Conformity Assessment - European Rail System

Conformity Assessment until February 1, 2022

The scope of application of the Interoperability Directive 2008/57/EC is defined in the Czech Republic by Act No. 266/1994 Coll. on Railways and Government Regulation No. 133/2005 Coll., which also implements Commission Implementing Regulation (EU) No. 402/2013 on a common safety method for risk evaluation and assessment and repealing Regulation (EC) No. 352/2009. Interoperability Directive No. 2008/57/EC was repealed on October 30, 2020, and replaced by Directive (EU) 2016/797. Government Regulation No. 133/2005 Coll. establishes technical requirements for components and subsystems of the European rail system and regulates the conditions for authorizing a legal entity to perform conformity assessment activities for specified products.

Amendment to the Railways Act by Act No. 426/2021 Coll. (technical transposition of Directive (EU) 2016/797); for effective date, see Article V (technical transposition of Directive (EU) 2016/797; notification should be carried out in accordance with Act
No. 90/2016 Coll., as amended by Act No. 87/2023 Coll. (the amendment by Act No. 87/2023 Coll. shall apply from April 6, 2023).

Interoperability constituents pursuant to Government Regulation No. 133/2005 Coll. and Act No. 22/1997 Coll. are defined products. The use of an interoperability constituent is defined in Section 5 of Government Regulation No. 133/2005 Coll. Requirements for interoperability constituents and the conformity assessment of interoperability constituents are set forth in Part Two of Government Regulation No. 133/2005 Coll.

Act No. 266/1994 Coll. , in Section 3, stipulates that the national rail network is part of the European rail system.

Terms and definitions used: The

European rail system is a structure composed of the components of the European rail system, built or modernized for high-speed or conventional rail transport and for combined rail transport, and the fleet of rail vehicles intended for operation on this rail system.

Subsystems are defined in Annex II of Directive 2008/57/EC; they may be structural or functional (operational—maintenance, telematic applications).

Structural subsystems: infrastructure (INS), energy (ENE), control-command and signaling (CCS), on-board control-command and signaling (CCS), rolling stock (RST)

Functional subsystems: operation and traffic management (OPE), maintenance, use of telematics in passenger and freight

transportComponents of the interoperability of the European rail system include all components of the track and rolling stock on which the interoperability of the European rail system directly or indirectly depends; components of interoperability include both tangible and intangible objects, such as software.

Interoperability of the European rail system is the ability of the European rail system to enable, in compliance with the technical specifications for interoperability (TSIs published in the Official Journal of the European Union), operational and technical connectivity, safe and uninterrupted operation of rail vehicles on the track, and to ensure the required level of performance, safety, and quality of transport.

Interoperability
constituentsInteroperability constituents may be placed on the market and put into service only if they enable the achievement of interoperability of the European rail system and, at the same time, comply with the technical specifications for interoperability and the essential requirements for design and operational characteristics pursuant to Decree No. 352/2004 Coll. Interoperability constituents may only be used for the purposes specified in the technical documentation or in the technical specifications for interoperability. Interoperability constituents must be installed, operated, and maintained in accordance with the technical documentation and the technical specifications for interoperability. When interoperability constituents comply with the technical specifications for interoperability, the essential requirements for interoperability constituents are deemed to be met. In the absence of technical specifications for interoperability, interoperability constituents must comply with European specifications. Compliance with the requirements for interoperability constituents set forth in Section 3 of Government Regulation No. 133/2005 Coll. is established through a conformity assessment procedure.

The conformity assessment of an interoperability constituent or its suitability for use in the relevant subsystems is carried out in accordance with:

• the technical specification for interoperability governing the interoperability constituent;
• Decision No. 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products and repealing Council Decision 93/465/EEC (provided that the relevant technical specification for interoperability entered into force no later than December 31, 2010)
• Commission Decision No. 2010/713/EU on the modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council (if the relevant technical specification for interoperability entered into force after December 31, 2010)

Annex I to Commission Decision No. 2010/713/EU on modules for the procedures for conformity assessment, suitability for use, and EC verification to be used in technical specifications for interoperability adopted on the basis of Directive 2008/57/EC of the European Parliament and of the Council states:

• Modules for the conformity assessment of interoperability constituents
• Modules for the assessment of the suitability for use of interoperability constituents
• Modules for the EC verification of subsystems

Modules for the conformity assessment of interoperability constituents
Module CA	Internal production control
Module CA1	Internal production control plus product verification based on individual checks
Module CA2	Internal production control plus product verification at random intervals
Module CB	EC type examination
Module CC	Conformity to type based on internal production control
Module CD	Conformity to type based on a quality management system for the production process
Module CF	Conformity to type based on product verification
Module CH	Conformity based on a comprehensive quality management system
Module CH1	Conformity based on a comprehensive quality management system and design examination
Modules forof suitability of interoperability constituents for use
Module CV	Type verification based on in-service experience (suitability for use)
Modules for EC verification of subsystems
Module SB	EC type examination
Module SD	EC verification based on a production process quality management system
Module SF	EC verification based on product verification
Module SG	EC verification based on verification of each individual product
Module SH1	EC verification based on a comprehensive quality management system and design examination

TSIs assess interoperability constituents atstages of design and development or production, or all of these as a whole.

