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Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,243, 2 ta’
 Awwissu, 2019
Taqsima  B
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L.N. 184 of 2019
PRODUCT SAFETY ACT
(CAP. 427)
Interoperability of the Rail System Regulations, 2019
IN EXERCISE of the powers conferred by articles 38 and 39 of
the Product Safety Act, the Minister for Justice, Culture and Local
Government on the advice of the Director General (Technical
Regulations) has made the following regulations: -
Title, scope and 
commencement.1. (1) The title of these regulat ions is the Interoperability of
the Rail System Regulations, 2019. 
(2) These regulations transpose Directive (EU) 2016/797 and
establish the conditions to be met to achieve interoperability within the
Union rail system in a manner compatible with the provisions of
Directive (EU) 2016/798 in order to define an optimal level oftechnical harmonisation, to make it possible to facilitate, improve and
develop rail transport services within the Union and with third
countries and to contribute to the completion of the single Eur opean
railway area and the progressive a chievement of the internal ma rket.
These conditions concern the design, construction, placing in s ervice,
upgrading, renewal, operation and maintenance of the parts of t hat
system as well as the professional qualifications of, and health and
safety conditions applying to, the staff who contribute to its operation
and maintenance.
(3) These regulations concern the provisions relating to, for
each subsystem, the interoperability constituent s, interfaces and
procedures, and the conditions of overall compatibility of the Unionrail system required in order to achieve its interoperability. 
(4) When a public or private entity submits an official
application for the purpose of building a new railway line which is tobe operated in Malta in accordance  with the applicability of th ese
regulations and which will be rega rded as forming part of the U nion
rail system with a view to its operation by one or more railway
undertakings, but excluding a metro system, a tram, networks th at are
functionally separate from the re st of the Union rail system an d any
other light rail systems, Article 13, Article 14(1) to (8), (11 ) and (12),
Article 15(1) to (9), Article 16(1), Articles 19 to 26, Articles 45, 46and 47, Article 49(1) to (4) and Article 54 of Directive (EU) 2016/797shall apply.
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(5) These regulations shall be deemed to have come into force
on 16 June 2019.
Applicability. 2. (1) The following shall be excluded from the scope of
these regulations:
(a) metros;
(b) trams and light rail vehicles, and infrastructure used
exclusively by those vehicles;
(c) networks that are functionally separate from the rest
of the Union rail system and intended only for the operation of
local, urban or suburban passenger services, as well as
undertakings operating solely on those networks;
(d) privately owned railway infrastructure, including
sidings, used by its owner or by an operator for the purpose oftheir respective freight activities or for the transport of personsfor non-commercial purposes, and vehicles used exclusively on
such infrastructure; 
(e) infrastructure and vehicles reserved for a strictly
local, historical or touristic use;
(f) light rail infrastructure occasionally used by heavy
rail vehicles under the operational conditions of the light rai l
system, where it is necessary for the purposes of connectivity ofthose vehicles only; and
(g) vehicles primarily used on light rail infrastructure but
equipped with some heavy rail  components necessary to enable
transit to be effected on a conf ined and limited section of heavy
rail infrastructure for connectivity purposes only.
(2) In case of tram-trains opera ting in the Union rail system,
where there are no TSIs that apply to those tram-trains, the fo llowing
shall apply:
(a) national rules or other r elevant accessible measures
shall be adopted in order to ensur e that such tram-trains meet the
relevant essential requirements;
(b) national rules may be adopted in order to specify the
authorisation procedure applicable to such tram-trains. The
authority issuing the vehicle au thorisation shall consult the
relevant national safety authority in order to ensure that mixe d
operation of tram-trains and hea vy rail trains meet all essenti al
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requirements as well as relevant common safety targets;
(c) by way of derogation from Article 21 of Directive
(EU) 2016/797, in the case of  cross-border operation, the
relevant competent authorities s hall cooperate with a view to
issuing the vehicle authoris ations. This does not apply to
vehicles excluded from the scope of these regulations in
accordance with r egulation 2(1). 
Definitions. 3. For the purposes of these regulations:
Cap. 427. "the Act" means the Product Safety Act;
"accreditation" means accreditation as defined in point (10)
of Article 2 of Regulation (EC) No 765/2008;
"the Agency" means the European Union Agency for
Railways as established by Regulation (EU) 2016/796;
"applicant" means a natural or legal person requesting an
authorisation, be it a railway undertaking, an infrastructure
manager or any other person or legal entity, such as amanufacturer, an owner or a keeper; for the purpose of Article 15
of Directive (EU) 2016/797, the ‘applicant’ means a contracting
entity or a manufacturer, or its authorised representatives; fo r the
purpose of Article 19 of Direct ive (EU) 2016/797, the ‘applican t’
means a natural or legal person requesting the Agency's decisio n
for the approval of the technical solutions envisaged for theERTMS track-side equipment projects;
"authorised representative" means any natural or legal
person established within the Union who has received a writtenmandate from a manufacturer or a contracting entity to act on
behalf of that manufacturer or c ontracting entity in relation t o
specified tasks; 
"conformity assessment" means the process demonstrating
whether specified requirements relating to a product, process,
service, subsystem, person  or body have been fulfilled;
"conformity assessment body" means a body that has been
notified or designated to b e responsible for conformity
assessment activities, including calibration, testing, certificationand inspection; a conformity asse ssment body is classified as a
‘notified body’ following notification by the TechnicalRegulations Division; a conformi ty assessment body is classifie d
as a ‘designated body’ following designation by a the Technical
Regulations Division;
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"contracting entity" means a public or private entity which
orders the design and/or construction or the renewal or
upgrading of a subsystem;
"design operating state" means  the normal operating mode
and the foreseeable degraded conditions (including wear) withinthe range and the conditions of us e specified in the technical and
maintenance files;
 "ERTMS" means the European Rail Traffic Management
System;
"essential requirements" means all the conditions set out in
Schedule III which must be met by the Union rail system, thesubsystems, and the interopera bility constituents, including
interfaces;
"European specification" means a specification which falls
into one of the following categories:
(a) a common technical specification as defined in
Annex VIII of Dir ective 2014/25/EU; 
(b) a European technical approval as referred to in
Article 60 of Direct ive 2014/25/EU; or
(c) a European standard as defined in point (b) of
Article 2(1) of Regulation (EU) No 1025/2012;
"harmonised standard" mean s a European standard as
defined in point (c) of Articl e 2(1) of Regulation (EU) No 1025 /
2012; 
"infrastructure manager" mea ns an infrastructure manager
as defined in point (2) of Artic le 3 of Directiv e 2012/34/EU;
"interoperability" means the abil ity of a rail system to allow
the safe and uninterrupted movement of trains which accomplishthe required levels of performance;
"interoperability constituen ts" means any elementary
component, group of components, sub-assembly or completeassembly of equipment incorporated or intended to beincorporated into a subsystem, u pon which the interoperability of
the rail system depends directly  or indirectly, including both
tangible objects and intangible objects;
"keeper" means the natural or legal person that, being the
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owner of a vehicle or having the right to use it, exploits the
vehicle as a means of transport and is registered as such in a
vehicle register referred to in Article 47 of Directive (EU) 20 16/
797;
"light rail" means an urban and/or suburban rail transport
system with a crash-worthiness o f C-III or C-IV (in accordance
with EN 15227:2011) and a maximum strength of vehicle of 800
kN (longitudinal compressive for ce in coupling area); light rai l
systems may have their own right  of way or share it with road
traffic and usually do not excha nge vehicles with long-distance
passenger or freight traffic; 
