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1 Page 1 of 11 CONTENT OF THE TECHNICAL FILE TITLE ORIGINATOR SUBJECT RELATED TO NB-RAIL STRATEGY SG Directive 2008/57/EC (incl. all amendments esp. 2014/106/EU), Recommendation 2014/897/EU, Decision 2010/713/EU and all TSIs AMENDMENT RECORD: ISSUE 07: ADJUSTMENT OF SECTION 3 OF TF IN LINE WITH RFU-STR-001 ISSUE 10. ALSO SMALL CHANGES TO INCREASE REDABILITY. INCLUDING OF WKD-STR-007 ISSUE 01 AS ANNEX TO THIS DOCUMENT. DESCRIPTION AND BACKGROUND EXPLANATION Based on 2008/57/EC as modified by 2014/106/EU (applicable from ) and supported by recommendation 2014/897/EU the previous concept of the Technical File (TF) was re-defined and the associated tasks have been re-allocated between Applicant and NoBo: The Applicant prepares and manages a Technical file accompanying the EC declaration of verification (in the following abbreviated as ECDV-TF) and the NoBo a Technical File accompanying the EC Certificate of Verification (in the following abbreviated as NoBo- TF). One or several individual NoBo-TF(s) form a part of the overall ECDV-TF. ECDV-TF ( Technical File accompanying the EC declaration of verification ) According to 2008/57/EC and 2014/897/EU to be prepared by the Applicant for Authorisation for Placing in Service (APIS), either for a Structural Subsystem, or a Vehicle, or a Network Project) 1. Technical Characteristics (=Design evidence documentation) 2. List of ICs 3. NoBo-TF (may be a collection of several NoBo- TFs) 4. DeBo-TF-xx (xx= MS abbreviation, may be a collection of several DeBo-TFs) 5. Certificates relating to other legislation derived from the Treaty 6. AsBo Report (on the verification of safe integration) 7. Information required for the relevant registers (e.g. ERATV/ RINF/ NVR) 8. Other information as required by IOD 2008/57/EC 9. Other information as recommended by 2014/897/EU Annex to ECDV-TF containing all referenced documents NoBo-TF (Technical File accompanying the EC Certificate of Verification) According to 2008/57/EC to be prepared by the NoBo for : a Structural Subsystem 1. Actors 2. NoBo Certificates 3. Conditions and Limits of use 4. Project scope and definition 5. Project documentation 6. EC verification process information

2 Page 2 of 11 Note: This RFU is only intending to define the required Content for the NoBo-TF. Any contents of the ECDV-TF are only listed for general information and are not intended to be complete. An advantage of having a standardised layout of the NoBo-TF is that any interested stakeholders will become able to locate information easily at the same section across any TF prepared in accordance with this RFU. The project-specific content of each section will vary according to the nature of the project, the subsystems involved and the assessment modules used. For IC certification Modules and for Modules SB and SH1 (design examination) a different situation applies: Instead of a Technical File, in these cases 2010/713/EC defines a concept of annexes to the certificate, which shall contain all relevant information to allow the conformity of interoperability constituents or manufactured subsystems with the product type examined to be evaluated. This annex is required to provide the relevant information from the NoBo which has performed a certification to another NoBo performing the final subsystem certification or quality management system approval. Despite the different names, the content of information required for the NoBo-TF and for the annexes to the certificates is identical, so the same document structure as given in the annex of this RFU should be used and the term NoBo-Technical File should be used instead of annexes to the certificates. For Information: Unless other (e.g. national) requirements apply, the DeBos are invited to use for a DeBo-TF the same structure as defined in this RFU, in order to achieve a systematic structure across all NoBo and DeBo sections of the ECDV-TF. Further references on the overall relevant legislative background to this RFU are contained in the annex to this document. RFU PROPOSAL Structure for the Technical File accompanying the EC Certificate of Verification (in the following abbreviated as NoBo-TF) The content and format shown in this RFU are combining the minimum requirements only. Any further specific requirements as may be defined for certain types of products by the Interoperability Directive, the individual TSIs and by contractual obligations must be observed in addition. The language(s) of the NoBo-TF shall be defined by In relation to document control aspects, the NoBo-TF shall have:

