I.
<Strong>Module A — Internal production control</Strong>
Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points (a), (b) and (c), and ensures and declares on his sole responsibility that the interoperability constituents concerned satisfy the requirements referred to in Article 15(4) and 15(5) of Directive (EU) 2019/520.
Technical documentation
The manufacturer shall prepare the technical documentation. The documentation shall make it possible to assess the interoperability constituent’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the interoperability constituent. The technical documentation shall, wherever applicable, contain at least the following elements:
a general description of the interoperability constituent,
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the interoperability constituent,
reference to the category of interfaces as set out in Annex I,
a list of the standards and/or other relevant technical specifications, applied in full or in part, and descriptions of the solutions adopted to meet the requirements referred to in Section I,
results of design calculations made, examinations carried out, etc., and
test reports.
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured interoperability constituents with the technical documentation referred to in point (a) and with the requirements of the legislative instruments that apply to them.
‘EC’ declaration of conformity
The manufacturer shall draw up a written ‘EC’ declaration of conformity for an interoperability constituent model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the interoperability constituent has been placed on the market. The ‘EC’ declaration of conformity shall identify the interoperability constituent for which it has been drawn up.
A copy of the ‘EC’ declaration of conformity shall be made available to the relevant authorities upon request.
Authorised representative
The manufacturer’s obligations set out in point (b) may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
II.
<Strong>Module B — EU-type examination</Strong>
1.
EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an interoperability constituent and verifies and attests that the technical design of the interoperability constituent meets the requirements of the legislative instrument that apply to it.
2.
EU-type examination may be carried out in one of the following ways:
examination of a specimen, representative of the production envisaged, of the complete interoperability constituent (production type),
assessment of the adequacy of the technical design of the interoperability constituent through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the interoperability constituent (combination of production type and design type),
assessment of the adequacy of the technical design of the interoperability constituent through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type).
3.
The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
a written declaration that the same application has not been lodged with any other notified body,
the technical documentation, which shall make it possible to assess the interoperability constituent’s conformity with the applicable requirements of the legislative instrument and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the interoperability constituent. The technical documentation shall contain, wherever applicable, at least the following elements:
a general description of the interoperability constituent,
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the interoperability constituent,
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
results of design calculations made, examinations carried out, etc., and
test reports,
the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme,
the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.
4.
The notified body shall:
With regard to the interoperability constituent:
4.1.
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the interoperability constituent;
With regard to the specimen(s):
4.2.
verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards;
4.3.
carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and/or technical specifications, these have been applied correctly;
4.4.
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of the legislative instrument;
4.5.
agree with the manufacturer on a location where the examinations and tests will be carried out.
5.
The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
6.
Where the type meets the requirements of the specific legislative instrument that apply to the interoperability constituent concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured interoperability constituents with the examined type to be evaluated and to allow for in-service control.
Where the type does not satisfy the applicable requirements of the legislative instrument, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
7.
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the interoperability constituent with the essential requirements of the legislative instrument or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.
8.
Each notified body shall inform its notifying authorities concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto, which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
9.
The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the interoperability constituent has been placed on the market.
10.
The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.
V.
<Strong>Suitability for use (interoperability of service)</Strong>
The suitability for use of interoperability constituents is assessed by operation or use of the constituents in service, integrated representatively into the EETS toll system (including test environments) of the toll charger(s) on whose domain the on-board equipment must circulate over a specified operation time. The assessment of suitability for use may include tests predefined in the EETS domain statement or pilots with real users. The toll charger or its authorised representative as well as the EETS provider, the manufacturer or an authorised representative and the notified body to which the EETS provider applied to, shall comply with each step of the suitability-for-use assessment based on measurable criteria or parameters defined in the EETS domain statement in accordance with Annex II.
To carry out such an assessment by means of in-service experience for demonstrating the in-service interoperability of the constituents, the manufacturer, EETS provider or an authorised representative shall either collaborate directly with the toll charger(s) or apply to a notified body, subject to requirements in points (a) and (b). The relevant toll charger may require that tests and/or pilots are carried out by means of the infrastructure provided for by the toll charger, regardless of whether the EETS provider choses to directly collaborate with the toll charger or applies to a notified body.