"manufacturer" means any natural or legal person who
manufactures a product in the  form of interoperability
constituents, subsystems or vehicles, or has it designed or
manufactured, and markets it under his name or trademark;
"national accreditation body" means a national
accreditation body as defined in point (11) of Article 2 ofRegulation (EC) No 765/2008;
"national rules" means all binding rules adopted in a
Member State, irrespective of  the body issuing them, which
contain railway safety or techni cal requirements, other than th ose
laid down by Union or internati onal rules which are applicable
within that Member State to railway undertakings, infrastructur e
managers or third parties;
"national safety authority" means a safety authority as
defined in point (7) of Artic le 3 of Directive (EU) 2016/798; 
"network" means the lines, stations, terminals, and all kinds
of fixed equipment needed t o ensure safe and continuous
operation of the Union rail system;
"placing in service" means all the operations by which a
subsystem is put into its operational service;
"placing on the market" means the first making available on
the Union's market of an interop erability constituent, subsyste m
or vehicle ready to function in its design operating state;
"product" means a product obtained through a
manufacturing process, including interoperability constituents
and subsystems;
"railway undertaking" means a railway undertaking as
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defined in point (1) of Articl e 3 of Directive 2012/34/EU, and
any other public or private undertaking, the activity of which is
to provide transport of goods and/or passengers by rail on the
basis that the undertaking is to ensure traction; this also inc ludes
undertakings which provide traction only;
"renewal" means any major substitution work on a
subsystem or part of it which does not change the overall
performance of the subsystem;
"specific case" means any part of the rail system which
needs special provisions in the TSIs, either temporary or
permanent, because of geographical, topographical or urbanenvironment constraints or those affecting compatibility with t he
existing system, in part icular railway lines and networks isola ted
from the rest of the Union, the loading gauge, the track gauge or
space between the tracks and vehi cles strictly intended for loc al,
regional or historical use, as well as vehicles originating fro m or
destined for third countries;
"subsystems" means th e structural or functional parts of the
Union rail system, as set out in Schedule II;
Cap. 510."Technical Regulations Division" means the entity as
established by article 19 of the Malta Competition and Consumer
Affairs Authority Act;
"technical specification for interoperability" or "TSI"
means a specification adopted in accordance with Directive (EU)2016/797 by which each subsystem or part of a subsystem is
covered in order to meet the essential requirements and ensurethe interoperability of t he Union rail system;
"tram-train" means a vehicle designed for combined use on
both a light-rail infrastructure  and a heavy-rail infrastructur e;
"type" means a vehicle type  defining the basic design
characteristics of the vehicle as covered by a type or design
examination certificate describe d in the relevant verification
module; 
"the Union rail system" refers  to the Elements of the Union
Rail System set out in Schedule I;
"upgrading" means any major modification work on a
subsystem or part of it which results in a change in the technicalfile accompanying the ‘EC’ declar ation of verification, if that
technical file exists, and whic h improves the overall performance
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of the subsystem; and 
"vehicle" means a railway vehicle suitable for circulation
on wheels on railway lines, wit h or without traction; a vehicle  is
composed of one or more structur al and functional subsystems.
Non-application 
of TSIs.4. (1) The Technical Regulations Division may allow the
applicant not to apply one or more TSIs or parts of them in the
following cases: 
(a) for a proposed new subsystem or part of it, for the
renewal or upgrading of an existing subsystem or part of it, or  for
any element referred to in Regulation 1(2) which is at an
advanced stage of development or which is the subject of acontract in the course of performance on the date of applicatio n
of the TSI(s) concerned;
(b) where, following an accident  or a natural disaster, the
conditions for the rapid resto ration of the network do not
economically or technically allo w for partial or total applicat ion
of the relevant TSIs, in which case the non-application of theTSIs shall be limited to the period before the restoration of the
network;
(c) for any proposed renewal, extension or upgrading of
an existing subsystem or part of  it, when the application of th e
TSI(s) concerned would compromi se the economic viability of
the project and/or the compatibility of the rail system in Malt a,
for example in relation to the  loading gauge, track gauge, spac e
between tracks or electrification voltage;
(d) for vehicles arriving from or going to third countries
the track gauge of which is different from that of the main rai l
network within the Union;
(e) for a proposed new subsystem or for the proposed
renewal or upgrading of an existing subsystem in Maltese
territory when its rail network is separated or isolated by the  sea
or separated as a result of sp ecial geographical conditions fro m
the rail network of the rest of the Union. 
(2) In the case referred to in s ub-regulation (1)(a), Malta shal l
communicate to the Commission, within one year of entry into fo rce of
each TSI, a list of projects that are taking place within its t erritory and
which, in the view of the Techni cal Regulations Division, are a t an
advanced stage of development. 
(3) In the cases referred to in sub-regulation (1)(a) and (b), the
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Technical Regulations  Division shall communicate to the Commiss ion
its decision not to apply one or more TSIs or parts of them. 
(4) In the cases referred to in sub-regulation (1) (a), (c), (d)  and
(e), the Technical Regulations Division shall submit to the
Commission the request for non-a pplication of the TSIs or parts  o f
them, accompanied by a file cont aining the justification for th e
request, and specifying the alte rnative provisions that the Technical
Regulations Division intends to apply instead of the TSIs. In t he case
referred to in sub-regulation (1 )(e), the Commission shall anal yse the
request and decide whether or not to accept it on the basis of the
completeness and coherence of the information contained in the file. 
In the cases referred to in sub-regulation (1)(c) and (d), the
Commission shall adopt its decision by means of implementing ac ts on
the basis of such analysis. Thos e implementing acts shall be ad opted in
accordance with the examination procedure referred to in Articl e 51(3)
of Directive (EU) 2016/797. In the cases referred to in the thi rd sub-
paragraph of Article 21(6) of Directive (EU) 2016/797, the appl icant
shall submit the file to the Age ncy. The Agency shall consult t he
relevant safety authorities and give its final opinion to the
Commission.
(5) Pending the decision of t he Commission, the Technical
Regulation Division may apply th e alternative provisions referr ed to in
sub-regulation (4)  without delay.
Conditions for 
the placing on the market of 
interoperability 
constituents. 5. (1) The Technical Regulations Division shall take all
necessary steps to ensure that interoperability constituents ar e:
(a) placed on the market only if they enable
interoperability to be achieve d within the Union rail system
while at the same time meeting the essential requirements:
(b) used in their area of use as intended and suitably
installed and maintained. 
Provided that sub-regulation 1(a) and (b) shall not
prevent the placing on the market of those constituents for oth er
applications.
(2) The Technical Regulations Division shall not, in Maltese
territory and on the basis of Directive (EU) 2016/797, prohibit , restrict
or hinder the placing on the mark et of interoperability constit uents for
use in the Union rail system whe re these constituents comply wi th
these Regulations. In particular,  they shall not require checks  w h i c h
have already been carried out as part of the procedure for ‘EC’
declaration of conformity or suit ability for use as provided fo r in
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regulation 7. 
Conformity or 
suitability for 
use.6. The Technical Regulations Division and the Agency shall
consider that an interoperability constituent meets the essenti al
requirements if it complies with the conditions laid down in th e
corresponding TSI or the corresponding European specifications
developed to comply with those conditions. The ‘EC’ declaration  of
conformity or suitability for use shall attest that the interoperabilityconstituents have been subject to the procedures laid down in thecorresponding TSI for assessing conformity or suitability for u se.
