Until 30 September 2004, Member States shall accept the placing on the market and the putting into service of medical devices referred to in Article 1(1) which are covered by an EC design-examination certificate or an EC type-examination certificate issued before 1 April 2004.

The notified body must examine the application and, if the product conforms to the relevant provisions of this Directive, issue the application with an EC design-examination certificate.

Changes to the approved design must receive further approval from the notified body which issued the EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product.

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

EC type-examination shall not be required in the case of PPE models of simple design where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerned the effects of which, when they are gradual, can be safely identified by the user in good time.

These batches shall be accompanied by the EC type-examination certificate referred to in Article 10, or, where the vessels are not manufactured in accordance with an approved prototype, by the design and manufacturing schedule referred to in Annex II section 3. In this case the approved body shall, prior to EC verification, examine the schedule in order to certify its conformity.,

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 in points 4.4 and 4.5, with a notified body of its choice.

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.

EC verification is the procedure whereby a manufacturer or his authorized representative established within the Community ensures and declares that the vessels which have been checked in accordance with paragraph 3 are in conformity to the type described in the EC type-examination certificate or with the design and manufacturing schedule referred to in Annex II section 3 having received a certificate of adequacy.

Where the subsystem meets the requirements of Directive 96/48/EC and of 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.

If the authority or the inspector considers that deficiencies in the maintenance of a commercial vehicle may represent a safety risk such that, as regards the brakes in particular, further examination is justified, the commercial vehicle may be subjected to a more elaborate test at a testing centre in the vicinity, designated by the Member State, in accordance with Article 2 of Directive 96/96/EC.

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 Directive 96/48/EC and of the TSI that apply to it.

The manufacturer shall take all the necessary measures for the manufacturing process to ensure that the vessels conform to the type described in the EC type-examination certificate or to the design and manufacturing schedule referred to in Annex II section 3- The manufacturer or his authorized representative established within the Community shall affix the CE marking to each vessel and draw up a declaration of conformity.

Whereas Article 2(1) of Commission Regulation (EC) No 577/97 of 1 April 1997 laying down certain detailed rules for the application of Council Regulation (EC) No 2991/94 laying down standards for spreadable fats and of Council Regulation (EEC) No 1898/87 on the protection of designations used in the marketing of milk and milk products (3), as last amended by Regulation (EEC) No 1298/98 (4), lays down the rules concerning indication of the fat content of spreadable fats with the exception of the products referred to in Regulation (EC) No 2991/94 having a minimum fat content of 80 %; whereas a method for verifying compliance with those rules is laid down in Article 2(3) of Regulation (EC) No 577/97 and in Annex II thereto; whereas the date of application of that method has been deferred to 1 January 1999 in order to allow users to gain experience with it and, on the basis of results forwarded to the Commission, to allow a thorough examination of its viability;

(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 and

if Module H2 is required in the TSI, an EC design examination certificate.

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

where appropriate, a reference to the EC type-examination certificate, EC design-examination certificate or EC certificate of conformity,

the technical documentation for the approved type and a copy of the EC type-examination certificate or EC design-examination certificate.

The 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 modification made to the approved design.

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

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

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

This supplementary approval shall be given in the form of an addendum to the EC design examination certificate.

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

Such additional approval must be 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 applicant must inform the notified body that holds the technical documentation concerning the EC design-examination certificate of all modifications to the approved design;

The notified body shall examine the application and, if the design conforms to the relevant provisions of this Directive shall issue the applicant with an EC design-examination certificate.

The quality system must ensure compliance of the pressure equipment with the type described in the EC type-examination certificate or EC design-examination certificate and with the requirements of the Directive which apply to it.

The notified body must examine the application and where the design complies with those provisions of the international instruments that apply it must issue an EC design-examination certificate to the applicant.

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

When the design is not entirely in accordance with harmonized standards, the notified body must ascertain whether the design conforms to the provisions of the Directive and, if it does, issue an 'EC design examination certificate' to the installer, stating the limits of the certificate's validity and giving the details required for identification of the approved design.

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.

The notified body must examine the application and, if the device conforms to the relevant provisions of the Directive, issue the application with an EC design-examination certificate.

The notified body shall examine the application and, where the product complies with the relevant provisions of this Directive, shall issue the applicant with an EC design examination certificate.

Changes to the approved design must receive further approval from the notified body which issued the EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the device.

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 essential requirements of the Directive or the prescribed conditions for use of the 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 compliance with the relevant requirements of the international instruments or the prescribed conditions for use of the product.

Modifications made to the approved design must obtain supplementary approval from the notified body which issued the EC design examination certificate where such modifications may affect conformity with the essential requirements of this Directive or the conditions prescribed for the use of the product.

This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the pressure equipment concerned is in conformity with the type described in the EC type-examination certificate or EC design-examination certificate and satisfies the requirements of the Directive which apply to it.

If the notified body refuses to issue an EC design-examination certificate to the manufacturer or to his authorized representative established within the Community, that body must provide detailed reasons for such refusal. Provision must be made for an appeals procedure.

Module C is designed to be used in combination with module B (EC type-examination).

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

Exceptionally, assemblies intended for generating warm water as referred to in Article 3, Section 2.3, must be subject either to an EC design examination (Module B1) with respect to their conformity with the essential requirements referred to in Sections 2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I, or to full quality assurance (Module H).

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;