The assessment of conformity or suitability for use of interoperability constituents is requested by the manufacturer and carried out by a notified body. If the interoperability constituent and the activities related to its manufacture or, where applicable, use meet the requirements under Section 3 of Government Regulation No. 133/2005 Coll., the notified body shall issue a type examination certificate, a certificate of conformity, a certificate of suitability for use, or another document specified in the regulations (768/2008/EC, 2010/713/EU). An entity other than a notified body may perform conformity or suitability for use assessments only if permitted by Regulations: 768/2008/EC, 2010/713/EU.

The output document of the Notified Body is a type examination certificate, a certificate of conformity, a certificate of suitability for use, or another document issued by the Notified Body, or, where applicable, based on the manufacturer’s internal control report on the product’s conformity with the technical specifications for interoperability. The manufacturer or its authorized representative then demonstrates the conformity of the interoperability constituent by issuing an EC declaration of conformity with the technical specifications for interoperability, of conformity with European specifications, or of conformity with the examined type; and for specified interoperability constituents pursuant to paragraph 2 of Section 4 of Government Regulation No. 133/2005 Coll., demonstrates their suitability for use by issuing an EC declaration of suitability for use.

The content of the EC Declaration of Conformity and the EC Declaration of Suitability for Use is set forth in Annex No. 1 to Government Regulation No. 133/2005 Coll. A prerequisite for the issuance of these declarations is the application of the provisions of the technical specifications for interoperability during manufacture or, where applicable, during the verification of the component’s conformity.

Interoperability constituents for which an EC Declaration of Conformity or an EC Declaration of Suitability for Use has been issued are considered to be constituents that meet the essential requirements and conditions set out in the relevant technical specifications for interoperability.

Exception: For spare parts for subsystems that are already in service at the time the relevant technical specifications for interoperability enter into force, an assessment of conformity and suitability for use is not required.

The conformity assessment procedure for interoperability constituents carried out by the NO during the design and construction phases of the subsystem must comply with the conditions set forth in the technical specifications for interoperability. If no specific procedure for assessing the conformity of interoperability constituents is set forth in the relevant technical specification for interoperability, in Government Regulation No. 133/2005 Coll., or in the implementing regulation to the Railways Act, then the procedure shall be in accordance with specific regulations, e.g., regulations establishing technical requirements for: selected construction products bearing the CE marking, transportable pressure equipment, pressure equipment, products in terms of their electromagnetic compatibility, and low-voltage electrical equipment. The EC Declaration of Conformity or EC Declaration of Suitability for Use shall then state under which regulation the components were assessed and whether they meet the technical requirements set forth in that regulation.

The manufacturer or its authorized representative who places interoperability constituents on the market within the EU must keep the EC Declaration of Conformity, the EC Declaration of Suitability for Use, and the technical documentation available to the competent national authority for the period specified by the relevant TSI. If this period is not specified in the TSI, then these documents must be kept for 10 years from the date on which the last interoperability constituent was manufactured. This applies to interoperability constituents manufactured in the EU as well as to those imported from a third country. If this obligation has not been fulfilled by the manufacturer or its authorized representative in the EU, then it must be fulfilled by the person who placed the interoperability constituent on the EU market (the importer).

Subsystems

,

The procedure for verifying subsystems and the content of the EC declaration of verification of a subsystem are set forth in Annex No. 2 to Government Regulation No. 133/2005 Coll.

Preliminary opinion on the type examination of a subsystem or preliminary opinion on the verification of a subsystem (Section 6a of Government Regulation No. 133/2005 Coll.)

During the overall project phase or the subsystem implementation phase, the subsystem operator or its authorized representative may request a notified body to issue a provisional opinion on the type examination of the subsystem or a provisional opinion on the verification of the subsystem. The procedure for verifying subsystems and the content of the EC declaration of verification of the subsystem are set forth in Annex No. 2 to Government Regulation No. 133/2005 Coll.

Preliminary verification of the subsystem shall be carried out to the extent of:

a) the entire subsystem at one of the stages of subsystem verification, or

b) a part of the subsystem at one of the stages of subsystem verification or at all stages simultaneously.

Supplementary EC Declaration of Verification of the subsystem (Section 6b of Government Regulation No. 133/2005 Coll.)