 Unsuitability of 
‘EC’
declaration .7. If the Technical Regulations Division finds that the ‘EC’
declaration has been drawn up im properly, it shall ensure that the
interoperability constituent is not placed on the market. In su ch a case,
the manufacturer or his authorised representative shall be requ ired to
restore the interoperability con stituent to a state of conformi ty under
the conditions laid down by the Tec hnical Regulations Division.
Non-compliance of 
interoperability 
constituents with essential 
requirements.8. (1) Where the Technical Regulations Division finds that
an interoperability constituent covered by the ‘EC’ declaration  o f
conformity or suitability for use and placed on the market is, when
used as intended, unlikely to meet the essential requirements, the
Technical Regulations Division shall take all necessary steps t o restrict
its field of applicatio n, prohibit its use, withdraw it from the market or
recall it. The Technical Regulati ons Division shall forthwith i nform
the Commission, the Agency and the other Member States of the
measures taken and give reasons for its decision, stating in pa rticular
whether the failure to conform is due to: 
(a) failure to meet the essential requirements;
(b) incorrect application of European specifications
where application of such specifications is relied upon;
(c) inadequacy of European specifications.
(2) Where the decision referred to in sub-regulation 1 results
from an inadequacy of European specifications, the Technical
Regulations Division, the Commis sion or the Agency, as appropriate,
shall apply one or more of the following measures:
(a) partial or total withdr awal of the specification
concerned from the public ations containing them;
(b) if the relevant specificati on is a harmonised standard,
restriction or withdrawal of th at standard in accordance with
Article 11 of Regulation (EU) No 1025/2012;
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(c) review of the TSI in accordance with Article 6 of
Directive (EU) 2016/797.
(3) Where an interoperability  constituent bearing the ‘EC’
declaration of conformity fail s to comply with the essential
requirements, the Technical Re gulations Division shall take
appropriate measures against any e n t i t y  w h i c h  h a s  d r a w n  u p  t h e
declaration and shall inform the Commission and the other Membe r
States thereof.
Free movement 
of subsystems.9. Without prejudice to the p rovisions of Chapter V of
Directive (EU) 2016/797, the Techni cal Regulations Division sha ll
not, in Maltese territory and on grounds relating to Directive (EU)
2016/797, prohibit, restrict or hinder the construction, placin g in
service and operation of structural subsystems constituting the  r a i l
system which meet the essential requirements. In particular, th e
Technical Regulations Division shall not require checks which h ave
already been carried out:
(a) as part of the procedure leading to the ‘EC’
declaration of verification; or;
(b) in other Member Stats, before or after the entry into
force of Directive (EU) 2016/797, with a view to verifying
compliance with identical r equirements under identical
operational conditions.
Notification of 
national rules.10. (1) Draft national rules and national rules referred to in
paragraph 1 of Article 14 of Directive (EU) 2016/797 shall be
examined by the Agency in accordance with the procedures laid d own
in Articles 25 and 26 of Regulation (EU) 2016/796.
(2) The Commission shal l establish, by means of implementing
acts, the classification of the notified national rules in diff erent groups
with the aim of facilitating cro ss-acceptance in different Memb er
States and the placing on the market of vehicles, includingcompatibility between fixed and mobile equipment. Thoseimplementing acts shall build on the progress achieved by the Agency
in the field of cross-acceptance and shall be adopted in accord ance
with the examination procedure referred to in Article 51(3) of
Directive (EU) 2016/797.
The Agency shall classify, in accordance with the implementing
acts referred to in the first su b-paragraph, the national rules  which are
notified in accordance with this  Article 14 of Directive (EU) 2 016/797.
(3) National rules not notified in  accordance with this Article
14 of Directive (EU) 2016/797 shal l not apply for the purposes of these
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regulations.
Non-compliance 
of subsystems 
with essential 
requirements.11. (1) Technical Regulations Division shall forthwith
inform the Commission of any additional checks requested and se t out
the reasons therefor. The Commission shall consult the interest ed
parties.
(2) Technical Regulations Divis ion shall state whether the
failure to fully comply with these regulations is due to:
(a) non-compliance with the essential requirements or
with a TSI, or incorrect application of a TSI, in which case th e
Commission shall forthwith inf orm the Technical Regulations
Division where the person who drew up the ‘EC’ declaration of
verification in error resides a nd shall request that Technical
Regulation Division to take the appropriate measures;
(b) inadequacy of a TSI, in which case the procedure for
amending the TSI as referred to in Article 6 of Directive (EU)
2016/797 shall apply.
Authorisation 
for the placing in service of 
fixed 
installations.12. (1) The track-side control-command and signalling,
energy and infrastructure subsystems shall be placed in service  only if
they are designed, constructed and installed in such a way as t o meet
the essential requirements, and the relevant authorisation is r eceived in
accordance with sub-re gulations (3) and (4).
(2) The national safety authority shall authorise the placing in
service of the energy, infrastru cture and track-side control-co mmand
and signalling subsystems which are located or operated in the Maltese
territory.
(3) National safety authorities sh all provide detailed guidance
on how to obtain the authorisations referred to in this regulat ion. An
application guidance document describing and explaining the
requirements for those authorisations and listing the documents
required shall be made available to applicants free of charge. The
Agency and the national safety authorities shall cooperate in
disseminating such information. 
(4) The applicant shall submit a request for authorisation of th e
placing in service of f ixed installations to the national safety authority.
The application shall be accompanied by a file which includes
documentary evidence of: 
(a) the declarations of verifi cation referred to in Article
15 of Directive (EU) 2016/797;
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(b) the technical compatibilit y of the subsystems with the
system into which they are being integrated, established on the
basis of the relevant TSIs, national rules and registers;
(c) the safe integration of the subsystems, established on
the basis of the relevant TSIs, national rules, and the commonsafety methods (‘CSMs’) set out in Article 6 of Directive (EU)2016/798;
(d) in the case of track-side control-command and
signalling subsystems involving European Train Control System
(ETCS) and/or Global System  for Mobile Communications -
Railway (GSM-R) equipment, the positive decision of the
Agency issued in accordance with Article 19 of Directive (EU)
2016/797; and, in the case of a change to the draft tender
specifications or to the descrip tion of the envisaged technical
solutions that occurred after the positive decision, the
compliance with the res ult of the procedure referred to in Arti cle
30(2) of Regulation (EU) 2016/796. 
(5) Within one month of receipt of the applicant's request, the
national safety authority shall inform the applicant that the f ile is
complete or ask for relevant s upplementary information, setting  a
reasonable deadline for the provision thereof.
The national safety authority shall verify the completeness,
relevance and consistency of the file, and, in the case of track-side
ERTMS equipment, compliance with the positive decision of the
Agency issued in accordance with Article 19 of Directive (EU) 2016/
797 and, where appropriate, compliance with the result of theprocedure referred to in Artic le 30(2) of Regulation (EU) 2016/ 796.
Following such verification, the  national safety authority shal l issue
the authorisation for placing in service of fixed installations , or inform
the applicant of its negative decision, within a pre-determined ,
reasonable time, and, in any case, within four months of receip t of all
relevant information.
(6) In the event of renewal or upgrading of existing
subsystems, the applicant shall send a file describing the proj ect to the
national safety authority. Within one month of receipt of theapplicant's request, the nationa l safety authority shall inform  t h e
applicant that the file is compl ete or ask for relevant supplem entary
information, setting a reasonable deadline for the provision th ereof.
