply from 16 June 2020 in Member States that have notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797.
This Regulation shall apply in all the Member States from 31 October 2020.
However, Article 55(1) shall apply from 16 February 2019 in all Member States. The facilitation measures provided in Article 55(2), (3), (4) and (6) shall be made available from 16 February 2019. Article 55(5) shall apply from 16 June 2019 in all Member States.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
Content of the application
1. Type of application (M):
Type authorisation
Vehicle type variants (when applicable)
Vehicle type versions (when applicable)
Authorisation for placing on the market
Single vehicle; or
Series of vehicles
2. Authorisation case (M):
First authorisation
New authorisation
Extended area of use
Renewed type authorisation
Authorisation in conformity to type
3. Area of use (M):
Member States
Networks (per Member State)
Stations with similar network characteristics in neighbouring Member States when those stations are close to the border as specified in Article 21.8 of Directive (EU) 2016/797 (when applicable)
Definition of the extended area of use (only applicable for the authorisation case ‘Extended area of use’)
Whole EU network
4. Issuing authority (M):
The Agency; or
The national safety authority of the Member State (only applicable in case of an area of use limited to one Member State and requested by the applicant as specified in Article 21(8) of Directive (EU) 2016/797)
5. Applicant's information:
Legal denomination (M)
Applicant's name (M)
Acronym (O)
Complete postal address (M)
Phone (M)
Fax (O)
Email (M)
Website (O)
VAT number (O)
Other relevant information (O)
6. Contact person information:
First name (M)
Surname (M)
Title or function (M)
Complete postal address (M)
Phone (M)
Fax (O)
Email (M)
Languages to be used (M)
7. Current vehicle type authorisation holder (not applicable in case of first authorisation) (M):
Legal denomination (M)
Type authorisation holder's name (M)
Acronym (O)
Complete postal address (M)
Phone (M)
Fax (O)
Email (M)
Website (O)
VAT number (M)
Other relevant information (O)
8. Assessment bodies information (M):
Notified body(ies):
Legal denomination (M)
Notified body name (M)
Notified body ID number (M)
Acronym (O)
Complete postal address (M)
Phone (M)
Fax (O)
Email (M)
Website (O)
VAT number (M)
Other relevant information (O)
Designated body(ies):
Legal denomination (M)
Designated body name (M)
Acronym (O)
Complete postal address (M)
Phone (M)
Fax (O)
Email (M)
Website (O)
VAT number (M)
Other relevant information (O)
Assessment body (CSM RA), not applicable for authorisation in conformity to type:
Legal denomination (M)
Assessment body (CSM RA) name (M)
Acronym (O)
Complete postal address (M)
Phone (M)
Fax (O)
Email (M)
Website (O)
VAT number (M)
Other relevant information (O)
9. Pre-engagement:
Reference to pre-engagement baseline (O)
Other relevant project information (O)
10. Description of the vehicle type ((*) to be specified according to Decision 2011/665/EU Annex II) (M):
Type ID (*)
Vehicle type versions (when applicable)
Vehicle type variants (when applicable):
Date of record in ERATV (*) (not applicable for first authorisation)
Type name (*)
Alternative type name (*) (when applicable)
Category (*)
Subcategory (*)
11. Information on the vehicles (to be specified according to Decision 2007/756/EC ( 3 )when available) (M)
EVN numbers or pre-reserved vehicle numbers
Other specification of the vehicles when EVN numbers or pre-reserved vehicle numbers are not available
12. Reference to existing vehicle type authorisation (not applicable in case of first authorisation) (M)
13. Description of the changes as compared to the authorised vehicle type (only applicable in case of a new authorisation) (M)
14. Conditions for use of the vehicle and other restrictions (to be specified according to Decision 2011/665/EU Annex II) (M):
Coded restrictions
Non-coded restrictions
15. CCS additional functions (M)
16. Applicable rules (M):
TSIs, including the legal reference in the Official Journal of the European Union
Specific TSIs clauses for an area of use covering the whole EU network (when applicable)
Specification of the selection of requirements from a newer version of a TSI as compared to the TSI applicable for the assessment (including withdrawn requirements) (when applicable)
National rules (when applicable)
Non-applications of TSIs according to the provisions of Article 7 of Directive (EU) 2016/797 (when applicable)
Applicable rules for the extended area of use.
