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
Article 2
Definitions
Article 3
Responsibilities of the applicant
Article 4
Responsibilities of the authorising entity
Article 5
Responsibilities of the holder of the vehicle type authorisation
Article 6
Responsibilities of the infrastructure manager
Article 7
Responsibilities of the NSAs for the area of use
Article 8
Responsibilities of the Agency
Article 9
Use of an authorised vehicle
Article 10
Language
Article 11
Vehicle authorisation process for tram-trains in the Single European Railway Area
Article 12
Cross-border agreements
CHAPTER 2
PREPARATION OF THE APPLICATION
Article 13
Requirements capture
Article 14
Identification of the relevant authorisation
Article 15
Changes to an already authorised vehicle type
Article 16
Changes to an already authorised vehicle
Article 17
Identification of the rules including non-application of TSIs
Article 18
Identification and definition of 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
Article 21
Identification of the conformity assessments
CHAPTER 3
PRE-ENGAGEMENT
Article 22
Pre-engagement
Article 23
Pre-engagement file
Article 24
Pre-engagement baseline
CHAPTER 4
CONFORMITY ASSESSMENT
Article 25
Conformity assessment
Article 26
Perform verifications and establish evidence
Article 27
Correction of non-conformities
CHAPTER 5
SUBMITTING THE APPLICATION
Article 28
Establishment of evidence for the application
Article 29
The compilation of the file accompanying the application
Article 30
Application content and completeness
Article 31
The submission of the application for authorisation through the one-stop shop
CHAPTER 6
PROCESSING THE APPLICATION
Article 32
Application completeness check
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
Article 37
Coordination between the authorising entity and the concerned NSAs for the area of use for the assessment of the application
Article 38
Assessment of the application
Article 39
The assessment of the application by the authorising entity
Article 40
The assessment of the application by the concerned NSAs for the area of use
Article 41
Categorisation of issues
Article 42
Justified doubt
Article 43
The checks to be performed by the authorising entity concerning the assessments performed by the concerned NSAs for the area of use
Article 44
Arbitration under Article 21(7) of Directive (EU) 2016/797 and Article 12(4)(b) of Regulation (EU) 2016/796
Article 45
Conclusion of the assessment of the application
Article 46
Decision for the authorisation or the refusal of the application
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
Article 49
The information in the issued vehicle authorisation for placing on the market
Article 50
Registration in ERATV and ERADIS
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
Article 56
Entry into force and application
ANNEX I
Content of the application
1.
Type of application (M):
2.
Authorisation case (M):
3.
Area of use (M):
4.
Issuing authority (M):
5.
Applicant's information:
6.
Contact person information:
7.
Current vehicle type authorisation holder (not applicable in case of first authorisation) (M):
8.
Assessment bodies information (M):
9.
Pre-engagement:
10.
Description of the vehicle type (
(*)
to be specified according to Decision 2011/665/EU Annex II) (M):
11.
Information on the vehicles (to be specified according to Decision 2007/756/EC
(1)
when available) (M)
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):
15.
CCS additional functions (M)
16.
Applicable rules (M):
17.
Applicant's confirmation and signature (M)
18.
Annexes (M):
|
|
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(2) a description of the methodology used for the requirements capture for the:
|
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 |
|
ANNEX II
Aspects for assessment by the authorising entity
|
|
First authorisation |
Renewed type authorisation |
Extended area of use |
New authorisation |
Authorisation in conformity to type |
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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:
|
X |
X |
X |
X |
X |
||||||||||||||||||||||||
6 |
|
X |
|
X |
X |
|
||||||||||||||||||||||||
7 |
Sufficient evidence from the methodology used for the requirements capture:
|
X |
|
X |
X |
|
||||||||||||||||||||||||
8 |
EC Declarations of Verification and EC certificates (Article 15 Directive (EU) 2016/797), check:
|
X |
X |
X |
X |
|
||||||||||||||||||||||||
9 |
Reports from Conformity assessment bodies (Article 15 Directive (EU) 2016/797), check:
|
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:
|
|
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
|
|
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:
|
X |
X |
X |
|
||||||||||
6 |
EC Declarations of Verification and Certificates (national rules) (Article 15 Directive (EU) 2016/797), check:
|
X |
X |
X |
X |
||||||||||
7 |
Reports from conformity assessment bodies (Article 15 Directive (EU) 2016/797), check:
|
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:
|
|
|
|
X |