3 Page 3 of 11 A Cover Page identifying the Project/ Product/ Installation and Certificate to which it relates A Unique document ID A Version Control (incl. short description of changes in the respective version) A Table of Contents Page Numbers in the format x of y (to permit quick verification of completeness). In the event that a certain project does not need to use any particular section, this section should be retained and marked as not used (or similar) so as to keep section numbers identical across all NoBo-TFs. In many cases the information in the subheadings may be provided in the format of references to relevant documents which have been supplied by section Title of section Explanation 1 Actors (Heading only) 1.1 Notified Body(s) Identification of NoBo(s) involved in the assessment and their respective scope of assessment (including ISVs). 1.2 Applicant Identification of Applicant. 2 Notified Body Certificate(s) 3 Conditions and Limits of use 4 Project Scope and Definition 4.1 General Project information This shall contain copies of all subsystem certificates issued by the NoBo(s) (including any ISV(s), if used). This shall contain references to the Conditions and Limits of use as declared by the Applicant to the NoBo. If necessary, the NoBo must state also any further Conditions and Limits of use, if these were identified during the EC verification. Individual TSIs may require further specific information to be provided by the Applicant (e.g. choice of environmental condition parameters in TSI CCS or L&P). Where defined in a TSI this shall include the Area of Use information as far as this is to be evaluated by the NoBo. (Heading only) Precise definition of the Product/ Installation under certification. Where relevant, this shall reference the precise Variant/Version of a type, line locations, etc.

4 Page 4 of Technical scope and interfaces Individual TSIs may require further specific information to be provided by the Applicant (e.g. e.g. choice of optional functions in TSI CCS). Additionally: in case of application for an ISV, detailed description of the part/stage under assessment is required. This shall define the scope of the verification clearly, e.g. the geographic and technical scope of assessment, interfaces to other subsystems, and special considerations. 4.3 Project History Overview of relevant aspects of the project history and any phasing of activities. In particular for long lasting projects which started before a current TSI became applicable, this information of project history (e. g. date of application and amendments, date of derogations, start of construction works etc.) is indispensable to explain which TSI version is used for the project. This shall justify why a particular TSI version is used or why certain TSI s are not applied or are applied only in parts and resulting in requirements or test methods to be different from a current TSI. 4.4 Derogations/ Limitation of TSI Application Reference to documented evidence on any Derogations enjoyed or expected under 2008/57/EC Art 9 or Limitations to TSI application under Art 20 as agreed between the Applicant and the NSA(s). 4.5 List of specific cases Reference listing on the Specific Cases declared by the Applicant to be present at this project (refer to ch.7 of the relevant TSIs). 5 Project documentation 5.1 Applied Standards/ Technical Specification/ Alternative Solutions (Heading only) The following sub-headings shall refer to all of the technical documentation supplied to the NoBo by the Applicant and used during verification activities. It is good practice to provide the information for 5.1 / 5.2 within a combined matrix. This shall contain for each applicable TSI Parameter/ Requirement the harmonised standards and/or other relevant technical specifications applied in full or in part, and

5 Page 5 of 11 descriptions of the alternative solutions adopted where those have not been applied. In the event of partly applied harmonised standards or technical specifications, state also which parts have been applied. This section also lists the applied RFUs and ERA TOs/TAs. 5.2 Design evidence This shall contain for each applicable TSI Parameter/ Requirement the references for the design evidence documents used during the EC verification. Documents which do not relate to the final EC certification should be avoided. Depending on the individual TSI Parameter/ Requirement, this may be one or several of the following: drawings, parts lists, functional/ technical descriptions, simulations, test procedures, test reports, etc. Individual TSIs/ Standards/ Technical Specifications may require further specific information to be provided by the Applicant (e.g. choice on specific tests in operational conditions in TSI CCS or L&P). 5.3 Evidence related to quality management system(s) or on production (depending on the modules used) References to information on the applied quality management system. This may include references to: an ISO 9001 quality management system or other relevant certificates on specific quality management systems (e.g. to EN15085) quality management approvals from notified bodies, information on relevant QM documents (e.g. procedures, quality planning, production related testing and inspection, etc.) These References have typically been identified during the QMS audit activities. If no quality management system is used during the project (e. g. where Module SG or SF has been applied), then the production evidence required to demonstrate conformance of the installation or