The national safety authority, i n close cooperation with the Ag ency in
the case of track-side ERTMS projects, shall examine the file a nd shall
decide whether a new authorisation for placing in service is needed, on
the basis of the following criteria: 
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(a) the overall safety level of the subsystem concerned
may be adversely affected by the works envisaged; 
(b) it is required by the relevant TSIs;
(c) it is required by the national implementation plans
established by Malta; or
(d) changes are made to the va lues of the parameters on
the basis of which the authorisation was already granted.
The national safety authority sh all take its decision within a
predetermined, reasonable time, and, in any case, within four m onths
of receipt of all relevant information. 
(7) A decision refusing a request for an authorisation for the
placing in service of fixed inst allations shall be duly substan tiated by
the national safety authority. The applicant may, within one mo nth of
receipt of the negative decision, submit a request that the nat ional
safety authority review its dec ision. The request shall be acco mpanied
by a justification. The national safety authority shall have two months
from the date of receipt of the request for review in which to confirm
or reverse its decision. If the negative decision of a national  safety
authority is confirmed, the applicant may bring an appeal befor e the
appeal body designated by Malta under Article 18(3) of Directive (EU)2016/798.
Designation of 
notifying 
authority. Cap. 510.13. The Technical Regulations Div ision established by article
19 of the Malta Competition and Consumer Affairs Authority Act shall
be the notifying authority for the purposes of articles 27, 28 and 29 of
the Directive (EU) No. 2016/797
Conformity 
assessment bodies. 
S.L. 427.45.14. (1) The procedures for asse ssment and notification of
conformity assessment bodies, a nd the monitoring of notified bodies
shall be those prescribed in the Method for Designating Conform ity
Assessment bodies Regulations. In addition, a conformity assess ment
body shall meet the re quirements laid down in these regulations .
(2) The Technical Regulations Division shall notify the bodies
responsible for carrying out the  procedure for the assessment o f
conformity referred to in sub-re gulation (1), to the Commission  a n d
the other Member States using the electronic notification tool
developed and managed by the Commission and in accordance with the
provisions of Article 37 of Directive (EU) 2016/797.
(3) A conformity assessment body shall be capable of carrying
out all the conformity assessment tasks assigned to it by the r elevant TSI
and in relation to which it has been notified, whether those ta sks are
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carried out by the co nformity assessment body itself or on its behalf and
under its responsibility.
At all times and for each conformity assessment procedure and
each kind or category of product in relation to which it has be en notified,
a conformity assessment body shall have at its disposal:
(a) the necessary personnel with technical knowledge and
sufficient and appropriate exper ience to perform the conformity
assessment tasks;
(b) the relevant descriptions of procedures in accordance
with which conformity assessment is to be carried out, ensuring
the transparency and the ability t o apply those procedures. It shall
have in place appropriate policies and procedures that distinguish
between tasks it carries out as a notified conformity assessmen t
body and other activities;
(c) the proper procedures for t he performance of activities
which take due account of the size of an undertaking, the secto r in
which it operates, its structure , the degree of complexity of t he
product technology in que stion and the mass or serial nature of  the
production process.
It shall have the means necessary to perform in an
appropriate manner the technical and administrative tasksconcerned with the conformity a ssessment activities and shall
have access to all necessar y equipment or facilities.
(4) Conformity assessment bodi es shall participate in, or
ensure that their assessment personnel are informed of, the rel evant
standardisation activities and th e activities of the notified conformity
bodies ‘coordination group estab lished under the relevant Union  Law,
and shall apply as a general guidance the administrative decisions and
documents produced as a result of the work of that group. 
(5) Conformity assessment bodies  that are notif ied for track-
side and/or on-board control-command and signalling subsystemsshall participate in, or shall e nsure that their assessment per sonnel are
informed of, the activities of the ERTMS group referred to in A rticle
29 of Regulation (EU) 2016/796. They shall follow the guideline s
produced as a result of the work of that group. In the event th at they
consider it inappropriate or im possible to apply them, the conf ormity
assessment bodies concerned shall submit their observations fordiscussion to the ERTMS group for the continuous improvement of  the
guidelines. 
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(6) Where a notified body s ubcontracts specific tasks
connected with conformity assessm ent or has recourse to a subsi diary,
it shall ensure that the subcontr actor or the subsidiary meets the
requirements set out in Articles 30 to 32 of Directive (EU) 2016/797
and shall inform the Technical Regulations Division accordingly .
(7) Notified bodies shall take full responsibility for the tasks
performed by subcontractors or subsidiaries wherever these areestablished. Activities of notified bodies may be subcontracted  o r
carried out by a subsidiary only with the agreement of the clie nt.
(8) Notified bodies shall keep at the disposal of the Technical
Regulations Division the relevant documents concerning the
assessment of the qualifications of the subcontractor or the su bsidiary
and the work carried out by the m under the relevant TSI.
(9) A conformity assessment body, its top-level management
and the personnel responsible for carrying out the conformity
assessment tasks shall not be the designer, manufacturer, suppl ier,
installer, purchaser, owner, user or maintainer of the products  w h i c h
they assess, or the authorised representative of any of those p arties. This
shall not preclude the use of a ssessed products that are necessary for the
operations of the conformity assessment body or the use of such
products for personal purpose. 
(10) A conformity assessment body, its top-level management
and the personnel responsible for carrying out the conformityassessment tasks shall not be directly involved in the design,
manufacturer or construction, ma rketing, installation, use or
maintenance of those products, or  represent the parties engaged  in those
activities. They shall not engage in any activity that may conf lict with
their independence of judgment or integrity in relation to conf ormity
assessment activities for which they are notified. This prohibi tion shall
apply, in particular, to consultancy services.
(11) Conformity assessmen t bodies shall ensure that the activiti es
of their subsidiaries or subcont ractors do not affect the confi dentiality,
objectivity or impartiality of the ir conformity assessment activities.
Presumption of 
conformity of a conformity 
assessment 
body.15. Where a conformity asse ssment body demonstrates its
conformity with the criteria lai d down in the relevant harmonis ed
standards or parts thereof, the references of which have been p ublished
in the Official Journal of the European Union, it shall be pres umed to
comply with the requirements set out in Articles 30 to 32 of Directive
(EU) 2016/797, in so far as the ap plicable harmonised standards cover
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those requirements.
Accredited in-
house bodies.16. (1) Applicants may use an accredited in-house body to
carry out conformity assessment ac tivities for the purpose of
implementing the procedures set out in modules A1, A2, C1 or C2  laid
down in Annex II to Decision No 768/2008/EC and modules CA1 and
CA2 laid down in Annex I to Decision 2010/713/EU. That body sha ll
constitute a separate and distin ct part of the applicant concerned and
shall not participate in the design, production, supply, instal lation, use
or maintenance of the product it assesses.
(2) An accredited in-house body shall meet the following
requirements: 
(a) it shall be accredited in accordance with Regulation
(EC) 765/2008;
(b) the body and its personnel shall, within the
undertaking of which they form a part, be organisationally
identifiable and have reporti ng methods which ensure their
impartiality, and shall demonstrate it to the competent nationa l
accreditation body;
(c) neither the body nor its personnel shall be responsible
for the design, manufacture, supply, installation, operation or
maintenance of the products they assess, nor shall they engage in
any activity that might conflict with their independence ofjudgement or integrity in relation to their assessment activities;
(d)  the body shall supply its services exclusively to the
undertaking of which it forms a part. 