Where the EETS provider collaborates directly with the toll charger(s) on whose domain the on-board equipment shall circulate:
The manufacturer, EETS provider or an authorised representative shall:
provide for tests or place in service one or more specimens representative of the interoperability constituent(s), as required by the toll charger(s);
monitor the in-service behaviour of the interoperability constituent(s) by a procedure agreed and surveyed by the toll charger(s);
give evidence to the toll charger(s) that the interoperability constituents meet all the interoperability requirements of this (these) Toll Charger(s);
draw up a declaration of suitability for use, conditional to obtaining a suitability for use attestation delivered by the toll charger(s). The declaration of suitability for use covers the assessment by the toll charger(s) of the suitability for use of the EETS interoperability constituents within the EETS environment of this (these) Toll Charger(s);
The toll charger shall:
clearly define the programme for validation by in-service experience
approve the monitoring procedure of the in-service behaviour in its toll domains and carry out specific verifications;
assess the in-service interoperability with its system;
attest the suitability for use on its toll domains in cases where the behaviour of the interoperability constituents is successful.
Where the EETS provider applies to a notified body, the manufacturer, EETS provider or an authorised representative shall:
provide for tests or place in service one or more specimens representative of the interoperability constituent(s), as required and specified by the toll charger(s);
monitor the in-service behaviour of the interoperability constituents using a procedure approved and surveyed by the notified body.
provide evidence to the notified body that the interoperability constituent(s) meet(s) all the interoperability requirements of the toll charger(s), including the results of in-service experience;
draw up the ‘EC’ declaration of suitability-for-use, conditional to obtaining a suitability-for-use certificate delivered by the notified body. The ‘EC’ declaration of suitability for use covers the assessment/judgement by the notified body of the suitability for use of the EETS interoperability constituents, considered within the EETS domain and environment of the selected toll charger(s) and, particularly in cases where interfaces are involved, in relation to the technical specifications, particularly those of a functional nature, which are to be checked;
The notified body shall:
take into consideration the ‘EC’ declaration of conformity to specifications as well as the requirements laid down in the EETS domain statement of the toll charger(s).
organise collaboration with the relevant toll charger(s);
verify the technical documentation and the programme for validation by in-service experience;
approve the monitoring procedure of the in-service behaviour and carry out specific surveillance;
assess in-service interoperability with toll charger systems and operational processes;
issue a suitability-for-use certificate in cases where the behaviour of the interoperability constituents is successful;
issue an explanatory report in case where the behaviour of the interoperability constituent(s)is unsuccessful. The report shall also consider problems that may arise because of non-compliance of a toll charger’s systems and processes with relevant standards and technical specifications. If appropriate, the report shall make recommendations with a view to resolving the problems.
VI.
<Strong>Content and format of the declarations of conformity to specifications and declarations of suitability for use</Strong>
1.
Content of the ‘EC’ Declaration of conformity
The EC declaration of conformity shall state that the fulfilment of requirements set out in Article 15(4), (5) an (6) of Directive (EU) 2019/520 has been demonstrated.
The EC declaration of conformity shall have the model structure set out in point 2 of this Section. It shall contain the elements specified in the relevant modules set out in this Annex and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which market the interoperability constituent is placed or made available.
By drawing up the EC declaration of conformity, the manufacturer shall assume responsibility for the compliance of the interoperability constituent.
2.
Model the EC Declaration of conformity
No … (unique identification of the interoperability constituent):
Name and address of the manufacturer or his authorised representative:
This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
Object of the declaration (identification of interoperability constituent allowing traceability. It may include a photograph, where appropriate):
The object of the declaration described above is in conformity with the relevant Union harmonisation legislation: …
References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:
Where applicable, the notified body … (name, number) … performed …(description of intervention) … and issued the certificate: …
Additional information:
Signed for and on behalf of: …
(place and date of issue):
(name, function) (signature):
‘EC’ declarations of suitability for use and the accompanying documents must be dated and signed.
The declarations shall be written in the same language as the instructions and must contain the following:
references to the relevant legislation;
the name and address of the manufacturer, EETS provider or authorised representative established within the Union (provide the trade name and full address of the authorised representative and the trade name of the manufacturer);
description of interoperability constituent(s) (make, type, version, etc.);
description of the procedure followed in order to declare conformity to specifications or suitability for use;
all the relevant requirements met by the interoperability constituents and, in particular, their conditions of use;
where applicable, name and address of the toll charger(s)/notified body(ies) involved in the procedure followed for the assessment of conformity to specifications or suitability for use;
where appropriate, reference to the technical specifications;
identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of the manufacturer’s authorised representative established within the Union.