In the event of a modification to the basic design characteristics of the subsystem that are significant for compliance with the basic parameters defined in the technical specifications for interoperability, the operator of a subsystem holding a subsystem verification certificate shall request the notified body to examine the subsystem to the extent of its modified part, including the interface with the unmodified part of the subsystem. If an EC declaration of verification has been issued for the modified subsystem, the subsystem operator shall issue a supplementary EC declaration of verification for the subsystem, in which it shall also define the basic parameters affected by the modification of the subsystem. The supplementary EC declaration of verification of the subsystem shall be accompanied by:

a) a list of documents from the original technical documentation file affected by the modification of the subsystem

,

and

b) a technical documentation file that includes a document proving that the modification of the subsystem is limited to the basic parameters defined in the supplementary EC declaration of verification of the subsystem.

In the case of a modification to the subsystem other than that specified in Section 6b of Government Regulation No. 133/2005 Coll., the subsystem operator must update the technical documentation file attached to the EC declaration of verification of the subsystem, including references to the technical documentation in the EC declaration of verification of the subsystem. If maintenance or repair of the subsystem is performed by replacing subsystem parts, the procedure under Section 6b of Government Regulation No. 133/2005 Coll. shall not apply.

 

European

SpecificationsEuropean specifications are European technical specifications and harmonized Czech technical standards pursuant to Section 4a of Act No. 22/1997 Coll. Harmonized European standards are published in the Official Journal of the EU. If there are no European technical specifications or harmonized Czech standards for the relevant area, the standards designated by ÚNMZ as European specifications shall apply.

Technical Specifications for Interoperability (TSI)

The European rail system consists of subsystems and components (elements); it is a highly complex structure, and therefore it was necessary to introduce technical specifications for interoperability (TSI) to ensure mandatory interoperability. TSIs facilitate the transition from older integrated national railway systems to a shared European railway system, which is governed primarily by common EU regulations. TSIs generally do not prescribe specific technical solutions for meeting the requirements.

TSIs are adopted by Commission Decisions or Commission Regulations (EU) and are binding in their entirety and directly applicable in all Member States:

• Commission Decision No. 2012/757/EU – CCS TSI (the “traffic operation and management” subsystem of the EU rail system)
• Commission Regulation (EU) No. 1299/2014 – TSI (the infrastructure subsystem of the EU rail system)
• Commission Regulation (EU) No. 1301/2014 – TSI ENE (energy subsystem of the EU rail system)
• Commission Regulation (EU) No. (EU)2016/919 – TSI (control-command and signaling subsystems of the EU rail system)
• Commission Regulation (EU) No. 1303/2014 – SRT TSI (Safety in Railway Tunnels of the EU Rail System)
• Commission Regulation (EU) No. 1300/2014 – PRM TSI (Persons with Disabilities and Persons with Reduced Mobility)
• Commission Regulation (EU) No. 454/2011 – TSI (subsystem “telematics applications for passenger services” of the trans-European rail system)

The TSI sets out all the conditions for meeting the interoperability constituent and the procedure for assessing conformity. Each interoperability constituent must be assessed for conformity and suitability for use as specified in the TSI and must have the corresponding certificate. Subsystems must comply with the individual TSIs in force at the time of their placing in service, upgrading, or renewal. The territorial scope of a TSI is determined by the revision of existing TSIs or the adoption of new TSIs, while the original territorial scope of the TSI remains in force.

The TSIs referred to in Commission Regulation (EU) are generally divided into 7 main chapters and annexes:

1. Introduction – Technical Scope
2. Definition of the subsystem and scope
3. Essential requirements for subsystems
4. Description of subsystems
5. Interoperability constituents
6. Conformity assessment and/or suitability for use of constituents and verification of the subsystem
7. Implementation of TSIs for subsystems

The annexes to the TSIs contain the actual technical specifications, references, figures, and tables.

TSIs may refer to European or international standards, specifications, or technical documentation published by the European Railway Agency (ERA). If these do not exist, TSIs may refer to other specific designated normative documents (UIC leaflets—International Union of Railways), national standards, etc. Compliance with these standards, specifications, and documentation cited in the TSIs becomes mandatory. Compliance with harmonized standards establishes a presumption of conformity with the corresponding essential requirements. The ERA website also publishes guides to the relevant TSIs, which include lists of applicable standards and other documentation. For example: The European Railway Agency has published a Guide for the Application of Technical Specifications for Interoperability (TSIs). This guide explains how interoperability constituents and subsystems should be assessed in relation to compliance with the essential requirements set forth in Directive 2008/57/EC.

If subsystems are not covered by a TSI or if the technical aspects corresponding to the essential requirements cannot be explicitly included in the TSI (due to their complexity or lack of time), they must be clearly identified as “open points” in the annex to the relevant TSI. In this case, the open point is governed by “Notified national technical rules.” A subsystem that complies with all applicable TSIs and has no “open points” should be considered to meet the essential requirements of the Interoperability Directive.