(3) An accredited in-house body shall not be notified to the
Member States or the Commissi on, but information concerning its
accreditation shall be given by the undertaking of which it for ms a part
or by the national accreditati on body to the Technical Regulati ons
Division at request.
Changes to 
notifications.17. (1) Where the Technical Regulations Division has
ascertained or has been informe d that a notified body no longer  meets
the requirements laid down in Articles 30 to 32 of Directive (E U)
2016/797, or that it is failing to fulfil its obligations, the Technical
Regulations Division shall restri ct, suspend or withdraw notifi cation as
appropriate, depending on the seriousness of the failure to mee t those
requirements or fulfil those oblig ations. It shall immediately inform
the Commission and the other Me mber States accordingly
(2) In the event of restriction, suspension or withdrawal of
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notification, or where the notified body has ceased its activit y, the
Technical Regulations Division shall take appropriate steps to ensure
that the files of that body are either processed by another not ified body
or kept available for the respons ible notifying and market surv eillance
authorities at their request.
Challenges to 
the competence of notified 
bodies.18. The Technical Regulations Division shall provide the
Commission, on request, with all information relating to the ba sis for
the notification or the maintenan ce of the competence of the bo dy
concerned.
Operational obligations of 
notified bodies.19. (1) Notified bodies shall carry out conformity
assessments in accordance with the conformity assessment procedures
provided for in the relevant TSI.
(2) Conformity assessments shall be carried out in a
proportionate manner, avoiding unnecessary burdens for economic
operators. Notified bodies, when performing their activities, s hall take
due account of the size of an undertaking, the sector in which it
operates, its structure, the degree of complexity of the produc t
technology in question and the mass or serial nature of the production
process.
In so doing, they shall nevertheless operate with the aim of
assessing the compliance of the product with these regulations.
(3) Where a notified body finds that requirements laid down in
the relevant TSI or corresponding harmonised standards or techn ical
specifications have not been met by a manufacturer, it shall re quire
that manufacturer to take appropriate corrective measures and shall not
issue a conformity certificate.
(4) Where, in the course of the monitoring of conformity
following the issue of a cer tificate, a notified body finds tha t a product
no longer complies with the rele vant TSI or corresponding harmonised
standards or technical specifications, it shall require the manufacturerto take appropriate corrective m easures and shall suspend or wi thdraw
the certificate if necessary.
(5) Where corrective measures are not taken or do not have the
required effect, the notified body  shall restrict, suspend or w ithdraw
any certificates, as appropriate.
Obligation of 
notified bodies 
to provide information.20. (1) Notified bodies shall inf orm the notifying authority
of the following:
(a) any refusal, res triction, suspension or withdrawal of a
certificate;
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(b) any circumstances affecting the scope of, and
conditions for, notification;
(c) any request for information which they have received
from market surveillance authorities regarding conformity
assessment activities;
(d) on request, conformity  assessment activities
performed within the scope of their notification and any otheractivity performed, including cross-border activities and
subcontracting. 
The competent national safety authorities shall also be
informed of any refusal, restriction, suspension or withdrawal ofa certificate under sub-regulation (1)(a).
(2) Notified bodies shall provi de the other bodies notified
under Directive (EU) 2016/797 carrying out similar conformityassessment activities covering the same products with relevant
information on issues relating to negative and, on request, positive
conformity assessment results.
(3) Notified bodies shall provide the Agency with ‘EC’
certificates of verification of subsystems, ‘EC’ certificates o f
conformity of interoperability c onstituents and ‘EC’ certificat es of
suitability of use of interoperability constituents.
Coordination of 
notified bodies.21. Bodies notified by the Technical  Regulations Division shall
participate in the work of sec toral groups of notified bodies a s
established by the Commission under Directive (EU) 2016/797,
directly or by means of designate d representatives. The Agency shall
support the activities of notified bodies in accordance with Article 24
of Regulation (EU) 2016/796.
Other 
transitional 
provisions.
S.L. 427.31.22. (1) Schedules IV , V , VII and IX to the Interoperability of
the Rail System Regulations shall apply unt il the date of appli cation of
the corresponding implementing acts referred to in Article 7(5) ,
Article 9(4), Article 14(10) and Article 15(9) of Directive (EU ) 2016/
797. 
(2) Directive 2008/57/EC shall continue to apply in relation to
ERTMS track-side projects which are to be placed before 16 June
2019. 
(3) Projects which have complet ed the tendering or contracting
phase prior to 16 June 2019 are not subject to the pre-authorisation bythe Agency referred to in Article 19 of Directive (EU) 2016/797. 
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(4) Until 16 June 2031 options included in contracts which
were signed before 15 June 2016 shall not be subject to the pre-
authorisation by the Agency referred to in Article 19 of Direct ive (EU)
2016/797, even if they are exercised after 15 June 2016. 
(5) Before authorising the placing in service of any ERTMS
track-side equipment which was not subject to the pre- authoris ation
by the Agency referred to in Article 19 of Directive (EU) 2016/ 797,
national safety authorities shall cooperate with the Agency in order to
ensure that the technical solutions are fully interoperable, in
accordance with Articles 30(3) a nd 31(2) of Regulation (EU) 201 6/
796.
Penalties and 
Proceedings Cap. 427.23. The penalties and proceedings  applicable for infringement
of any of the provisions of thes e regulations shall be those pr ovided for
in Part IV of the Product Safety Act.
Repeal of S.L. 427.31. 24. The Interoperability of the Rail System Regulations shall
be repealed with effect from 16 June 2020.
SCHEDULE I
ELEMENTS OF THE UNION RAIL SYSTEM
1. Network
For the purposes of these regulations, the Union's network shal l
include the following elements: 
(a) specially built high-speed lines equipped for speeds
generally equal to or greater than 250 km/h;
(b) specially upgraded high-speed lines equipped for speeds of
the order of 200 km/h;
(c) specially upgraded high-sp eed lines which have special
features as a result of t opographical, relief or town-
planning constraints, to which the speed must be adapted in
each case. This category includes interconnecting lines
between high-speed and conv entional networks, lines
through stations, accesses to  terminals, depots, etc.
travelled at conventional speed by ‘high-speed’ rollingstock;
(d) conventional lines intended for passenger services;
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(e) conventional lines intended fo r mixed traffic (passengers
and freight);
(f) conventional lines intend ed for freight services;
(g) passenger hubs;
(h) freight hubs, including i ntermodal terminals;
(i) lines connecting the above-mentioned elements.
This network includes traffic management, tracking and
navigation systems, technical ins tallations for data processing
and telecommunications intended for long-distance passenger
services and freight services on the networ k in order to guaran tee
the safe and harmonious operation of the network and efficient
traffic management.
2. Vehicles
For the purposes of these regul ations, Union vehicles shall
comprise all vehicles likely to travel on all or part of the Un ion's
network:
— locomotives and passenger rolling stock, including thermal
or electric traction units, self-propelling thermal or electricpassenger trains, and passenger coaches;
— freight wagons, including low- deck vehicles designed for
the entire network and vehicles designed to carry lorries;
— special vehicles, suc h as on-track machines
This list of vehicles shall include those which are specially
designed to operate on the different types of high-speed linesdescribed in point 1. 
