# Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (recast) (Text with EEA relevance), Division 2.4: Technical file accompanying the ‘EC’ declaration of verification.

Extent: E+W+S+N.I.

The technical file accompanying the ‘EC’ declaration of verification shall be assembled by the applicant and must contain the following:
(a) 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;
(b) a list of interoperability constituents, referred to in point (d) of Article 4(3), incorporated into the subsystem;
(c) the files referred to in Article 15(4), compiled by each of the notified bodies involved in the verification of the subsystem, which shall include:
copies of the ‘EC’ declarations of verification and, where applicable, ‘EC’ declarations of suitability for use established for interoperability constituents referred to in point (d) of Article 4(3) and accompanied, where appropriate, by 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 ISV that accompany the certificate of verification, including the result of verification by the notified body of the ISV validity,
the certificate of verification, accompanied by corresponding calculation notes and 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of the relevant TSI(s) and mentioning any reservations recorded during performance of the activities and not withdrawn; the certificate of verification should also be accompanied by the inspection and audit reports drawn up by the same body in connection with its task, as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 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 to in point (c) of Article 18(4) and in point (c) of Article 21(3), the relevant technical file shall include the assessors' report(s) on the CSMs on risk assessment referred to in Article 6(3) of Directive 2004/49/EC.

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Source: https://www.legislation.gov.uk/eudr/2016/797/annex/IV/division/2/division/2.4 (the official version)
Page: https://openlegislation.uk/eu-directive-2016-797/annex-IV/division-2/division-2.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.