EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the templates for ‘EC’ declarations and certificates for railway interoperability 
constituents and subsystems on the model of declaration of conformity to an authorised 
railway vehicle type and on the ‘EC’ verification procedures for subsystem in 
accord ance with Directive (EU) 2016/797 of the European Parliament and of the Council 
and repealing Regulation (EU) No 201/2011  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commissi on services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the templates for ‘EC’ declarations and certificates for railway interoperability 
constituents and subsystems on the model of declaration of conformity to an authorised 
railway vehicle type and on the ‘EC’ verification procedures for subsystem in 
accord ance with Directive (EU) 2016/797 of the European Parliament and of the Council 
and repealing Regulation (EU) No 201/2011  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Directive (EU) 2016/7 97 of the European Parliament and of the Council of 
11 May 2016 on the interoperability of the rail system within the European Union1, and in 
particular Article 9( 4), Article 15(9) and Article 24(4) thereof,  
Whereas:  
(1) Manufacturers or their authorised representatives, applicants, notified bodies and 
designated bodies should use harmonised templates  for documents that accompany the 
application for an authorisation for the placing  in service of fixed installations or a 
vehicle authorisation of placing  on the market in order t o streamline the assessment by 
the European Union Agency for Railways ('the Agency') or a national safety authority 
of those applications and in order to facilitate the supervision of the Union rail system  
by national safety authori ties. 
(2) There is a need to facilitate the establishment  of ‘EC’  declarations provided for in 
Directive (EU) 2016/797 . In particular, there is a need to facilitate the establishment of 
‘EC’ declaration s of conformity or suitability for use of interoperability  constituents , 
‘EC’ declaration s of verification  of subsystems, intermediate statement of verification  
of subsystems, declaration of conformity to an authorised  vehicle type .  
(3) There is also a need to facilitate the establish ment of the technical file that is to 
accompany the ‘EC’ declarations by setting templates for  ‘EU’ certificate of 
conformity  or suitability for use of an interoperability constituent , ‘EU’ certificate of 
verification of a subsystem  delivered by a notified body and certificate delivered by a 
designated body .  
(4) ‘EC’ declaration of conformity and ‘EC’ declaration of suitability for use and their 
accompanying documents should provide evidence that the interoperability 
constituents have been subject to the procedures lai d down in the corresponding 
technical specifications for interoperability  ('TSI ') for assessing conformity or 
suitability for use  and indicate the references of those TSIs and other relevant Union 
acts.  
(5) An ‘EC’ declaration of suitability for  use of intero perability constituents being  issued 
on the  basis of in -service experience  should be considered  as a supplementary 
declaration to the ‘EC’ declaration of conformity of interoperability constitu ent.  
                                                 