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SCHEDULE II
SUBSYSTEMS
1. List of subsystems
For the purposes of these regulations, the system constituting the
Union rail system may be broken down into the following
subsystems, either:
(a) structural areas: 
— infrastructure,
— energy,
— track-side control-command and signalling,— on-board control-command and signalling,
— rolling stock; or 
(b) functional areas: 
— operation and traffic management, — maintenance, 
— telematics applications for passenger and
freight services. 
2. Description of the subsystems
For each subsystem or part of a  subsystem, the list of constitu ents
and aspects relating to interop erability is proposed by the Age ncy
at the time of drawing up the relevant draft TSI. Without
prejudging the choice of aspects and constituents relating to
interoperability or the order in which they will be made subjec t to
TSIs, the subsystems include the following:
2.1. Infrastructure
The track, points, level crossings , engineering structures (bri dges,
tunnels, etc.), rail-related el ements of stations (including
entrances, platforms, zones of access, service venues, toilets and
information systems, as well as their accessibility features fo r
persons with disabilities and persons with reduced mobility),
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safety and protective equipment.
2.2. Energy
The electrification system, in cluding overhead lines and the
trackside electricity consum ption measuring and charging
system.
2.3. Trackside control-command and signalling
All the trackside equipment required to ensure safety and to
command and control movements of  trains authorised to travel on
the network.
2.4. On-board control-command and signalling
All the on-board equipment required to ensure safety and to
command and control movements of  trains authorised to travel on
the network.
2.5. Operation and traffic management
The procedures and related equipment permitting coherent
operation of the various structural subsystems, during both
normal and degraded operation, including in particular traincomposition and train driving, traffic planning and management.
The professional qualifications which may be required for
carrying out any type of railway service.
2.6. Telematics applications
In accordance with Schedule I, this subsystem comprises two
elements:
(a) applications for passenger services, including systems
which provide passengers with information before andduring the journey, reservation and payment systems,luggage management and management of connections
between trains and with ot her modes of transport;
(b) applications for freight ser vices, including information
systems (real-time monitoring of freight and trains),marshalling and allocation systems, reservation, payment
and invoicing systems, management of connections withother modes of transport a nd production of electronic
accompanying documents.
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2.7. Rolling stock
Structural body, command and control system for all train
equipment, electric current co llection devices, traction and
energy conversion units, on-board equipment for electricity
consumption measuring and ch arging, braking, coupling and
running gear (bogies, axles, etc.) and suspension, doors, man/
machine interfaces (driver, on-board staff and passengers,
including accessibility features for persons with disabilities and
persons with reduced mobility), passive or active safety device s
and requisites for the health of passengers and on-board staff.
2.8. Maintenance
The procedures, associated e quipment, logistics centres for
maintenance work and reserves providing the mandatorycorrective and preventive maintenance to ensure the
interoperability of the Union rail system and guarantee the
performance required.
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SCHEDULE III
ESSENTIAL REQUIREMENTS
1. General requirements
1.1. Safety1.1.1.The design, construction or  assembly, maintenance and
monitoring of safety-critical components, and more particularly
of the components involved in train movements, must be such asto guarantee safety at the level corresponding to the aims laid
down for the network, including those for specific degraded
situations.
1.1.2.The parameters involved in the wheel/rail contact must me et the
stability requirements needed in order to guarantee safemovement at the maximum authorised speed. The parameters ofbrake equipment must guarantee that it is possible to stop with in
a given brake distance at the maximum authorised speed.
1.1.3.The components used must with stand any normal or exceptio nal
stresses that have been specified during their period in servic e.
The safety repercussions of any accidental failures must belimited by appropriate means.
1.1.4.The design of fixed installations and rolling stock and the choice
of the materials used must be ai med at limiting the generation,
propagation and effects of fire and smoke in the event of a fir e.
1.1.5.Any devices intended to be handled by users must be desig ned in
such a way as not to impair the safe operation of the devices o r
the health and safety of users if used in a foreseeable manner,
albeit not in accordance w ith the posted instructions.
1.2. Reliability and availability
The monitoring and maintenance of fixed or movable
components that are involved in train movements must beorganised, carried out and quantified in such a manner as tomaintain their operation under the intended conditions.
1.3. Health
1.3.1.Materials likely, by virtue of the way they are used, to constitute
a health hazard to those having access to them must not be used
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in trains and railway infrastructures.
1.3.2.Those materials must be sel ected, deployed and used in su ch a
way as to restrict the emission of harmful and dangerous fumes or
gases, particularly in the event of fire.
1.4. Environmental protection
1.4.1.The environmental impact of establishment and operation o f the
rail system must be assessed and taken into account at the design
stage of the system in accordance with Union law.
1.4.2.The materials used in the tr ains and infrastructures must prevent
the emission of fumes or gases which are harmful and dangerous
to the environment, particularly in the event of fire.
1.4.3.The rolling stock and energy-supply systems must be desig ned
and manufactured in such a way  as to be electromagnetically
compatible with the installations, equipment and public or priv ate
networks with which t hey might interfere.
1.4.4.The design and operation of rail system must not lead to an
inadmissible level of noise generated by it:
— in areas close to railway infra structure, as defined in point
(3) of Article 3 of Dir ective 2012/34/EU, and 
— in the driver's cab.
1.4.5.Operation of the rail system must not give rise to an inadmissible
level of ground vibrations for t he activities and areas close t o the
infrastructure and in a normal state of maintenance.
1.5. Technical compatibility
The technical characteristics of  the infrastructure and fixed
installations must be compatible with each other and with those
of the trains to be used on the rail system. This requirement
includes the safe integration of  the vehicle's subsystem with the
infrastructure.
If compliance with these char acteristics proves difficult on
certain sections of the network, temporary solutions, which
ensure compatibility in the future, may be implemented.
1.6. Accessibility
1.6.1.The ‘infrastructure’ and ‘r olling stock’ subsystems must be
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accessible to persons with disabilities and persons with reduce d
mobility in order to ensure access on an equal basis with other s
by way of the prevention or removal of barriers, and by way of
other appropriate measures. Th is shall include the design,
construction, renewal, upgrade, m aintenance and operation of th e
relevant parts of the subsystems to which the public has access .
1.6.2.The ‘operations’ and ‘telemat ics applications for passeng ers’
subsystems must provide for the  necessary functionality require d
to facilitate access for persons w ith disabilities and persons with
reduced mobility on an equal basis with others by way of theprevention or removal of barriers, and by way of otherappropriate measures.
2. Requirements specific to each subsystem
2.1. Infrastructure2.1.1.Safety
Appropriate steps must be taken to prevent access to, or
undesirable intrusions into, installations.
Steps must be taken to limit th e dangers to which persons are
exposed, particularly when t rains pass through stations.
Infrastructure to which the public has access must be designed
and made in such a way as to limit any human safety hazards
(stability, fire, access, evacu ation, platforms, etc.). Appropr iate
provisions must be laid down to t ake account of the particular
safety conditions in very long tunnels and viaducts.
2.1.2.Accessibility
Infrastructure subsystems to wh ich the public has access must b e
accessible for persons with disabilities and persons with reduc ed
mobility in accordance with point 1.6.
2.2. Energy
2.2.1.Safety
Operation of the energy-supply systems must not impair the
safety either of trains or of persons (users, operating staff, track-
side dwellers and t hird parties).
2.2.2.Environmental protection
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The functioning of the electri cal or thermal energy-supply
systems must not interfere with the environment beyond the
specified limits.
