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. )

Type Implementing Regulation
Publication 2018-04-06
Last updated 2020-06-16
State In force
Department European Commission, MOVE
Source EUR-Lex
articles 57
Reform history JSON API
7.

The final decision to issue the vehicle type authorisation and/or vehicle authorisation for placing on the market or to refuse the application shall be recorded in the one-stop shop and communicated together with the assessment files through the one-stop shop to the applicant and the concerned NSAs for the area of use.

8.

Where the decision either refuses the application or issues the vehicle type authorisation and/or vehicle authorisation for placing on the market subject to different conditions for use of the vehicle and other restrictions when compared to those specified by the applicant in its application, the applicant may request that the authorising entity reviews its decision in accordance with Article 51 of this Regulation. Where the applicant is not satisfied with the reply of the authorising entity, it may bring an appeal before the competent authority in accordance with Article 21(11) of Directive (EU) 2016/797.

CHAPTER 7 FINAL DOCUMENTATION

Article 47

Final documentation for the vehicle type authorisation and/or vehicle authorisation for placing on the market
1.

A vehicle type authorisation and/or vehicle authorisation for placing on the market shall take the form of a document containing the information referred to in Article 48 and/or Article 49.

2.

The issued vehicle type authorisation and/or vehicle authorisation for placing on the market shall be assigned a unique European identification number (‘EIN’) of which the structure and content are defined and administrated by the Agency.

3.

Different conditions for use of the vehicle and other restrictions when compared to those specified by the applicant in its application may be included in the vehicle type authorisation and/or vehicle authorisation for placing on the market.

4.

The authorising entity shall date and duly sign the vehicle type authorisation and/or vehicle authorisation for placing on the market.

5.

The authorising entity shall ensure that the decision issued in accordance with Article 46 and the full accompanying file for that decision are archived pursuant to Article 52.

Article 48

The information in the issued vehicle type authorisation

The vehicle type authorisation issued by the authorising entity shall contain the following information:

  • (a) the legal basis empowering the authorising entity to issue the vehicle type authorisation;
  • (b) identification of:
  • (i) the authorising entity;
  • (ii) the application;
  • (iii) authorisation case as specified in Article 14;
  • (iv) the applicant for the vehicle type authorisation;
  • (v) the EIN associated to the vehicle type authorisation;
  • (c) an identification of the basic design characteristics of the vehicle type:
  • (i) stated in the type and/or design examination certificates;
  • (ii) the area of use of the vehicle;
  • (iii) the conditions for use of the vehicle and other restrictions;
  • (iv) 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;
  • (d) an identification of:
  • (i) the vehicle type ID, in accordance with Annex II to Commission Implementing Decision 2011/665/EU ([^E0002]);
  • (ii) the vehicle type variants, where applicable;
  • (iii) the vehicle type versions, where applicable;
  • (iv) 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;
  • (v) 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);
  • (e) reference to the EC declarations of verification for the subsystems;
  • (f) reference to other Union or national law with which the vehicle type is compliant;
  • (g) reference to the documented reasons for the decision referred to in Article 45(5);
  • (h) date and place of the decision to issue the vehicle type authorisation;
  • (i) signatory of the decision to issue the vehicle type authorisation; and
  • (j) 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:

  • (a) the legal basis empowering the authorising entity to issue the vehicle authorisation for placing on the market;
  • (b) identification of the:
  • (i) authorising entity;
  • (ii) application;
  • (iii) authorisation case as specified in Article 14;
  • (iv) applicant for the vehicle authorisation for placing on the market;
  • (v) EIN associated to the vehicle authorisation for placing on the market;
  • (c) the reference to the vehicle type registration in ERATV, including the information on the vehicle type variant and/or vehicle type version, when applicable;
  • (d) identification of the:
  • (i) vehicles;
  • (ii) areas of use;
  • (iii) conditions for use of the vehicle and other restrictions;
  • (e) reference to the EC declarations of verification for the subsystems;
  • (f) reference to other Union or national law with which the vehicle is compliant;
  • (g) reference to the documented reasons for the decision referred to in Article 45(5);
  • (h) 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;
  • (i) the date and place of the decision to issue the vehicle authorisation for placing on the market;
  • (j) the signatory of the decision to issue the vehicle authorisation for placing on the market; and
  • (k) 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
1.

