Commission Implementing Regulation (EU) 2019/250 of 12 February 2019 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 subsystems in accordance with Directive (EU) 2016/797 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 201/2011 (Text with EEA relevance.)

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 constituent as referred to in Article 9(2) and the template for the certificates of verification of a subsystem as referred to in Article 15(9) of Directive (EU) 2016/797;

(e) the model of declaration of conformity to an authorised vehicle type as referred to in Article 24(4) of Directive (EU) 2016/797.

Article 2

Definitions

For the purposes 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 authorised representative declares on its sole responsibility that the interoperability constituent concerned, which has been subject to the relevant verification procedures, complies with the relevant Union law;

(b) ‘“EC” declaration 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 authorised representative declares on its sole responsibility that the interoperability constituent concerned, which has been subject to the relevant verification procedures, satisfies the requirements for suitability for use specified in the relevant TSI;

(c) ‘“EC” declaration 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 been subject to the relevant verification procedures, satisfies the requirements of the relevant Union law and any relevant national rules;

(d) ‘Subsystem placed in service without an “EC” declaration of verification’ means a subsystem, fixed or mobile, that has been placed in service before ‘EC’ verification procedure was applicable to it in accordance with Council Directive 96/48/EC (¹), Directive 2001/16/EC of the European Parliament and of the Council (²) or Directive 2008/57/EC, and thus without an ‘EC’ declaration of verification.

(e) ‘Intermediate Statement of Verification’ means the document established either by the notified body selected by the applicant, in the case of TSI requirements, or by a designated body, in the case of requirements stemming from national rules, which registers the results of a stage of the verification procedure;

(f) ‘“EC” 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 the Union technical specifications to be met;

(g) ‘“EC” 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 constituent considered within its railway environment;

(h) ‘certificate of verification’ means the certificate delivered for a subsystem either by the notified body or by the designated body regarding the verification of conformity respectively with relevant TSIs or with relevant national rules from the design stage to the acceptance stage before the subsystem is placed on the market or in service and which covers verification of the interfaces of the subsystem in question with the system into which it is incorporated;

(i) ‘“EC” certificate of verification’ means the certificate delivered for a subsystem by the notified body regarding solely the verification of conformity with relevant TSIs;

(j) ‘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, which has been subject to the relevant verification procedures, conforms to an authorised vehicle type and satisfies the requirements of the relevant Union law and relevant national rules.

(k) ‘ERADIS ID’ means the alphanumeric code used to identify an ‘EC’ declaration of conformity or suitability for use of interoperability constituent or an ‘EC’ declaration of verification of subsystem and which is established in accordance with Annex VII.

Article 3

‘EC’ declaration of conformity or ‘EC’ declaration of suitability for use

Article 4

Accompanying documents for ‘EC’ declaration of conformity or ‘EC’ declaration of suitability for use

An ‘EC’ declaration of conformity or suitability for use of interoperability constituents shall be accompanied by the following documents:

(a) ‘EC’ certificate of conformity and, where appropriate, ‘EC’ certificate of suitability for use;

(b) technical documentation in accordance with Commission Decision 2010/713/EU (³).

Article 5

‘EC’ declaration of verification

Article 6

Verification procedure in case of a change to a subsystem

Article 7

Verification procedure in case of a change to a subsystem placed in service without an ‘EC’ declaration of verification

An ‘EC’ declaration of verification shall be established by the applicant for the whole subsystem by declaring under its sole responsibility that:

(a) the changed part and the interfaces to the unchanged parts of the subsystem have been subject to the relevant verification procedures and comply with the relevant Union law and any relevant national rules.

(b) the unchanged part has been brought into use in the railway system and has been maintained in its design operating state since the date of bringing into use in the railway system until the date of the establishment of EC declaration of verification.

Article 8

Intermediate Statement of Verification

Article 9

Certificate of conformity or suitability for use and of verification

Certificate of verification of subsystem, ‘EC’ certificate of verification and ‘EC’ certificate of conformity or suitability for use of interoperability constituents shall be established in accordance with the template set out in Annex V.