2.2.3.Technical compatibility
The electricity/thermal en ergy-supply systems used must:
— enable trains to achieve the specified performance levels,
— in the case of electricity energy-supply systems, be
compatible with the collecti on devices fitted to the trains.
2.3. Control-command and signalling2.3.1.Safety
The control-command and signal ling installations  and procedures
u s e d  m u s t  e n a b l e  t r a i n s  t o  t r a v e l  w i t h  a  l e v e l  o f  s a f e t y  w h i c h
corresponds to the objectives set for the network. The control-
command and signalling systems must continue to provide forsafe passage of trains permitted to run under degraded conditio ns.
2.3.2.Technical compatibility
All new infrastructure and all new rolling stock manufactured o r
developed after adoption of c ompatible control-command and
signalling systems must be tailored to the use of those systems .
The control-command and signalling equipment installed in the
train drivers' cabs must permit normal operation, under the
specified conditions, thr oughout the rail system.
2.4. Rolling stock
2.4.1.Safety
The rolling-stock structures and those of the links between
vehicles must be designed in such a way as to protect the
passenger and driving compartments in the event of collision or
derailment.
The electrical equipment must not impair the safety and
functioning of the control-command and signalling installations .
The braking techniques and the stresses exerted must be
compatible with the design of th e tracks, engineering structure s
and signalling systems.
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Steps must be taken to prevent access to electrically-live
constituents in order not to endanger the safety of persons.
In the event of danger, devices must enable passengers to infor m
the driver and accompanying staff to contact them.
The safety of passengers boarding and alighting from trains mus t
be ensured. The access doors must incorporate an opening and
closing system which guara ntees passenger safety.
Emergency exits must be provided and indicated.
Appropriate provisions must be laid down to take account of the
particular safety conditions in very long tunnels.
An emergency lighting system hav ing a sufficient intensity and
duration is an absolute requirement on board trains.
Trains must be equipped with a  public address system which
provides a means of communicat ion to the public from on-board
staff.
Passengers must be given easily understandable and
comprehensive information about rules applicable to them both
in railway stations and in trains.
2.4.2.Reliability and availability
The design of the vital equipmen t and the running, traction and
braking equipment as well as t he control- command system must,
in a specific degraded situation, be such as to enable the trai n to
continue without adverse consequences for the equipmentremaining in service.
2.4.3.Technical compatibility
The electrical equipment must be compatible with the operation
of the control-command and signalling installations.
In the case of electri c traction, the characteristics of the cu rrent-
collection devices must be such as to enable  trains to travel u nder
the energy-supply systems  for the rail system.
The characteristics of the rollin g stock must be such as to all ow it
to travel on any line on which it is expected to operate, takin g
account of relevant climatic conditions.
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2.4.4.Controls
Trains must be equipped with a recording device. The data
collected by that device and the processing of the information
must be harmonised.
2.4.5.Accessibility
Rolling-stock subsystems to whic h the public has access must be
accessible for persons with disabilities and persons with reduc ed
mobility in accordance with point 1.6.
2.5. Maintenance
2.5.1.Health and safety
The technical installations and th e procedures used in the cent res
must ensure the safe operation of the subsystem and not
constitute a danger to health and safety.
2.5.2.Environmental protection
The technical installations a nd the procedures used in the
maintenance centres must not exceed the permissible levels ofnuisance with regard to the  surrounding environment.
2.5.3.Technical compatibility
The maintenance installations for  rolling stock must be such as  to
enable safety, health and comfor t operations to be carried out on
all stock for which they have been designed.
2.6. Operation and traffic management
2.6.1.Safety
Alignment of the network operati ng rules and the qualifications
of drivers and on-board staff and of the staff in the control c entres
must be such as to ensure safe operation, bearing in mind the
different requirements of cross -border and domestic services.
The maintenance operations and intervals, the training and
qualifications of the maintenanc e and control centre staff and the
quality assurance syst em set up by the opera tors concerned in t he
control and maintenance centres must be such as to ensure a hig h
level of safety.
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2.6.2.Reliability and availability
The maintenance operations and periods, the training and
qualifications of the maintenanc e and control centre staff and the
quality assurance system set up by the operators concerned in t he
control and maintenance centres must be such as to ensure a hig h
level of system reliab ility and availability.
2.6.3.Technical compatibility
Alignment of the network opera ting rules and the qualifications
of drivers, on-board staff and tr affic managers must be such as  to
ensure operating efficiency on the rail system, bearing in mind
the different requirements of cross-border and domestic services.
2.6.4.Accessibility
Appropriate steps must be taken to ensure that operating rules
provide for the necessary functionality required to ensure
accessibility for persons with disabilities and persons with
reduced mobility.
2.7. Telematics applications  for freight and passengers
2.7.1.Technical compatibility
The essential requirements for te lematics applications guarante e
a minimum quality of service for passengers and carriers ofgoods, particularly in terms of  technical compatibility.
Steps must be taken to ensure:
— that the databases, software and data communication
protocols are developed in  a manner allowing maximum
data interchange between different applications and
operators, excluding confidential commercial data,
— easy access to the information for users.
2.7.2. Reliability and availability
The methods of use, management, updating and maintenance of
these databases, software and da ta communication protocols must
guarantee the efficiency of the se systems and the quality of th e
service.
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2.7.3. Health
The interfaces between these s ystems and users must comply
with the minimum rules on ergonomics and health protection.
2.7.4. Safety
Suitable levels of integrity and dependability must be provided
for the storage or transmission of safety-related information.
2.7.5. Accessibility
Appropriate steps must be taken to ensure that telematics
applications for passenger subsystems provide for the necessary
functionality required to ensure accessibility for persons with
disabilities and persons w ith reduced mobility.
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SCHEDULE IV
‘EC’ VERIFICATION PROCEDURE FOR SUBSYSTEMS
1. GENERAL PRINCIPLES
‘"EC" verification’ means a pr ocedure carried out by the
applicant within the meaning of  Article 15 to Directive (EU)
2016/797 to demonstrate that the requirements of the relevant
Union law and any relevant national rules relating to a subsyst em
have been fulfilled and the subsystem may be authorised to be
placed in service.
2. CERTIFICATE OF VERIFICATION ISSUED BY A NOTIFIED
BODY
2.1. Introduction
For the purpose of these regul ations, the verification by refer ence
to TSIs is the procedure whereby a notified body checks andcertifies that the subsystem complies with the relevant technic al
specifications for interoperability (TSI).
This is without prejudice to the obligations of the applicant t o
comply with the other applicable legal acts of the Union and an y
verifications by the assessment  bodies required by the other ru les.
2.2. Intermediate stateme nt of verification (ISV)
2.2.1 Principles 
At the request of the applican t the verifications may be done f or
parts of a subsystem or may be li mited to certain stages of the
verification procedure. In these cases, the results of verifica tion
may be documented in an ‘interme diate statement of verification ’
(ISV) issued by the notified body chosen by the applicant. The
ISV must provide reference to the TSIs with which theconformity has been assessed.
2.2.2 Parts of the subsystem
The applicant may apply for an ISV for any part into which he
decides to split the s ubsystem. Each part s hall be checked at e ach
stage as set out in point 2.2.3.
2.2.3 Stages of the verification procedure
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The subsystem, or certain par ts of the subsystem, shall be
checked at each of the following stages:
(a) overall design;
(b) production: construction, inc luding, in particular, civil-
engineering activities, manuf acturing, constituent assembly
and overall adjustment;
(c) final testing.