The following TSIs are available on the website of the European Railway Agency (ERA):

Locomotives and passenger rolling stock - LOC & PAS TSI
Noise - NOI TSI
Wagons - WAG TSI	(cars)
Infrastructure - INF TSI	Infrastructure
Energy - ENE TSI	Energy
Control, Command, and Signaling - CCS TSI	Control, Command, and Signaling
Persons with Reduced Mobility - PRM TSI	Persons with Reduced Mobility
Safety in Railway Tunnels - SRT TSI	Safety in Railway Tunnels
Operation and Traffic Management - OPE TSI	Operation and Traffic Management
Telematics Applications for Freight Services - TAF TSI	Telematics Applications for Passenger Transport / Use of Telematics in Passenger Transport
For your information: All TSIs for railway interoperability issued by the ERA, sorted chronologically: http://www.era.europa.eu/Document-Register/Documents/TSIs-chronology.PDF
website of ACRI (Association of Czech Railway Industry Enterprises): abbreviations used primarily in European legislation concerning railway interoperability

Reference Document

The purpose of the reference document is to facilitate the procedure for authorizing the placing of vehicles into service by:

a)    providing a list of all parameters that should be checked in connection with the authorization to place vehicles into service;

- the annex to Commission Decision No. 2009/965/EC sets out a list of parameters (these parameters are further subdivided):

1. Documentation
2. Design and mechanical components
3. Interaction with the track and vehicle gauges
4. Braking
5. Passenger-related items
6. Environmental conditions and aerodynamic effects
7. Requirements for external warning, signaling, marking functions, and software integrity
8. On-board power supply and control systems
9. Equipment, interfaces, and environments for staff
10. Fire safety and evacuation
11. Maintenance
12. On-board control and signaling
    Specific operational requirements
13. Items relating to freight

(b) identify all rules applied by Member States for the authorization of vehicles to be placed in service;
c) relate each rule to one of the parameters to be checked in connection with the authorization for placing vehicles into service;
d) classify all regulations into groups A, B, or C in accordance with Part 2 of Annex VII to Directive 2008/57/EC on interoperability;
e) in accordance with Article 1 of Decision 2009/965/EC, outline the national legal framework concerning the authorization of vehicles for placing in service.
14. Annex VII of Directive 2008/57/EC contains a list of indicators and the classification of regulations (Group A, Group B, and Group C).

The Agency shall publish and maintain reference documents on its website in the Reference Document Database (RDD).

The Agency shall draw up a recommendation for a reference document referencing all national regulations applied by Member States for the placing in service of a vehicle. National safety authorities shall cooperate with the Agency on this task. On the basis of the Agency’s recommendation, the Commission shall adopt the reference document and any decision on its update.

Legislation relating to the reference document:

Reference	Title
2009/965/EC (current version)	Commission Decision on the reference document referred to in Article 27(4) of Directive 2008/57/EC on the interoperability of the rail system within the Community
2011/155/EU	Commission Decision on the publication and management of the reference document referred to in Article 27(4) of Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community// Guidance on use – Part 1 of the reference document

The reference document referred to in Article 27(4) of Directive 2008/57/EC shall be drawn up on the basis of the list of parameters set out in the Annex to Commission Decision No. 2009/965/EC. This list of parameters shall be used for the classification of national rules in the RD referred to in Article 27 of Directive 2008/57/EC. The document shall also contain basic information on the national legal framework of each Member State applicable to the placing in service of railway vehicles.

The content of the reference document referred to in Article 27(4) of Directive 2008/57/EC is set out in the Annex to Commission Decision No. 2011/155/EU.

The Annex to Commission Decision No. 2011/155/EU is divided into three parts:

1. Purpose
2. of
3. the reference document
4. Structure and content
5. Scope of the reference document

The following registers are publicly available on the Agency’s website:

ERADIS	European Railway Agency Database of Interoperability and Safety
ERAIL	European Railway Accident Information links
ERATV	European Register of Authorized Vehicle Types
NOTIF-IT	- database for the notification of national railway safety and technical rules
RDD	The Reference Document Database (RDD)
RINF	Register of Railway Infrastructure
VKM Register	Vehicle Keeper Marking Register

(VKMR)

Other useful information:

• NB-RAIL – Recommendation For Use (RFU) – list of recommendations for subsystems prepared by the Coordination Group of Notified Bodies for Railway Products and Systems
• NB-RAIL – Questions & Clarification (Q&C) to the European Commission
• Blue Guide on the implementation of EU product rules (2016)
• ERTMS national technical rules (ERTMS European Rail Traffic Management System)