Updated TSIs and/or national rules (only applicable for renewed type authorisation)
17. Applicant's confirmation and signature (M)
18. Annexes (M):
The information that shall be included in the application is specified per authorisation case. An (x) in the column for the applicable authorisation case indicates that the information is mandatory (M) for this authorisation case.
|
|
|
First authorisation |
Renewed type authorisation |
Extended area of use |
New authorisation |
Authorisation in conformity to type |
|
18.1 |
The supporting evidence for the requirements capture in accordance with Article 13(1). If the applicant uses the methodology set out in Annex I of Regulation (EU) No 402/2013, the supporting evidence consists of the declaration by the proposer referred to in Article 16 of Regulation (EU) No 402/2013 and the safety assessment report referred to in Article 15 of Regulation (EU) No 402/2013. If another methodology is used, the evidence required is that necessary to demonstrate that it provides the same level of assurance as the methodology set out in Annex I of Regulation (EU) No 402/2013. |
X |
|
X |
X |
|
|
18.2 |
Mapping table indicating where the information needed for the aspects to be assessed according to Annex II and III can be found |
X |
X |
X |
X |
|
|
18.3 |
The relevant decisions for non-application of TSIs according to Article 7 of Directive (EU) 2016/797 (when applicable) |
X |
X |
X |
X |
X |
|
18.4 |
Declaration of conformity to the type and associated documentation (Article 24 Directive (EU) 2016/797) |
|
|
|
|
X |
|
18.5 |
EC Declarations of Verification for the mobile subsystems, including accompanying technical files (Article 15 Directive (EU) 2016/797). |
X |
X |
X |
X |
|
|
18.6 |
The file accompanying the application and the decision from the previous authorisation or when applicable the reference to the decision issued according to Article 46 and to the full accompanying file for the decision archived in the one-stop shop. |
|
X |
X |
X |
|
|
18.7 |
Specification of and where applicable (1) a description of the methodology used for the requirements capture for the: (a) essential requirements for subsystems as specified in Article 3 and Annex III of 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. |
X |
|
X |
X |
|
|
18.8 |
CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the requirements capture for the essential requirements ‘safety’ for the subsystems and safe integration between subsystems. |
X |
|
X |
X |
|
|
18.9 |
When not fully covered by TSIs and/or national rules, the documentary evidence of the technical compatibility of the vehicle with the network in the area of use. |
X |
|
X |
X |
|
|
18.10 |
Risk declaration (Article 16 Regulation (EU) No 402/2013) covering the requirements capture for the essential requirements ‘safety’ for the subsystems and safe integration between subsystems for aspects not covered by the TSIs and the national rules. |
X |
|
X |
X |
|
|
18.11 |
CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the potential modification of the overall safety level for the vehicle |
|
|
X |
X |
|
|
18.12 |
Risk declaration (Article 16 Regulation (EU) No 402/2013) covering the potential modification of the overall safety level for the vehicle |
|
|
X |
X |
|
|
18.13 |
Information required for ERATV (according to Annex II of Decision 2011/665/EU) |
X |
|
X |
X |
|
|
18.14 |
Maintenance & operation documentation (including rescue), when not included in 18.4 and/or 18.5. |
X |
|
X |
X |
|
|
(1)
Non standardised methodology |
||||||
ANNEX II
Aspects for assessment by the authorising entity
The information that shall be assessed by the authorising entity is specified per authorisation case. An (x) in the column for the applicable authorisation case indicates that this aspect is mandatory to assess for this authorisation case.
