OpenLegislation

Annex I

United Kingdom

Original text. Later amendments are not shown.

ANNEX V

“EC” DECLARATION OF VERIFICATION OF SUBSYSTEMS

1.

“EC” DECLARATION OF VERIFICATION OF SUBSYSTEMS

The “EC” declaration of verification of a subsystem is a declaration established by the “applicant” within the meaning of Article 18 in which he declares on his sole responsibility that the subsystem concerned, which has been subject to the relevant verifications procedures, satisfies the requirements of the relevant Union legislation, including any relevant national rules.

The “EC” declaration of verification and the accompanying documents must be dated and signed.

The “EC” declaration of verification must be based on the information resulting from the “EC” verification procedure for subsystems set out in Annex VI. It must be written in the same language as the technical file accompanying the “EC” declaration of verification and must contain at least the following:

  1. (a)

    the reference to this Directive, TSIs and applicable national rules,

  2. (b)

    the reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure and to the national rules which have been applied in case of a derogation, partial application of TSIs for upgrade or renewal, transitional period in a TSI or specific case,

  3. (c)

    name and address of the “applicant” within the meaning of Article 18 (specifying the trade name and full address; in the case of the authorised representative, specifying also the trade name of the contracting entity or the manufacturer),

  4. (d)

    a brief description of the subsystem,

  5. (e)

    name(s) and address(es) and the identification number(s) of the notified body(ies) which conducted the “EC” verification(s) referred to in Article 18,

  6. (f)

    name(s) and address(es) and the identification number(s) of the notified body(ies) which conducted the assessment of conformity with other regulations deriving from the Treaty,

  7. (g)

    name(s) and address(es) of the designated body(ies) which conducted the verification(s) of conformity with national rules referred to in Article 17(3),

  8. (h)

    name and address of the assessment body(ies) which established the safety assessment reports related to the use of the CSM on risk assessment where required by this Directive,

  9. (i)

    the references of the documents contained in the technical file accompanying the “EC” declaration of verification,

  10. (j)

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

  11. (k)

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

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

2.

“EC” DECLARATION OF VERIFICATION OF SUBSYSTEMS IN THE CASE OF MODIFICATIONS

In a case of a modification, which is not a substitution in the framework of maintenance, of a subsystem covered by an “EC” declaration of verification, without prejudice to Article 20, the following provisions apply.

2.1.

If the entity introducing the modification 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:

  1. (a)

    the entity introducing the modification shall update the references of the documents contained in the technical file accompanying the “EC” declaration of verification;

  2. (b)

    no new “EC” declaration of verification needs to be established.

2.2.

If the entity introducing the modification demonstrates that the modification affects the basic design characteristics of the subsystem which are relevant for the compliance with the requirements concerning some basic parameters:

  1. (a)

    the entity introducing the modification shall establish a complementary “EC” declaration of verification with reference to the basic parameters concerned;

  2. (b)

    the complementary “EC” declaration of verification shall be accompanied by a list of documents of the original technical file accompanying the original “EC” declaration of verification that are no more valid;

  3. (c)

    the technical file accompanying the “EC” declaration of verification shall include a demonstration that the impact of modifications is limited to the basic parameters referred to in point (a);

  4. (d)

    provisions of Section 1 of this Annex shall apply mutatis mutandis to this complementary “EC” declaration of verification;

  5. (e)

    the original “EC” declaration of verification shall be considered valid for the basic parameters not concerned by the modification.

3.

“EC” DECLARATION OF VERIFICATION OF SUBSYSTEMS IN THE CASE OF ADDITIONAL VERIFICATIONS

An “EC” declaration of verification of a subsystem may be complemented in the case of additional verifications carried out, in particular when such additional verifications are necessary for an additional authorisation for placing in service. In this case the scope of the complementary declaration shall be limited to the scope of the additional verifications.