EU railway interoperability directive - conformity framework for subsystems and interoperability constituents.
The Directive lays down the conditions for achieving interoperability of the Union rail system: it divides the system into structural subsystems (infrastructure, energy, trackside and on-board control-command and signalling, rolling stock) and functional subsystems (operation and traffic management, maintenance, telematics applications) in accordance with Annex II, sets out essential requirements (safety, reliability and availability, health, environmental protection, technical compatibility, accessibility for persons with disabilities) in Annex III, including point 1.4.3 on electromagnetic compatibility, and delegates technical detail to the TSIs adopted by the Commission.
An interoperability constituent (Article 2(7)) is any elementary component, group of components, subassembly or complete assembly of equipment incorporated or intended to be incorporated into a subsystem. The Directive does not cover road vehicles or products outside the Union rail system.
A component enters the rail system by one of two routes. If a TSI identifies it as an interoperability constituent, the manufacturer applies the procedures specified in the TSI (modules from Decision 2010/713/EU), obtains a notified-body certificate where required, and issues a dated and signed EC declaration of conformity or suitability for use (Articles 9–10); Member States may not require repeat checks already covered by that procedure (Article 8).
A component that is not an interoperability constituent (relay, power supply, pushbutton) does not have its own EC declaration under Directive (EU) 2016/797; its suitability is assessed by the notified body during EC verification of the subsystem (Article 15) on the basis of evidence supplied by the manufacturer. A manufacturer's document stating “compliant with 2016/797” is therefore supporting evidence for the integrator.
The applicant (vehicle manufacturer or infrastructure manager) commissions a notified body to carry out the EC verification procedure for the subsystem in accordance with the TSIs and issues an EC declaration of verification (Article 15); authorization for placing a vehicle on the market is issued by the European Union Agency for Railways or the national safety authority.
For interoperability constituents, conformity is established by meeting the conditions of the TSI or relevant European specifications; spare parts for subsystems already placed in service before the TSI entered into force may be installed without this procedure (Article 9(5)).
TSIs (for example LOC&PAS, PRM, CCS, ENE and INF) define basic parameters, cite EN standards and identify which elements are interoperability constituents; the Commission maintains the list of notified bodies (NANDO), and ERA publishes TSI application guides.
Check whether the component is an interoperability constituent under the applicable TSI (if so, require the EC declaration and notified-body certificate); if it is not, check what evidence the manufacturer provides for EC verification of the subsystem, such as reports to standards cited by the TSI, for example EN 50155, EN 50121-3-2 and EN 45545-2.