6 Page 6 of List of manufacturers and main subcontractors 5.5 Provisions for operation 5.6 Provisions for maintenance 5.7 Interoperability Constituents 6 EC verification process information and results conformance of the product with the type shall be included. This may include installation or product inspections, test reports and other documentation as required by the module(s) used. In complex situations this shall also include an overview on roles and responsibilities. This shall contain in accordance to the relevant TSIs the references to the Applicant documents which contain those provisions for operation which must be assessed by the NoBo. (e.g. operation manual) This shall contain in accordance to the relevant TSIs the references to the Applicant documents which contain those provisions for maintenance which must be assessed by the NoBo. (e.g. maintenance file) This shall include the reference to the Applicant s list of ICs and to the associated EC Declarations of Conformity or Suitability for Use, associated Certificates and NoBo-TFs and the Applicant s Technical Documentation. This shall include at least all information required to assure the correct integration of the IC into the subsystem e.g. - interface definitions - conditions for use - maintenance & operation information. This section includes the documents prepared by the NoBo(s). This shall include the reference to the NoBo Report(s) (and where existing, further supporting documentation) related to the applied Modules. (Note: If a NoBo does not issue separate reports, the respective information shall be provided in this section.)

7 Page 7 of 11 THIS RFU WAS AGREED ON PLENARY MEETING 53 DATE OF PUBLICATION: 14/06/ /09/2018 THIS RFU ENTERS INTO FORCE ON RFU APPLICATION IS MANDATORY STARTING FROM AT THIS DATE ANY PREVIOUS VERSIONS (OR, ALTERNATIVELY, VERSION XX) OF THIS RFU WILL BE WITHDRAWN. PLE053-23/05/2018: NO COMMENTS ERA COMMENTS

8 Page 8 of 11 ANNEX 1: The list below has been established to provide an overview of the legal framework dealing with the topic of technical file extended to the notion of technical file accompanying the EC declaration. This list is intended for the general information of Applicants and NoBos and is not intended to be complete. I. Requirements for Content of NoBo-TF: VI.2.4.c-1.1 VI.2.4.c-1.2 VI.2.4.c-2.1 VI.2.4.c-2.2 VI.2.4.c-3.1 VI.2.4.c /897/EU 56 copies of the EC declarations of conformity and, where applicable, EC declarations of suitability for use established for interoperability constituents referred to in Article 5(3)(d) where appropriate [as defined in the TSIs] the corresponding calculation notes and a copy of the records of the tests and examinations carried out by the notified bodies on the basis of the common technical specifications where available, the [relevant] ISV[s] that accompany the [Subsystem] certificate of verification, Including the result of verification by the notified body[s] of the ISV[s] validity [=is/are the ISV(s) presented actually valid and applicable for this subsystem] the [EC] certificate of verification signed by the notified body responsible for the verification stating that the subsystem complies with the requirements of the relevant TSI(s) and mentioning any reservations recorded during performance of the activities and not withdrawn certificate of verification should also be accompanied by the inspection and audit reports drawn up by the same body in connection with its task, as specified in points (surveillance audits) and (unexpected visits) This implies that the notified body has a role in checking technical compatibility with other subsystems, which is consistent with the fact that technical compatibility is covered by TSIs. The scope of these checks is limited to the relevant TSIs. Each notified body compiles a technical file in respect of the verifications they have carried out. section5.7 section6 section2 section6 section2. EC Certificates according to RFU-STR-001 will satisfy this. section6. It is considered that this relates only to those surveillance audits/ unexpected visits performed up to the date of EC certification. >General Requirement for NoBo-TF. All content of the NoBo-TF shall be limited to the relevant TSIs and the verifications the NoBo has carried out.

9 Page 9 of 11 II. Requirements for Content of ECDV-TF VI.2.4.a VI.2.4.b VI.2.4.d VI.2.4.e VI /57/EC 23.3.b 2008/57/EC 25.2.a [set of documents on] technical characteristics linked to the design including general and detailed drawings with respect to execution, electrical and hydraulic 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; a list of interoperability constituents, referred to in Article 5(3)(d), incorporated into the subsystem; certificates of verification issued in accordance with other legislation deriving from the Treaty; when verification of safe integration is required pursuant to Article 15, the relevant technical file shall include the assessors' report(s) on the common safety methods (CSM) on risk assessment referred to in Article 6(3) of Directive 2004/49/EC. Language The files and correspondence relating to the EC verification procedure must be written in a Union official language of the Member State in which the contracting entity or manufacturers (i.e. the applicant in the meaning of Article 18) is established or in a Union official language accepted by the contracting entity or manufacturers (i.e. the applicant in the meaning of Article 18). This shall include, in the case of vehicles equipped with data recorders, information on the data collection procedure, permitting read out and evaluation, as long as this information is not harmonised by the corresponding TSI; In case of Additional authorisations for placing in service of non- TSI conform vehicles: documentary evidence that the placing in service of the vehicle has been authorised in another Member State together with documentation on the procedure followed in order to show that the vehicle complied with the safety requirements in force, including, where applicable, information on May be combined or separate for all Member States, where operation is intended. >It is a requirement for the Applicant to agree on the primary and any secondary languages/ translations with the related NSA(s). >The NoBo may accept and will prepare documents in any languages they have contractually agreed upon with the Applicant. derogations enjoyed or granted in accordance with Article 9; 2008/57/EC 25.2.b-1 the technical data, 2008/57/EC 25.2.b-2 the maintenance programme 2008/57/EC 25.2.b-3 the operational characteristics 2008/57/EC 25.2.b-4 This shall include, in the case of vehicles equipped with data recorders, information on the data collection procedure, permitting read out and evaluation as provided for in Article 20(2)(c) of Directive 2004/49/EC; 2008/57/EC 25.2.c-1 records showing the vehicle's history of operation, maintenance 2008/57/EC 25.2.c-2 where applicable, technical modifications undertaken after the authorisation; 2008/57/EC 25.2.d evidence on technical and operational characteristics that shows