The applicant may apply for an ISV for the design stage
(including the type tests) and for the production stage for the
whole subsystem or for any part i nto which the applicant decide d
to split it (see point 2.2.2).
2.3. Certificate of verification
2.3.1.The notified bodies responsible  for the verification asse ss the
design, production and final testing of the subsystem and draw up
the certificate of verification intended for the applicant who in
turn draws up the ‘EC’ declara tion of verification. The certifi cate
of verification must provide reference to the TSIs with which the
conformity has been assessed.
Where a subsystem has not been as sessed for its conformity with
all relevant TSI(s) (e.g. in the case of a derogation, partialapplication of TSIs for upgrade or renewal, transitional period  in
a TSI or specific case), the cert ificate of verification shall give
the precise reference to the TSI(s) or their parts whoseconformity has not been examin ed by the notified body during
the verification procedure.
2.3.2.Where ISV have been issued, the notified body responsible  for
the verification of the subsystem takes these ISV into account,
and, before issuing its certificate of verification:
(a) verifies that the ISV cover correctly the relevant
requirements of the TSI(s);
(b) checks all aspects that  are not covered by the ISV; and
(c) checks the final testing of the subsystem as a whole.
2.3.3.In the case of a modification to a subsystem already cove red by a
certificate of verification, th e notified body shall perform on ly
those examinations and tests that are relevant and necessary, i .e.
assessment shall relate only to the parts of the subsystem that  are
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changed and their interfaces to the unchanged parts of the
subsystem.
2.3.4Each notified body involved in the verification of a subsystem
shall draw up a file in accordance with Article 15(4) of Direct ive
(EU) 2016/797 covering the scope of its activities.
2.4. Technical file accompanying the ‘EC’ declaration of verification.
The technical file accompanyi ng the ‘EC’ declaration of
verification shall be assembled by the applicant and must conta in
the following:
(a) technical characteristics l inked to the design including
general and detailed drawings  with respect to execution,
electrical and hydrau lic diagrams, control-circuit diagrams,
description of data-processing and automatic systems to the
level of detail sufficient for documenting the verification of
conformity carried out, documentation on operation and
maintenance, etc., relevant for the subsystem concerned;
(b) a list of interoperability constituents, referred to in poin t (d)
of Article 4(3) of Directive (EU) 2016/797, incorporatedinto the subsystem;
(c) the files referred to in Article 15(4) of Directive (EU) 201 6/
797, compiled by each of the notified bodies involved inthe verification of the subsys tem, which shall include:
— copies of the ‘EC’ declarations of verification and,
where applicable, ‘EC’ declarations of suitability foruse established for inte roperability constituents
referred to in point (d) of Article 4(3) of Directive
(EU) 2016/797 and accompan ied, where appropriate,
by the corresponding calculation notes and a copy of
the records of the tests and examinations carried outby the notified bodies on the basis of the common
technical specifications,
— where available, the ISV that accompany the
certificate of verification, including the result ofverification by the notified body of the ISV validity,
— the certificate of veri fication, accompanied by
corresponding calculation notes and signed by the
notified body responsible for t he verification, stating
that the subsystem complies with the requirements of
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the relevant TSI(s) and mentioning any reservations
recorded during performance of the activities and not
withdrawn; the certificate of verification should alsobe accompanied by the inspection and audit reports
drawn up by the same body in connection with its
task, as specified in points 2.5.2 and 2.5.3;
(d) certificates of verification issued in accordance with other
legal acts of the Union;
(e) when verification of safe integration is required pursuant t o
point (c) of regulation 12(4) and point (c) of Article 21(3)of Directive (EU) 2016/797, the relevant technical file shallinclude the assessors' report(s) on the CSMs on risk
assessment referred to in Article 6(3 ) of Directive 2004/49/
EC. 
2.5. Surveillance by notified bodies.
2.5.1.The notified body responsible for checking production must have
permanent access to building sites, production workshops,
storage areas and, where appropriate, prefabrication or testing
facilities and, more generally, to  all premises which it consid ers
necessary for its task. The notified body must receive from the
applicant all the documents needed for that purpose and, in
particular, the implementation plans and technica l documentatio n
concerning the subsystem.
2.5.2.The notified body responsible f or checking implementation  must
periodically carry out audits in order to confirm compliance wi th
the relevant TSI(s). It must provide those responsible for
implementation with an audit repor t. Its presence may be requir ed
at certain stages of the building operations.
2.5.3.In addition, the notified body may pay unexpected visits to the
work-site or to the production workshops. At the time of such
visits the notified body may conduct complete or partial audits . It
must provide those responsible for implementation with an
inspection report and, if appropriate, an audit report.
2.5.4.The notified body shall be able to monitor a subsystem on  which
an interoperability constituent is mounted in order to assess,where required by the corresponding TSI, its suitability for us e in
its intended railway environment.
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2.6. Submission
A copy of the technical file accompanying the ‘EC’ declaration
of verification must be kept by the applicant throughout the
service life of the subsystem. It must be sent to any Member St ate
or the Agency, upon request.
The documentation submitted for an application for an
authorisation for placing in service shall be submitted to the
authority where the authorisation is sought. The national safet y
authority or the Agency may request that part(s) of the documentssubmitted together with the aut horisation is/are translated int o its
own language.
2.7. Publication
Each notified body must periodically publish relevant
information concerning:
(a) requests for veri fication and ISV received;
(b) request for assessment of conf ormity and suitability for use
of ICs;
(c) ISV issued or refused;
(d) certificates of verificati on and ‘EC’ certificates for
suitability for use issued or refused;
(e) certificates of verifi cation issued or refused.
2.8. Language
The files and correspondence relating to the ‘EC’ verification
procedure must be written in Maltese or English.
3. CERTIFICATE OF VERIFICATION ISSUED BY A
DESIGNATED BODY
3.1. Introduction
In the case where national rules apply, the verification shall
include a procedure whereby the body designated pursuant to
Article 15(8) of Directive (E U) 2016/797, (the designated body)
checks and certifies that the subsystem complies with the natio nal
rules notified in accordance wit h Article 14 of Directive (EU)
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2016/797 for each Member State in which the subsystem is
intended to be authorise d to be placed in service.
3.2. Certificate of verification
The designated body draws up the certificate of verification
intended for the applicant.
The certificate shall contain a precise reference to the nation al
rule(s) whose conformity has been examined by the designatedbody in the verification process.
In the case of national rules re lated to the subs ystems composing
a vehicle, the designated body sh all divide the certificate int o two
parts, one part including the references to those national rule s
strictly related to the technica l compatibility between the veh icle
and the network concerned, and the other part for all other
national rules. 
3.3. File
The file compiled by the designated body and accompanying the
certificate of verification in t he case of national rules must be
included in the technical file accompanying the ‘EC’ declaratio n
of verification referred to in point 2.4 and shall contain the
technical data relevant for the assessment of the conformity of  the
subsystem with those national rules.
3.4. Language
The files and correspondence relating to the ‘EC’ verification
procedure must be written in Maltese or English.
4. VERIFICATION OF PARTS OF SUBSYSTEMS IN
ACCORDANCE WITH ARTICLE 15(7) OF DIRECTIVE (EU)
2016/797
If a certificate of verification is to be issued for certain pa rts of a
subsystem, provisions for this Schedule shall apply mutatis
mutandis  for those parts.
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Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta
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