1. Workshop accreditation and recognition / conformity assessment Removing Technical Barriers - TSIs within New Approach and Safety Directive Dr.-Ing. Andreas SCHIRMER 13 and 14 April 2016

2. New Approach Principles in Railways 2 The Interoperability Directive has adopted the principles of new approach Directives: Essential requirements (ERs) in Interoperability Directive The applicant shall meet all ERs applicable to the product Voluntary harmonised standards = presumption of conformity Third party assessment by NoBo (checks conformity against the TSI) The applicant declares conformity with all applicable legislation Technical file contains the subsystem´s limits and conditions of use

3. Railway Safety Directive 3 Railway specific addendum: Railway Safety Directive Railway Safety Directive (RSD) allocates responsibility for safe operation and risk control to the RUs, IMs and ECMs  Extension of New Approach to the user´s side Technical file with the subsystem´s limits and conditions of use is the mean of communication between manufacturer and users

4. Political interests 4 Reduction of CO 2 emissions, Relief of road traffic, … Increase rail share in the modal split Improvement of competitiveness Interoperability! (TSIs) Market opening! (New Approach)

5. Interoperability 5 Interoperability Uninterrupted movement of trains Basis harmonisation (to achieve compatibility RST-network) Additional harmonisation (to achieve one single APS for RST ) → Technical Specifications Interoperability (TSI) (within the “New Approach” and the Safety Directive)

6. Technical Specifications Interoperability (TSI) 6 Goal: „Interoperability“ while keeping new approach principles TSI is law Deviation impossible, derogation very time consuming.  As concise as possible – as extensive as necessary! Most possible flexibility (= responsibility!) for the player -only subsystem-related technical parameters critical for interoperability (basic parameters) - only functional requirements - no technical solutions required All TSI requirements shall comply with the essential requirements concerned

7. Subsystems Transversal Accessibility Tunnels Noise Energy Signalling Infrastructure Locos and coaches Wagons Telematics for freight Telematics for freight Telematics for passengers Telematics for passengers Operation TSIs 2015 (applicable to whole EU railway network) 7

8. Responsibilities before placing into service (1/2) 8 The applicant has to comply with all applicable legislation, in particular he has to meet all essential requirements in relation to the design operating state (product + limits and conditions of use). The notified body (NoBo) checks against the TSI requirements The designated body (DeBo) checks against notified national technical rules (NNTRs) rel. to open points and specific cases and class B CCS legacy systems, if any The CSM assessor checks the explicit risk analysis if required by TSI or if applicant decided to apply it within the CSM The national safety authority (NSA) grants the authorisation for placing in service on the basis of the declaration of verification issued by the applicant (check of completeness of procedure, no technical checks)

9. Class B CCS SC not set out in TSIs OPOP TSIs Vehicles: L&P WAG CCS NOI SRT PRM Network: INF ENE CCS SRT PRM ERs in IOD + Quality Management System other EU legislation Applicant is responsible that its products + limits/conditions of use comply with all applicable legislation NoBo assesses compliance with TSIs and QMS (AsBo involvement if required by TSIs) DeBo assesses compliance with NTRs Assessments depending on other EU legislation EC declaration of verification Technical File NSA grants Authorisation (no additional technical checks) Responsibilities before placing into service (2/2) 9

10. Responsibilities after placing into service (1/2) 10 The RU/IM/ECM is responsible for the safe operation on the basis of a safety management system (SMS) (Article 4(3) of the Safety Directive) →that contains the - establishment of the compatibility of the train with the route on the basis of the information of the infrastructure manager - safe integration into the existing maintenance and operation system →the part of the technical file with the limits and conditions of use enables the RUs/IMs/ECMs to take their responsibility The NSA grants the safety authorisation (for IMs) and the safety certificate (for RUs) and monitors the application of the SMS The NSA carries out the market surveillance for ICs

11. SC not set out in TSIs OPE TSI OP Safe Operation + Safety Management System Class B CCS other EU legislation RUs, IMs responsible for safe operation and compliance with all applicable legislation NSAa monitores and supervises application of SMS (AsBo involvement in case of substantial changes) Supervision depending on other EU legislation (e.g. Health at work) Technical File NSAa grants safety cert. (RUs) safety auth. (IMs) after check of SMS Application File Other NRs Responsibilities after placing into service (2/2) 11

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