10 Page 10 of /897/EU 2(m) 2014/897/EU /897/EU /897/EU /897/EU 40bis that the vehicle is compatible with the infrastructures and fixed installations, including climate conditions, energy supply system, control- command and signalling system, track gauge and infrastructure gauges, maximum permitted axle load and other constraints of the network. technical file accompanying the EC declaration of verification means the combination of all files and documentation gathered by the applicant as required by all applicable EU legislation for a subsystem; (Vehicles) technical characteristics of the vehicles' design operating state, including limits and conditions of use and indicate the network(s) of the Member State(s) for which the vehicles of that type are authorised. The technical characteristics referred to in the authorisation should be: declared by the manufacturers or contracting entities, in their role as applicant for authorisation of the vehicle or vehicle type, verified and certified by the assessment bodies, and documented in the technical file accompanying the EC declaration of verification. (fixed installation Subsystem) fixed installation subsystems should refer to its technical characteristics, including limits and conditions of use. The technical characteristics referred to in the authorisation for placing in service should be: declared by the applicant, verified and certified by the assessment bodies, and documented in the technical file accompanying the EC declaration of verification. (VEHICLES) points (a), (b), and (c) of recommendation 39 ((a) safe integration between the elements composing a subsystem; (b) safe integration between subsystems that constitute a vehicle or a network project; and, for vehicles: (c) safe integration of a vehicle with the network characteristics; ) should be carried out before authorisation for placing in service. Any condition and limits of use derived from them (e.g. any limitations for train composition including operation in multiple units or operation of the locomotives together with the vehicles forming the train) should be stated in the technical file accompanying the EC declaration of verification referred to in Article 18(3) of Directive 2008/57/EC in such a way that the user of the authorised subsystem or vehicle can apply these conditions and limits of use according to its SMS, (fixed installation Subsystems/ Network Projects) points (a), (b), (f) and (g)( (a) safe integration between the elements composing a subsystem; (b) safe integration between subsystems that constitute a vehicle or a network project; (f) safe integration of a network project with the vehicle characteristics defined in TSIs and national rules; (g) safe integration with adjacent parts of the network (line sections); ) of recommendation 39 should be carried out before authorisation for placing in service. Any condition and limits of use derived from them should be stated in the technical file accompanying the EC declaration of verification referred to in Article 18(3) of Directive 2008/57/EC in such a way that the user of the authorised subsystem or network project can apply these conditions and limits of use according to its SMS, 2014/897/EU 90-1 According to Article 18 and Annex VI to Directive 2008/57/EC, an

11 Page 11 of 11 EC declaration of verification for a subsystem should be accompanied by a technical file 2014/897/EU 90-2 including the documentation describing the subsystem, 2014/897/EU 90-3 the documentation resulting from the verifications carried out by different assessment bodies 2014/897/EU 90-4 and the documentation of the elements relating to the conditions and limits of use 2014/897/EU 90-5 and to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance. 2014/897/EU 90-6 the technical file accompanying the EC declaration of verification includes all supporting documents needed for the authorisation for placing in service. 2014/897/EU 99 Each manufacturer, maintenance supplier, wagon keeper, service provider and procurement entity must ensure that rolling stock, installations, accessories and equipment and services supplied by them comply with the essential requirements and that the conditions for use are specified in the technical file accompanying the EC declaration of verification so that they can be safely put into operation by the railway undertaking and/or infrastructure manager. >It is a requirement for the Applicant to agree these aspects with the relevant stakeholders.