1 OJ L 138, 26.5.2016, p. 44 .  
EN 2  EN (6) The nature of information to be provided  should allow for  one template to be used to 
accommodate both ‘ EC’ declarations of the conformity of  the interoperability 
constituent  and ‘EC’ declaration s of the suitability for use of the interoperability 
constituent.  
(7) ‘EC’ declarati on of verification of subsystems  and its accompanying documents  
should provide evidence of the completion of the relevant procedures for verification 
in accordance with the applicable Union law and relevant national rules, and indicate 
the references of the Directive s, TSIs and other relevant  Union acts as well as relevant  
national rules.  
(8) In order to ensure that a subsystem continues to meet the essential requirements over 
time the ‘EC’  declaration  of verification should reflect any change which affects it and 
the applicant should have proced ures in place to continuously update the ‘EC’  
declaration  of verification.  
(9) ‘EC’ verification procedure for a modified subsystem should be in accordance  with 
Article 15 of Directive (EU) 2016/797  and provisions applicable to existing 
subsystems and vehicle s which are  set out in TSIs . Existing subsystems may have 
been placed in service before ‘EC’ verification procedure where applicable to them 
and thus without an ‘EC’ d eclaration of verification . ‘EC’ verification procedure 
regarding changes to those subsystems placed in service without an ‘EC’ d eclaration 
of verification  should be limited to the parts of the subsystem that are changed, and 
their interfaces to the unchanged parts of the subsystem . An ‘EC’ declarati on of 
verification should  then cover  the changed subsystem .   
(10) One template should  be used to accommodate the ‘EC’ declaration of verification and 
potential changes that could affect its elements during the lifecycle of the subsystem.  
(11) Interme diate Statement of Verification  of subsystem , its anne x and accompanying 
documentation should provide evidence of the completion of a stage of the relevant 
verification procedure of a subsystem, or of a part of a subsystem, in accordance with 
the applicable Union law and relevant national rules . It should als o indicate the 
references of the Directive s, TSIs and other relevant Union acts as well as relevant  
national rules .  
(12) The n ature of information to be provided allows for o ne template to be used to 
accommodate ‘EU ’ certificate of verification delivered by a notified body for a 
subsystem, ‘E U’ certificate of conformity delivered by a notified body for an 
interoperability constituent, ‘EU ’ certificate of suitability for use delivered by a 
notified body for an interoperability constituent as well as certificate delivered by a 
designated body  for a subsystem .  
(13) The annexes to the declaration of conformity to an authorised  vehicle  type should 
provide evidence of the completion of the relevant procedures for verification in 
accordance with the applicable Union law an d relevant national rules, and indicate the 
references of the Directive s, TSIs and other relevant Union acts as well as relevant  
national rules.   
(14)  On 19 December  2017 , the Agency issued a recommendation on ‘EC’ declaration of 
verification of subsystems an d templates referred to in Article 9(4), Article 15(9) and 
Article 24(4) of Directive (EU) 2016/797.   
EN 3  EN (15) Annexes IV and V to Directive 2008/57/EC of the Europea n Parliament and of the 
Council2 on the content of ‘EC’ declaration of conformity  or suitability for  use and 
‘EC’ declarati on of verification are repealed by Directive (EU) 2016/797 , the 
provisions concerned should therefore be replaced.  
(16) Commission Regulation (EU) No 201/20113 should be repealed.  
(17) The measures provided for in this Decision are in accordan ce with the opinion of the 
Committee referred to in  Article 51(1) of Directive (EU) 2016/797 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Subject matter  
This Regulation lays down:  
(a) the template for the ‘EC’ declaration of conformity or suitability for use of an 
interoperability constituent as referred to in Article 9( 2) of Directive (EU) 2016/797 ; 
(b) the details of the ‘EC’ verification  procedures of subsystems and  the template for the 
‘EC’ declaration of verification as referred to in Article 15(9) of Directive (EU) 
2016/797 ; 
(c) the template for the Intermediate Statement of Verification of the  subsystem as 
referred to in Article 15(9) of Directive (EU) 2016/797 ;  
(d) the template for the certificates of conformity or suitability for use of  an 
interoperability constitue nt as referred to in Article 9( 2) and the template for the  
certificate s of verification of a subsystem as referred to Article 15(9) of Directive 
(EU) 2016/797;  
(e) the model of declaration of conformity to a n authorised  vehicle type as referred to in 
Article 24(4) of Directive (EU) 2016/797.  
 
Article 2  
Definitions  
For the purpose s of this Regulation, the following definitions shall apply:  
(a)  ‘‘EC’ declaration of conformity ’ means the declaration established for an 
interoperability constituent  by the manufacturer or its authorised representative  in 
which the manufacturer or its a uthorised representative  declares on its sole 
responsibility that the interoperability constituent concerned, which has been subject 
to the rel evant verifications procedures , complies with  the relevant Union law ;  
(b) ‘‘EC’ dec laration of suitability for use ’ means the supplementary declaration to the 
‘EC’ declaration of conformity of the interoperability constituent established  for an 
interoperability constituent  by the  manufacturer  or its authorised representative  in 
which the manufacturer or its a uthorised representative  declares on its sole 
                                                 