Article 10

Declaration of conformity to an authorised vehicle type

Article 11

Repeal

Regulation (EU) No 201/2011 is repealed with effect from 16 June 2019.

The Annex to Regulation (EU) No 201/2011 shall continue to apply to declaration of conformity to type referred to in Article 26(4) of Directive 2008/57/EC until 15 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 that have not notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797.

The Annex to Regulation (EU) No 201/2011 shall continue to apply to declaration of conformity to type referred to in Article 26(4) of Directive 2008/57/EC until 30 October 2020 in the Member States that have notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797.

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 of an intention to extend the transposition period of Directive (EU) 2016/797 in accordance with Article 57(2) thereof.

This Regulation 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 that have not notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797.

It shall apply in all Member States from 31 October 2020.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

TEMPLATE FOR ‘EC’ DECLARATION OF CONFORMITY OR SUITABILITY FOR USE OF INTEROPERABILITY CONSTITUENTS

‘EC’ declaration of conformity or suitability for use of interoperability constituent

‘EC’ declaration identification number [ERADIS ID] (⁴)

We, Manufacturer or Authorised representative

[Business name]

[Complete postal address]

Declare under our sole responsibility that the following interoperability constituent (⁵):

[Name/short description of interoperability constituent, unique identification of the interoperability constituent]

to which this declaration refers complies with the relevant Union law:

[Title(s) of the Directive(s); Title(s) of the TSI(s); Title(s) of European Specifications]

has been assessed by the following Notified Body:

[Business name]

[Registration number]

[Full address]

In accordance with the following approval(s) and/or certificate(s):

[Approval(s), date of issue][Certificate number(s), date of issue]

The following conditions of use and other restrictions apply (⁶):

[List or reference to the list of conditions of use and other restrictions]

The following procedures have been followed in order to declare conformity:

[The modules chosen by manufacturer for the assessment of the interoperability constituent]

List of Annexes

[Titles of the Annexes (Technical documentation or technical file accompanying the ‘EC’ declaration of conformity or suitability for use)] (⁷)

Done on:

[Date DD/MM/YYYY]

Signature of Manufacturer/Authorised representative

[First Name, Surname]

ANNEX II

TEMPLATE FOR ‘EC’ DECLARATION OF VERIFICATION OF SUBSYSTEM

‘EC’ declaration of verification of subsystem

‘EC’ declaration identification number [ERADIS ID] (⁸)

We, Applicant:

[Business name]

[Complete postal address]

Declare under our sole responsibility that the following subsystem (⁹):

[Name/short description of the subsystem, unique identification of the subsystem]

to which this declaration refers has been subject to the relevant verification procedures and complies with the relevant Union law and any relevant national rules:

[Reference to: the Directive(s); TSI(s); Relevant national rules;]

has been assessed by the following conformity assessment bodies:

Notified Body: Business name Registration number Full address	Designated Body: Business name Identification number Full address	Assessment body [Risk assessment]: Business name Identification number Full address

In accordance with the following certificate(s) and or report(s):

[Certificate(s) number(s), report(s) number(s), date(s) of issue]

The following conditions of use and other restrictions apply (¹⁰):

[List or reference to the list of conditions of use and other restrictions]

The following procedures have been followed in order to declare conformity:

[The modules chosen by applicant for the verification of the subsystem]

Identification of the technical file accompanying this declaration

[Reference to the technical file accompanying the ‘EC’ declaration of verification of subsystem in accordance with Article 15(4) of Directive (EU) 2016/797]

Reference to former ‘EC’ declaration of verification (where applicable)

[Yes/No]

Done on:

[date DD/MM/YYYY]

Signature of Applicant

First Name, Surname

ANNEX III

TEMPLATE FOR ‘EC’ DECLARATION OF VERIFICATION FOR SUBSYSTEM INITIALLY PLACED IN SERVICE WITHOUT AN ‘EC’ DECLARATION

‘EC’ declaration of verification of subsystem

‘EC’ declaration identification number [ERADIS ID] (¹¹)

We, Applicant:

[Business name]

[Complete postal address]

Declare under our sole responsibility that for the subsystem to which this declaration refers (¹²):