|
|
|
First authorisation |
Renewed type authorisation |
Extended area of use |
New authorisation |
Authorisation in conformity to type |
|
1 |
Application consistent with the pre-engagement baseline (when applicable) |
X |
X |
X |
X |
X |
|
2 |
Authorisation case selected by the applicant is adequate |
X |
X |
X |
X |
X |
|
3 |
The TSIs and other applicable Union law identified by the applicant are correct |
X |
X |
X |
X |
|
|
4 |
Selected conformity assessment bodies (notified body(ies), assessment body (CSM RA)) have the proper accreditation or recognition as applicable |
X |
X |
X |
X |
|
|
5 |
Non-applications of TSIs according to the provisions of Article 7 of Directive (EU) 2016/797: 5.1. Validity (time and area of use); 5.2. Applicable to the project; and 5.3. Consistent with the identified and applied rules. |
X |
X |
X |
X |
X |
|
6 |
6.1. Is the applied methodology used for the requirements capture fit for purpose concerning the following aspects: (a) Has a standardised/accepted methodology been used?; and (b) Is the method intended for and suitable for the essential requirements it covers? 6.2. When the methodology applied is not standardised or covers other essential requirements than it is intended for, the following aspects shall be checked to evaluate if they are sufficiently considered and covered by the methodology: (a) Degree of independent assessment applied (b) System definition (c) Hazard identification and classification (d) Risk acceptance principles (e) Risk evaluation (f) Requirements established (g) Demonstration of compliance with the requirements (h) Hazard management (log) |
X |
|
X |
X |
|
|
7 |
Sufficient evidence from the methodology used for the requirements capture: 7.1. When the risk management process set out in Annex I of Regulation (EU) No 402/2013, has been used as the methodology for requirements capture the following shall be checked: (a) CSM on risk assessment, declaration by the proposer (Article 16 Regulation (EU) No 402/2013) is signed by the proposer and supports that all identified hazards and associated risks are controlled to an acceptable level. (b) CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) supports the declaration by the proposer for the specified scope according to Article 13 and at least the essential requirement safety for subsystems and safe integration between subsystems within the vehicle. 7.2. When another methodology than the risk management process set out in Annex I of Regulation (EU) No 402/2013, has been used as the methodology for requirements capture the following shall be checked: (a) System definition is complete and consistent with the design of the vehicle? (b) Hazard identification and classification is consistent and plausible? (c) All risks have been properly managed and mitigated? (d) Requirements derived from the risk management are properly traced to the risk and to the evidence of compliance with the requirement? (e) Structured and consistent management of the hazards throughout the process? (f) Is there a positive opinion from the independent assessment? |
X |
|
X |
X |
|
|
8 |
EC Declarations of Verification and EC certificates (Article 15 Directive (EU) 2016/797), check: 8.1. Signatures 8.2. Validity 8.3. Scope 8.4. Conditions for use of the vehicle and other restrictions, non-compliances 8.5. Non-application of TSIs (when applicable) 8.6. All applicable legislation is covered, including other non-railway related legislation 8.7. Interoperability constituents (validity, scope, conditions for use and other restrictions): (a) EC certificates of conformity (b) EC certificates of suitability of use |
X |
X |
X |
X |
|
|
9 |
Reports from Conformity assessment bodies (Article 15 Directive (EU) 2016/797), check: 9.1. Consistency with EC Declarations of Verification and EC certificates 9.2. All applicable rules are covered 9.3. Deviations & non-conformities (when applicable) are identified and match the non-application requests 9.4. Combination of modules used is allowed 9.5. Conditions for use of the vehicle and other restrictions are properly identified and are consistent with the conditions in the application for authorisation 9.6. The supporting evidences used by the conformity assessment bodies are matching the applicable assessment phases described in TSIs (design review, type test, etc.). |
X |
X |
X |
X |
|
|
10 |
Check of assessments from NSAs for the area of use, as specified in Article 43 |
X |
X |
X |
X |
|
|
11 |
Validity of the original vehicle type authorisation |
|
X |
X |
X |
X |
|
12 |
Original vehicle type authorisation is valid for the concerned area of use |
|
X |
|
X |
X |
|
13 |
Existing conditions for use of the vehicle and other restrictions |
|
X |
X |
X |
|
|
14 |
CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the requirements capture for the essential requirements ‘safety’ for the subsystems and safe integration between subsystems positive opinion. |
X |
|
X |
X |
|
|
15 |
CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the potential modification of the overall safety level for the vehicle (significant change) positive opinion |
|
|
X |
X |
|
|
16 |
Changes as compared to the authorised vehicle type are sufficiently described and match the CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) |
|
|
|
X |
|
|
17 |
EC Declarations of Verification and EC certificates are properly updated in relation to the changed and/or updated rules |
|
X |
|
|
|
|
18 |
Reports from conformity assessment bodies are properly updated in relation to the changed and/or updated rules: 18.1 Changed and/or updated rules are covered 18.2 There is evidence that the vehicle type still fulfils the requirements |
|
X |
|
|
|
|
19 |
Evidence that the design of the vehicle type has not changed |
|
X |
X |
|
|
|
20 |
Identification of the vehicle or series of vehicles covered by the declaration of conformity to the vehicle type |
|
|
|
|
X |
|
21 |
Declaration of conformity to the type and supporting documents (Article 24 Directive (EU) 2016/797) |
|
|
|
|
X |
ANNEX III
Aspects for assessment by the concerned NSAs for the area of use
This Annex is not applicable when the area of use covers the whole EU network and the TSIs contain specific conditions for this.
