The Railways (Interoperability) Regulations 2011

Regulation 7(2)

[F1 SCHEDULE 5 U.K. UK declaration of verification of subsystems

Textual Amendments

F1 Sch. 5 inserted (31.12.2020) by The Railways (Interoperability) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/345), reg. 1(2), Sch. 4 (as amended by The Railways (Miscellaneous Amendments, Revocations and Transitional Provisions) (EU Exit) Regulations 2020 (S.I. 2020/786), regs. 1(2)(b)(i), 4(10)); 2020 c. 1, Sch. 5 para. 1(1)

(This Schedule substantially reproduces Annex V to the Directive with amendments to correct deficiencies arising from the UK’s withdrawal from the European Union.) U.K.

1.   UK declaration of verification of subsystems U.K.

The UK declaration of verification of subsystems is a declaration established by the project entity applying for an authorisation under these Regulations in which they declare on their sole responsibility that the subsystem concerned, which has been subject to the relevant verification procedures, satisfies the requirements of these Regulations, and any NTSNs or relevant NTRs.

The UK declaration of verification and accompanying documents must be dated and signed.

The UK declaration of verification must be based on the information resulting from the UK verification procedure for subsystems set out in Schedule 4. It must contain at least the following:

(a) the reference to these Regulations, NTSNs and applicable NTRs,

(b) the reference to the NTSN(s) or their parts to which conformity has not been examined during the UK verification procedure and to the UK specific rules which have been applied in the case of an exemption, partial application of NTSNs for upgrade or renewal, transitional period in an NTSN or UK specific case,

(c) name and address of the project entity applying for an authorisation under these Regulations (specifying the trade name and full address; in the case of the authorised representative, specifying also the trade name of the contracting entity or manufacturer),

(d) a brief description of the subsystem,

(e) name(s) and address(es) and the identification number(s) of the approved body or bodies which conducted the UK verification assessment procedure,

(f) if applicable, name(s) and address(es) and identification number(s) of the EU notified body or bodies which conducted the EC verification assessment procedure,

(g) name(s) and address(es) and the identification number(s) of the body or bodies which conducted an assessment of conformity with any other applicable enactment or rule of law,

(h) name(s) and address(es) of the designated body or bodies which conducted the UK verification assessment procedure in relation to UK specific rules,

(i) name and address of the assessment body or bodies which established the safety assessment reports related to the use of the CSM on risk assessment referred to in paragraph 2.4(e) of Schedule 4,

(j) the references of the documents contained in the technical file accompanying the UK declaration of verification,

(k) all the relevant temporary or final provisions to be complied with by the subsystems and in particular, where appropriate, any operating restrictions or conditions,

(l) the identity of the signatory (i.e. the physical person or persons authorised to sign the declaration).

Where reference is made in Schedule 4 to the “intermediate statement of verification” (ISV), the provisions of this Section shall apply to that declaration.

2.   Modification of subsystems with EC or UK declaration of verification issued before IP completion day U.K.

In a case of a modification, which is not a substitution in the framework of maintenance, of a subsystem covered by a UK declaration of verification, or by an EC declaration of verification issued before IP completion day, without prejudice to regulations 12 and 13, the following provisions apply.

2.1.   If the entity introducing the modifications demonstrates that the modification does not affect the basic design characteristics of the subsystem which are relevant for the compliance with the requirements concerning the basic parameters: U.K.

(a) the entity introducing the modification shall update the references of the documents contained in the technical file accompanying the EC or UK declaration of verification, and

(b) no new UK declaration of verification needs to be established.

2.2.   If the entity introducing the modification demonstrates that the modification affects the basic design characteristic of the subsystem which are relevant for the compliance with the requirements concerning some basic parameters: U.K.

(a) the entity introducing the modification shall establish an additional UK declaration of verification with reference to the basic parameters concerned,

(b) the additional UK declaration of verification shall be accompanied by a list of documents of the original technical file accompanying the original UK declaration of verification or EC declaration of verification that are no longer valid,

(c) the technical file accompanying the additional UK declaration of verification shall include a demonstration that the impact of modifications is limited to the basic parameters referred to in point (a),

(d) the provisions of Section 1 of this Schedule shall apply mutatis mutandis to this additional UK declaration of verification,

(e) the original UK declaration of verification or EC declaration of verification shall be considered valid for the basic parameters not concerned by the modification.

3.   UK declaration of verification in the case of additional verifications U.K.

Where additional UK verifications are carried out an additional UK declaration of verification may be required, in particular when such additional verifications are necessary for an additional authorisation for placing in service. In this case the scope of the additional UK declaration of verification shall be limited to the scope of the additional verifications.]