[Name/short description of the subsystem, unique identification of the subsystem]

The changed part of the subsystem:

[Name/short description of the parts of the subsystem]

has been subject to the relevant verification procedures and complies with the relevant Union law and any relevant national rules:

[Reference to: the Directive(s); TSI(s); Relevant national rules;]

has been assessed by the following conformity assessment bodies:

Notified Body: Business name Registration number Full address	Designated Body: Business name Identification number Full address	Assessment body [Risk assessment]: Business name Identification number Full address

In accordance with the following certificate(s) and or report(s):

[Certificate(s) number(s), report(s) number(s), date(s) of issue]

The unchanged part of the subsystem to which this declaration refers has been brought into use in the railway system and has been maintained in its design operating state since the date of bringing into use in the railway system until the date of the establishing the ‘EC’ declaration of verification.

The following conditions of use and other restrictions apply (¹³):

[List or reference to the list of conditions of use and other restrictions]

The following procedures have been followed in order to declare conformity:

[The modules chosen by applicant for the verification of the subsystem]

Identification of the technical file accompanying this declaration

[Reference to the technical file accompanying the ‘EC’ declaration of verification of subsystem in accordance with Article 15(4) of Directive (EU) 2016/797]

Reference to former ‘EC’ declaration of verification (where applicable)

[Yes/No]

Done on:

[date DD/MM/YYYY]

Signature of Applicant

First Name, Surname

ANNEX IV

TEMPLATE FOR INTERMEDIATE STATEMENT OF VERIFICATION

Intermediate Statement of Verification

Number [unique ISV identification number ensuring traceability of the document] (¹⁴)

Object of Assessment (¹⁵):

[Unique Identification of the subsystem or of the part of the subsystem: identification of whole or of the part of the subsystem, and stages of verification in accordance with point 2.2.3 of Annex IV to Directive (EU) 2016/797]

Applicant, where applicable also Manufacturer and Manufacturing locations:

[Name(s), Address(es)]

Assessment Requirements:

[Reference to: the Directive(s), the TSI(s), the non-application of TSI(s), the relevant National Rules, European specifications, other Acceptable Means of Compliance]

Module(s) applied:

[The modules as chosen by the applicant for the assessment of the subsystem or of a part of the subsystem, and stages of verification]

Assessment/Audit result:

[Including reference to the assessment/audit report]

The following conditions and limits of use apply (¹⁶):

[List or reference to the list of conditions and limits of use]

Annex of ISV (¹⁷) (where applicable)

[Yes/No]

Documentation accompanying this ISV:

[reference to accompanying documents; list or file of documents used for the assessment]

Validity:

[Time and conditions of validity of ISV]

Done on:

[date DD/MM/YYYY]

Notified Body Signature First Name, Surname	[OR]	Designated Body Signature First Name, Surname
Business name	Business name
Registration number	Identification number
Complete postal address	Complete postal address

Page 1[/nn]

Annex to Intermediate Statement of Verification [where applicable]

Number [unique ISV identification number]

Object of Assessment:

[Unique Identification of the subsystem or of the part of the subsystem: identification of whole or of the part of the subsystem, and stages of verification in accordance with point 2.2.3 of Annex IV to Directive (EU) 2016/797]

Done on:

[date DD/MM/YYYY]

Notified Body Signature First Name, Surname	[OR]	Designated Body Signature First Name, Surname
Business name	Business name
Registration number	Identification number
Complete postal address	Complete postal address

Page n/nn

ANNEX V

TEMPLATE FOR CERTIFICATE

[‘EC’]

(¹⁸) Certificate of [conformity/suitability for use/verification]

Number [unique certificate identification number]

(¹⁹)

Object of Assessment (²⁰):

[Unique Identification of the Interoperability Constituent or of the Subsystem]

Applicant, where applicable also Manufacturer and manufacturing locations:

[Name(s), Address(es)]

Assessment Requirements:

[Reference to: the Directive(s), the TSI(s), the relevant National Rules, European specifications, other Acceptable Means of Compliance]

Module(s) applied:

[The module(s) as chosen by the applicant for the assessment of the Interoperability Constituent or of the Subsystem]