The information that shall be assessed by the concerned NSAs for the area of use in relation to the relevant national rules is specified per authorisation case. An (x) in the column for the applicable authorisation case indicates that this aspect is mandatory to assess for this authorisation case
|
|
|
First authorisation |
New authorisation |
Extended area of use |
Renewed type authorisation |
|
1 |
Application consistent with the pre-engagement baseline (when applicable) |
X |
X |
X |
X |
|
2 |
The area of use for the concerned Member State is correctly specified |
X |
X |
X |
X |
|
3 |
The national rules and requirements for the concerned area of use identified by the applicant are correct. |
X |
X |
X |
|
|
4 |
Selected conformity assessment bodies relevant for the concerned area of use (designated body(ies), assessment body (CSM RA)) have the proper accreditation or recognition as applicable. |
X |
X |
X |
X |
|
5 |
Sufficient evidence from the methodology used for the requirements capture only for the national rules for the concerned area of use: 5.1. When another methodology than the risk management process set out in Annex I of Regulation (EU) No 402/2013, has been used as the methodology for requirements capture the following shall be checked: (a) System definition is complete and consistent with the design of the vehicle? (b) Hazard identification and classification is consistent and plausible? (c) All risks have been properly managed and mitigated? (d) Requirements derived from the risk management are properly traced to the risk and to the evidence of compliance with the requirement? |
X |
X |
X |
|
|
6 |
EC Declarations of Verification and Certificates (national rules) (Article 15 Directive (EU) 2016/797), check: 6.1. Signatures 6.2. Validity 6.3. Scope 6.4. Conditions for use of the vehicle, other restrictions, non-compliances |
X |
X |
X |
X |
|
7 |
Reports from conformity assessment bodies (Article 15 Directive (EU) 2016/797), check: 7.1. Consistency with EC Declarations of Verification and certificates. 7.2. Deviations & non-conformities (when applicable) are identified 7.3. Conditions for use and other restrictions are properly identified and are consistent with the conditions in the application for authorisation. 7.4. The supporting evidences used by conformity assessment bodies are matching the applicable assessment phases described in national rules. |
X |
X |
X |
X |
|
8 |
Existing conditions for use of the vehicle and other restrictions |
|
X |
X |
X |
|
9 |
CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the requirements capture for the essential requirements ‘safety’ for the subsystems and safe integration between subsystems positive opinion. |
X |
X |
X |
|
|
10 |
CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the potential modification of the overall safety level for the vehicle (significant change) positive opinion |
|
X |
X |
|
|
11 |
Changes as compared to the authorised vehicle type are sufficiently described and match the CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) |
|
X |
|
|
|
12 |
EC Declarations of Verification and EC certificates are properly updated in relation to the changed/updated national rules |
|
|
|
X |
|
13 |
Reports from conformity assessment bodies are properly updated in relation to the changed/updated rules: 13.1. Changed/updated national rules are covered 13.2. There is evidence that the vehicle type still fulfils the requirements |
|
|
|
X |
( 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).
( 2 ) Commission Implementing Decision 2011/665/EU of 4 October 2011 on the European register of authorised types of railway vehicles (OJ L 264, 8.10.2011, p. 32).
( 3 ) Commission Decision 2007/756/EC of 9 November 2007 adopting a common specification of the national vehicle register provided for under Articles 14(4) and (5) of Directives 96/48/EC and 2001/16/EC (notified under document number C(2007) 5357) (OJ L 305, 23.11.2007, p. 30).