2 Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the 
interoperability of the rail system within the Community (OJ L 191, 18.7.2008, p. 1). 
3 Commission Regulation (EU) No  201/2011 of 1  March 2011 on the model of declaration of conformity 
to an authorised type of railway vehicle (OJ L 57, 2.3.2011, p. 8 ).  
EN 4  EN responsibility that the interoperability constituent concerned, which has been subject 
to the relevant verification procedure , satisfies the r equirements for suitability for use 
specified in the relevant TSI ; 
(c) “EU’ certificate of conformity’ means the certificate delivered for an interoperability 
constituent by the notified body of the conformity of an interoperability constituent , 
considered in isolation, with Union technical specifications to be met ; 
(d) “EU’ certificate of suitability for use’ means the certificate delivered for an 
interoperability constituent by the notified body of the suitability for use of an 
interoperability con stituent considered within its railway environment ;  
(e) ‘‘EC’ declaratio n of verification ’ means the declaration established for a subsystem 
by the applicant in which the applicant declares on its sole responsibility that the 
subsystem concerned, which has be en subject to the relevant verifications 
procedures, satisfies the requirements of the relevant Union law, any relevant 
national rules and other requirements relevant for compliance with essential 
requirements ; 
(f) ‘Intermediate Statement of Verification’ mean s the document  established either by 
the notified body who selected by the applicant, in the case of TSI requirements, or 
by a designated body, in case of requirements  stemming from  national rules , which  
registers  the results of a stage of the verification  procedure ; 
(g) ‘‘EU’ certificate of verification’ means the certificate delivered for a subsystem by 
the notified body  of verification  of conformity with relevant TSIs  from the design 
stage to the acceptance stage before the subsystem is placed on the market or in 
service  and which cover s verification of the interfaces of the subsystem in question 
with the system into which it is incorporated ; 
(h) ‘certificate of verification ’ means the certificate delivered for a subsystem by the 
designated body  of verification  of conformity with relevant national rules ; 
(i) ‘declaration of conformity to an authorised  vehicle  type’ means  the declaration 
established for a vehicle  by the applicant in which the applicant declares on its sole 
responsibility that  the vehicle  concerned, whi ch has been subject to the relevant 
verification procedures, conforms to an authorised vehicle type and satisfies the 
requirements of the relevant Union l aw and relevant national rules.  
 
Article 3 
‘EC’ declaration  of conformity or  
‘EC’ declaration of suitability for use  
1. The manufacturer or its authorised representative shall establish ‘EC’ declaration of 
conformity of interoperability constituent or ‘EC’ declaration of suitability for use of 
interoperability constituent in accordance with the template set out in Annex I.  
2. ‘EC’ declaration of conformity or ‘EC’ declaration of suitability for use shall be 
written in one of the official languages of the Union and it shall be in the same 
language as its accompanying documents.  
  
EN 5  EN Article 4 
Accompanying documen ts for ‘EC’ declaration of conformity or  
‘EC’ declaration of suitability for use  
The ‘EC’ declaration of conformity or suitability for use of interoperability constituents  shall 
be accompanied by the following documents :  
(a) ‘EU’ certificate of conformity and, where appropriate, ‘EU’ certificate of suitability 
for use’ ; 
(b) technical documentation  in accordance with  Commission Decision 2010/713/EU4.  
 
Article 5 
‘EC’ declaration of verification  
1. ‘EC’ declaration of verification shall be based on the information resulting from the 
verification procedure(s) for subsyst ems set out in Article 15 of  Directive (EU) 
2016/797  and Annex IV to that Directive. One ‘EC’ declaration of verification  shall 
comprise the verification of Union law  and, where appropriate, of national rules.  
2. The applicant shall establish ‘EC’ declaration of verification in accordance with  the 
template set out in Annex II, and in accordance with the template set out in Annex III 
when it relates to a subsystem initially placed in service without an ‘EC’ declaration 
of verification . 
3. ‘EC’ declaration of verification  shall be written in one of the official languages of the 
Union and it shall be in the same language as its accompanying documents.  
 
