Module B1 (EC design examination)

in the EC design-examination certificate,

number of the EC-type examination certificate or the EC design examination certificate;

the EC design examination certificates and additions issued,

the EC design-examination certificates and additions granted,

the EC design examination certificates and additions refused.

the EC design-examination certificates and additions withdrawn.

the EC-type examination certificates or EC design examination certificates in respect of instruments containing parts identical to those in the design.

the applicant must inform the notified body that has issued the EC design-examination certificate of all modifications to the approved design.

The applicant must keep the notified body that issued the EC design examination certificate informed of any modification to the approved design.

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

This additional approval must be given in the form of an addition to the original EC design-examination certificate;

The notified body must examine the application and where the design meets the provisions of this Directive, must issue an EC design examination certificate to the applicant.

In Annex IV Part I, in module D, point 1, first sentence, point 3.1, second subparagraph, third indent and point 3.2, first subparagraph, the words "EC type-examination certificate" are replaced by the words "EC type-examination certificate or EC design-examination certificate".

the notified body must examine the application and where the design meets the provisions of the Directive which apply to it issue an EC design-examination certificate to the applicant.

The manufacturer, or his authorised representative established within the Community, must lodge an application for EC design examination with a single notified body.

each notified body must also communicate to the other notified bodies the relevant information concerning the EC design-examination certificates it has withdrawn or refused.

Each notified body must communicate to the Member States the relevant information concerning EC design-examination certificates which it has withdrawn, and, on request, those it has issued.

Modifications to the approved design must receive additional approval from the notified body that issued the EC design-examination certificate where they may affect conformity with the requirements of the Directive or the prescribed conditions for use of the transportable pressure equipment.

Modifications to the approved design must receive additional approval from the notified body that issued the EC design examination certificate where such changes may affect conformity to the essential requirements referred to in Article 3(1) of this Directive or the prescribed conditions for use of the component.

The manufacturer, or his authorised representative established within the Community, must keep with the technical documentation referred to in point 3 copies of EC design-examination certificates and their additions for a period of 10 years after the last of the transportable pressure equipment has been manufactured.

The notified body must examine the application concerning the design examination and where the design meets the provisions of Directive 96/48/EC and of the TSI that apply to it must issue a design examination report to the applicant.

EC-type examination and design examination certificates and their annexes issued by notified bodies as well as additions, amendments and withdrawals relating to certificates already issued;

Where the design meets the provisions of the Directive which apply to it, the notified body must issue an EC type-examination certificate to the applicant.

The applicant must inform the notified body that holds the technical documentation concerning the EC type-examination certificate of all modifications to the approved design;

The adjudicating entity or its authorised representative established within the Community must lodge an application for EC verification of the subsystem (through full quality assurance with design examination), including coordination of surveillance of the quality systems as under points 4.4 and 4.5, with a notified body of its choice.

Where the subsystem meets the requirements of Directive 96/48/EC and the TSI, the notified body must then, based on the design examination and the approval and surveillance of the quality system(s), draw up the certificate of EC verification intended for the adjudicating entity or its authorised representative established within the Community, which in turn draws up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.

This module describes the procedure whereby a notified body carries out an examination of the design of an interoperability constituent and the manufacturer or his authorised representative established within the Community who satisfies the obligations of point 2, ensures and declares that the interoperability constituent concerned satisfies the requirements of the Directive 96/48/EC and of the TSI that apply to it.

This additional approval must take the form of a supplement to the EC design-examination certificate.

The applicant shall inform the notified body which issued the EC design-examination certificate of any such changes made to the approved design.

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.

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.

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.