The Pressure Equipment Regulations 1999

Module H1 (full quality assurance with design examination and special surveillance of the final assessment)

1.  In addition to the requirements of module H, the following apply:

(a) the manufacturer must lodge an application for examination of the design with the notified body;

(b) the application must enable the design, manufacture and operation of the pressure equipment to be understood, and enable conformity with the relevant requirements of the Directive to be assessed.

• It must include:

  • the technical design specifications, including standards, which have been applied,

  • the necessary supporting evidence for their adequacy, in particular where the standards referred to in Article 5 have not been applied in full. This supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf;

(c) 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 certificate must contain the conclusions of the examination, the conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the functioning of the pressure equipment or accessories;

(d) the applicant must inform the notified body that has issued the EC design-examination certificate of all modifications to the approved design. 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. This additional approval must be given in the form of an addition to the original EC design-examination certificate;

(e) 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to the other notified bodies the relevant information concerning the EC design-examination certificates it has withdrawn or refused.