Article 6 
Verification procedure in case of a change to a  subsystem  
1. In the event  of a change to a subsystem , the applicant shall analyse the change and 
assess the impact on the ‘EC’ declaration of verification .  
2. Where  the validity of an element  of the relevant ‘EC’ declaration of verification is 
impacted by that change , the applicant shall update the ‘EC’  declaration of 
verification or shall establish a new ‘EC’ declaration of verificati on, as appropriate. 
In particular, where the results of the ‘EC’ verification procedure are impacted , the 
applicant  shall carry out the ‘EC’ verification procedure  for the changed subsystem . 
 
 
                                                 
4 Commission Decision 2010/713/EU of 9 November 2010 on modules for the procedures for assessment 
of conformity, suitability for use and EC verification to be used in the technical specifications for 
interoperability adopted under Directive 2008/57/EC of the European Pa rliament and of the Council 
(OJ L 319, 4.12.2010, p. 1) .  
EN 6  EN Article 7 
Verification procedure of s ubsystem s placed in service without an ‘EC’  
declaration  of verification  
1. Where a change is made to a subsystem that requires the verification by a conformity 
assessment body, the ‘EC’  verification procedure shall be followed in accordance 
with Article 15 of Directive (EU) 2016/797.   
2. The conformity assessment body shall only assess the parts of the subsystem that are 
changed, and assess the interfaces to the unchanged parts of the subsystem.   
3. An ‘EC’  declaration of verification shall be established by the applicant for the 
whole subsystem by declaring under its sole responsibility th at:  
(a) the changed part has been subject to the relevant verification procedures and 
complies with the relevant Union law and any relevant national rules.  
(b) the unchanged part has been approved to be used in the railway system and has 
been in use since  the dat e of approval until the date of the establish ment  of EC 
declaration of verification.   
 
Article 8  
Intermediate Statement of Verification  
1. Intermediate Statement of Verification shall be based on the same relevant 
conformity assessment modules as those used for the  issuing of a  certificat e of 
verification for a subsystem.  
2. The notified body or the designated body  shall establish the Intermediate Statement 
of Verification in accordance with  the template set out in Annex I V. 
3. The Intermediate Statement of Verification shall be written in one of the official 
languages of the Union and it shall be in the same language as its accompanying 
documents.  
 
Article 9 
Certificate s of conformity or suitability for use  and of verification  
Certificate s of verification  of subsystem  and ‘EU’ certificate of co nformity or suitability for 
use of interoperability constituent s shall be established  in accordance with the  template set out 
in Annex V.  
 
Article 10 
Declaration of conformity to an authorised  vehicle type 
1. The applicant shall establish declar ation of conformity to an authorised vehicle type 
in accordance with  the model structure set out in Annex VI.  
EN 7  EN 2. Declaration of conformity to an authorised vehicle type shall be written in one of the  
official languages of the Union and it shall be in the same language as its  
accompanying documents . 
 
Article 11 
Repeal  
Regulation (EU) No 201/2011 is repealed with effect from 16 June 20 19.  
The Annex to Regulation (EU) No 201/2011  shall continue to apply to declaration of 
conformity to type as referred to in Article 26(4) of Directive 2008/57/EC  in the Member 
States that have notified the Agency and the Commis sion in accordance with Article  57(2) of 
Directive (EU) 2016/797  until 16  June 2020.  
 
Article 12 
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.  
Article 11 shall apply from 16 June 2019 in the Member States that have notified the Agency 
and the Commission in accordance wi th Article 57(2) of Directive (EU) 2016/797 . 
It shall apply  in all Member States from 16 June 2020.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker