In order to determine whether the metrological properties of the meters manufactured and presented for initial verification conform to the requirements of this Directive, an examination for conformity to the approved type may be carried out at intervals determined by the competent metrological authority, on three meters chosen at random after the acceptance tests.

MODULE SB (EC Type-examination)

the type-examination certificate and its additions.

documentation relating to the approved type and a copy of the EC type-examination certificate.

the EC type-examination as referred to in section 1 of Annex II, and

the documentation relating to the approved type and a copy of the EC type-examination certificate.

the technical documentation of the approved type and a copy of the type-examination certificate, issued after the completion of the type-examination procedure of module SB.

the technical documents pertaining to the approved type and a copy of the EC type-examination certificate.

where appropriate, the type-examination certificate referred to in Annex III.

follow the procedure relating to the EC type-examination set out in Annex III, coupled with:

where appropriate, reference to the EC type-examination certificate issued by a notified body,

Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate.

where appropriate, the technical documentation of the approved type (see Annex XIII) and a copy of the EC type-examination certificate.

Where the type meets the provisions of the Directive, the notified body shall issue an EC type-examination certificate to the applicant.

If the type conforms to the provisions of this Directive, the notified body issues the applicant with an EC type-examination certificate.

Where the type satisfies the provisions of this Directive, the notified body must issue an EC type-examination certificate to the applicant.

Where the type meets the relevant provisions of this Directive, the notified body issues an EC type-examination certificate to the applicant.

Other notified bodies may obtain a copy of the EC type-examination certificates and/or the addenda to them.

EC type examination (Module B) referred to in Annex II (1), and, at the choice of the manufacturer, either:

Where the type meets the provisions of Directive 96/48/EC and of the TSI, the notified body must issue a type-examination certificate to the applicant.

The other notified bodies may receive copies of the EC type-examination certificates and/or their additions.

Holders of EC design-examination certificates or EC type-examination certificates issued before 1 April 2004 for medical devices referred to in Article 1(1) shall apply for a complementary EC design-examination certificate or EC type-examination certificate attesting to compliance with the specifications laid down in the Annex to this Directive.

This additional approval is given in the form of an addition to the original EC type-examination certificate.

Other notified bodies may obtain a copy of the EC type-examination certificates and/or the supplements thereto.

It is necessary to provide for an adequate transitional period for medical devices already covered by an EC design-examination certificate or by an EC type examination certificate.

the EC type-examination (module B) referred to in Annex VII followed by module C (type conformity) referred to in Annex VIII, or any of the following modules:

This additional approval is to be given in the form of an addition to the original EC type-examination certificate.

the EC type-examination (module B) referred to in Annex VII supplemented by module C (type conformity) referred to in Annex VIII, or any of the following modules:

This new approval must, where appropriate, take the form of a supplement to the initial EC type-examination certificate.

where appropriate, the technical documentation on the types approved and a copy of the EC type-examination certificates,

The other notified bodies may receive copies of the type-examination certificates issued and/or their additions on request.

the appliances or the fittings do not conform to the appliance or fitting as referred to in the EG type-examination certificate,

An inspection body withdrawing an EC type-examination certificate shall inform the Member State which approved it, to this effect.

The notified body must inform the other notified bodies forthwith of the issuing of the EC type-examination certificate and any additions to the said type as referred to in point 1.7.

The quality system must ensure conformity of explosives with the type as described in the EC type-examination certificate and with the requirements of this Directive that apply to them.

The quality system shall ensure compliance of the products with the type as described in the EC type-examination certificate and with the requirements of the Directive that apply to them.

Any inspection body which refuses to issue an EC type-examination certificate shall inform the other approved inspection bodies of this fact.

If no type tests are requested within the type-examination procedure (see point 4. 4), and the type is sufficiently defined by the technical documentation, as described in point 3, the notified body may agree, that no specimens are placed at their disposal.

The inspection body of which notification has been given shall conduct the EC type-examination in accordance with the undermentioned procedures:

the type-examination procedure (module SB) indicated in Annex III (III.2) to this TSI, for the design and development phase, in combination with:

The applicant must keep the notified body that has issued the EC type-examination certificate informed of all modifications to the approved type which might affect conformity with the essential requirements.

The applicant must inform the notified body which issued the EC type-examination certificate of any significant change made to the approved product.

the technical documentation regarding the approved type, including the type-examination certificate, as issued after completion of the procedure defined in module SB, and, if not included in this documentation,

The manufacturer shall apply a quality system that ensures conformity of the appliances with the type as described in the EC type-examination certificate and with the essential requirements of this Directive which apply to them.

If the model satisfies the relevant provisions, the inspection body shall draw up an EC type-examination certificate and shall notify the applicant to this effect.

This module describes the procedure whereby the manufacturer who satisfies the obligations of Section 2 ensures and declares that the explosives are in conformity with the type as described in the EC type-examination certificate.

The EC declaration of conformity to type is that part of the procedure whereby the manufacturer declares that the appliances concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the essential requirements of this Directive which apply to them.

Before issuing an EC design-examination certificate or an EC type-examination certificate, the notified bodies shall give due consideration to any comments received within 12 weeks from the date on which the opinion of the national competent authorities was sought.

The application for type-examination must be lodged by the manufacturer or his authorized representative established within the Community with a single notified body.

The application for EC type-examination is lodged by the manufacturer or his authorized representative established within the Community with a notified body of his choice.