The ERATV shall be completed by the authorising entity using the information provided by the applicant as part of the vehicle type authorisation application. The applicant shall be responsible for the integrity of the data provided to the authorising entity. The authorising entity shall be responsible for checking the consistency of the data provided by the applicant and making the ERATV entry available to the public.

2.

The authorising entity shall ensure that the European Railway Agency Database of Interoperability and Safety (‘ERADIS’) has been updated as appropriate before delivering a vehicle type authorisation and/or vehicle authorisation for placing on the market

3.

For modifications pursuant to Article 15(1)(c) and 15(3), the authorising entity shall register in ERATV the new version of a vehicle type or the new version of a vehicle type variant, using the information provided by the holder of the vehicle type authorisation. The holder of the vehicle type authorisation is responsible for the integrity of the data provided to the authorising entity. The authorising entity shall be responsible for checking the consistency of the data provided by the holder of the vehicle type authorisation and making the ERATV entry available to the public.

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
1.

Where the decision of the authorising entity contains a refusal or different conditions for use of the vehicle and other restrictions when compared to those specified by the applicant in its application, the applicant may request the review of the decision within one month from the date of its receipt. That request shall be submitted by the applicant through the one-stop shop.

2.

The request for review shall include a list of issues that, in the view of the applicant, have not been properly taken into consideration during the vehicle authorisation process

3.

Any supplementary information which has been developed and filed through the one-stop shop after the date of issuing of the authorisation decision shall not be admissible as evidence.

4.

The authorising entity, where applicable in coordination with relevant NSAs for the area of use, shall ensure impartiality of the review process.

5.

The review process shall address the issues justifying the negative decision of the authorising entity in accordance with the applicant's request.

6.

Where the Agency acts as the authorising entity, a decision to reverse or not its decision shall be subject to review in coordination with the relevant NSAs for the area of use, where applicable.

7.

The authorising entity shall confirm or reverse its first decision within two months from the date of receipt of the request for review. That decision shall be communicated to the relevant parties through the one-stop shop.

Article 52

Archiving of a decision and the full accompanying file for the decision issued in accordance with Article 46
1.

The decision and the full accompanying file for the decision issued in accordance with Article 46 shall be retained in the one-stop shop for at least 15 years.

2.

The full accompanying file for the decision of the authorisation entity issued in accordance with Article 46 shall include all documents used by the authorising entity and the assessment files of the concerned NSAs for the area of use.

3.

After the expiry of the retention time set out in paragraph 1, the decision given in accordance with Article 46 for the issue of a vehicle type authorisation and/or a vehicle authorisation for placing on the market, and its full accompanying file shall be moved to a historical archive and kept for a period of five years after the termination of the service life of the vehicle, as recorded in the register referred to in Article 47 of Directive (EU) 2016/797.

CHAPTER 8 SUSPENSION OR REVOCATION OR AMENDMENT OF AN ISSUED AUTHORISATION

Article 53

Suspension, revocation or amendment of an issued authorisation
1.

Temporary safety measures in the form of suspension of a vehicle type authorisation may be applied by the authorising entity in accordance with Article 26(3) of Directive (EU) 2016/797.

2.

In the cases referred to in Article 26(3) of Directive (EU) 2016/797 and following a review of the measures taken to address the serious safety risk, the authorising entity that issued the authorisation may decide to revoke or amend the authorisation in accordance with Article 26(4) of Directive (EU) 2016/797.

3.

The applicant may launch an appeal against the decision to revoke or amend an authorisation in accordance with Article 26(5) of Directive (EU) 2016/797.

4.

The authorising entity shall inform the Agency where there is a decision to revoke or amend an authorisation and give the reasons for its decision. The Agency shall inform all NSAs of the decision to revoke or amend an authorisation and the reasons for the decision.

Article 54

The effect of suspension or revocation or amendment of an issued authorisation on the registration in ERATV, ERADIS and vehicle registers
1.

When the authorising entity takes a decision to revoke, suspend or amend a vehicle type authorisation it shall update the ERATV accordingly, subject to the provisions of Article 26(4) of Directive (EU) 2016/797, and ensure that ERADIS is updated accordingly.

2.

The Member State where the vehicle is registered shall ensure that any decision to revoke or amend a vehicle type authorisation and/or a vehicle authorisation for placing on the market is reflected in the register referred to in Article 47 of Directive (EU) 2016/797.

CHAPTER 9 FINAL PROVISIONS

Article 55

Transitional provisions
1.

Where a NSA recognises that it will not be able to issue a vehicle authorisation in accordance with Directive 2008/57/EC before the relevant date in the Member State concerned, it shall inform the applicant and the Agency immediately.

2.

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:

  • (a) 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;
  • (b) 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.
3.

Where the area of use is not limited to one Member State, the authorising entity shall be the Agency and the procedure set out in point (a) of paragraph 2 applies.

4.

In cases referred to in paragraphs 2 and 3, the applicant shall submit a revised application for a vehicle type authorisation and/or a vehicle authorisation for placing on the market by means of the one-stop shop, in accordance with this Regulation. The applicant may request assistance for supplementing the file from the authorising entities involved.

4a. Notwithstanding paragraphs 1 to 4, in those Member States that have notified the Agency and the Commission in accordance with Article 57(2) of Directive (EU) 2016/797 and where Directive (EU) 2016/797 shall apply from 16 June 2020, the NSA shall, at the request of the applicant, continue to carry out the assessment of the applications for a vehicle type authorisation and/or a vehicle authorisation for placing on the market in accordance with Directive 2008/57/EC, beyond 16 June 2020, provided that it shall issue the vehicle type authorisation and/or vehicle authorisation before 30 October 2020.

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.

5.

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:

  • (a) 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;
  • (b) 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.

5a. 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:

  • (a) 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;
  • (b) 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.
6.

In cases referred to in point (a) of paragraph 2 and in paragraphs 5 and 5a, the NSA shall cooperate and coordinate with the Agency to undertake the assessment of the elements set out in point (a) of Article 21(5) of Directive (EU) 2016/797.

7.

Freight wagons compliant with paragraph 7.1.2 of the Annex of WAG TSI Regulation (EU) No 321/2013 and with a vehicle authorisation for placing on the market shall be treated between 16 June 2019 and 16 June 2020 as vehicle with an authorisation for placing into service for the purpose of Directive 2008/57/EC by 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.

7a. Freight wagons compliant with paragraph 7.1.2 of the Annex of WAG TSI Regulation (EU) No 321/2013 and with a vehicle authorisation for placing on the market shall be treated between 16 June 2020 and 30 October 2020 as vehicles with an authorisation for placing into service for the purpose of Directive 2008/57/EC by Member States that have notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797.

8.

Between 16 June 2020 and 30 October 2020, in Member States that have notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797, applicants for an authorisation for placing in service of a vehicle or a type authorisation for the purposes of Directive 2008/57/EC may submit to the national safety authority a file concerning the vehicle or vehicle type compiled in accordance with Articles 29(1) and 30(1) and complying with Annex I.

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

(M) means required information to be submitted by the applicant.

(O) means optional information that may still be submitted by the applicant.

1. Type of application (M):

  • 1.1. Type authorisation
  • (a) Vehicle type variants (when applicable)
  • (b) Vehicle type versions (when applicable)
  • 1.2. Authorisation for placing on the market
  • (a) Single vehicle; or
  • (b) Series of vehicles

2. Authorisation case (M):

  • 2.1. First authorisation
  • 2.2. New authorisation
  • 2.3. Extended area of use
  • 2.4. Renewed type authorisation
  • 2.5. Authorisation in conformity to type

3. Area of use (M):

  • 3.1. Member States
  • 3.2. Networks (per Member State)
  • 3.3. 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)
  • 3.4. Definition of the extended area of use (only applicable for the authorisation case ‘Extended area of use’)
  • 3.5. Whole EU network

4. Issuing authority (M):

  • 4.1. The Agency; or
  • 4.2. 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:

  • 5.1. Legal denomination (M)
  • 5.2. Applicant's name (M)
  • 5.3. Acronym (O)
  • 5.4. Complete postal address (M)
  • 5.5. Phone (M)
  • 5.6. Fax (O)
  • 5.7. Email (M)
  • 5.8. Website (O)
  • 5.9. VAT number (O)
  • 5.10. Other relevant information (O)

6. Contact person information:

  • 6.1. First name (M)
  • 6.2. Surname (M)
  • 6.3. Title or function (M)
  • 6.4. Complete postal address (M)
  • 6.5. Phone (M)
  • 6.6. Fax (O)
  • 6.7. Email (M)
  • 6.8. Languages to be used (M)

7. Current vehicle type authorisation holder (not applicable in case of first authorisation) (M):

  • 7.1. Legal denomination (M)
  • 7.2. Type authorisation holder's name (M)
  • 7.3. Acronym (O)
  • 7.4. Complete postal address (M)
  • 7.5. Phone (M)
  • 7.6. Fax (O)
  • 7.7. Email (M)
  • 7.8. Website (O)
  • 7.9. VAT number (M)
  • 7.10. Other relevant information (O)

8. Assessment bodies information (M):

  • 8.1. Notified body(ies):
  • (a) Legal denomination (M)
  • (b) Notified body name (M)
  • (c) Notified body ID number (M)
  • (d) Acronym (O)
  • (e) Complete postal address (M)
  • (f) Phone (M)
  • (g) Fax (O)
  • (h) Email (M)
  • (i) Website (O)
  • (j) VAT number (M)
  • (k) Other relevant information (O)
  • 8.2. Designated body(ies):
  • (a) Legal denomination (M)
  • (b) Designated body name (M)
  • (c) Acronym (O)
  • (d) Complete postal address (M)
  • (e) Phone (M)
  • (f) Fax (O)
  • (g) Email (M)
  • (h) Website (O)
  • (i) VAT number (M)
  • (j) Other relevant information (O)
  • 8.3. Assessment body (CSM RA), not applicable for authorisation in conformity to type:
  • (a) Legal denomination (M)
  • (b) Assessment body (CSM RA) name (M)
  • (c) Acronym (O)
  • (d) Complete postal address (M)
  • (e) Phone (M)
  • (f) Fax (O)
  • (g) Email (M)
  • (h) Website (O)
  • (i) VAT number (M)
  • (j) Other relevant information (O)

9. Pre-engagement:

  • 9.1. Reference to pre-engagement baseline (O)
  • 9.2. Other relevant project information (O)

10. Description of the vehicle type ((*) to be specified according to Decision 2011/665/EU Annex II) (M):

  • 10.1. Type ID (*)
  • 10.2. Vehicle type versions (when applicable)
  • 10.3. Vehicle type variants (when applicable):
  • 10.4. Date of record in ERATV (*) (not applicable for first authorisation)
  • 10.5. Type name (*)
  • 10.6. Alternative type name (*) (when applicable)
  • 10.7. Category (*)
  • 10.8. Subcategory (*)

11. Information on the vehicles (to be specified according to Decision 2007/756/EC ([^E0003])when available) (M)

  • 11.1. EVN numbers or pre-reserved vehicle numbers
  • 11.2. 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):

  • 14.1. Coded restrictions
  • 14.2. Non-coded restrictions

15. CCS additional functions (M)

16. Applicable rules (M):

  • 16.1. TSIs, including the legal reference in the Official Journal of the European Union
  • 16.2. Specific TSIs clauses for an area of use covering the whole EU network (when applicable)
  • 16.3. 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)
  • 16.4. National rules (when applicable)
  • 16.5. Non-applications of TSIs according to the provisions of Article 7 of Directive (EU) 2016/797 (when applicable)
  • 16.6. Applicable rules for the extended area of use.
  • 16.7. 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 [^E0004] 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

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

[^E0001]: 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).

[^E0002]: 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).

[^E0003]: 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).

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