What does the conformity assessment procedure under Category II Module A2 include?

Technical Documentation

Technical documentation prepared by the manufacturer shall enable the assessment of the conformity of the pressure equipment with the relevant requirements and must include a suitable risk analysis and assessment. The technical documentation must list the applicable requirements and, as far as necessary for the assessment, capture the design, manufacture, and operation of the pressure equipment. The technical documentation shall contain at least the following elements:

• a general description of the pressure equipment;
• designs, manufacturing drawings and plans of components, subassemblies, circuits, etc.;
• descriptions and explanations necessary for understanding these drawings and plans as well as the functioning of the pressure equipment;
• a list of which harmonized standards have been applied in full or in part, and a description of how the essential safety requirements of this directive have been met in areas where these harmonized standards have not been applied; in the case of partially applied harmonized standards, these parts shall be specified in the technical documentation;
• the results of design calculations, tests, etc.;
• the test reports.

Manufacturing

The manufacturer must take all necessary measures to ensure that the manufacturing process and its supervision guarantee that the manufactured pressure equipment complies with the technical documentation and the requirements of this directive.

Acceptance and Pressure Equipment Tests

The manufacturer conducts an acceptance of the pressure equipment, monitored in the form of unannounced visits by the chosen notified body of the manufacturer.
The notified body conducts product tests at irregular intervals defined by them to verify the quality of the internal pressure equipment tests. In doing so, they take into account the technical complexity of the pressure equipment and the production volume.

During these visits, the notified body must:

• ensure that the manufacturer actually performs the acceptance according to Annex I number 3.2 of the Pressure Equipment Directive;
• remove pressure equipment from the manufacturing or storage premises for control purposes. The notified body decides on the number and whether, if necessary, the acceptance should be conducted in whole or in part.

This sampling procedure aims to determine whether the manufacturing process of the pressure equipment is within acceptable limits to ensure the conformity of the pressure equipment.
In case of non-conformity of one or more pressure equipment, the notified body takes appropriate measures.

The manufacturer affixes the identification number of the notified body under their responsibility during the manufacturing process.

CE Marking and EU Declaration of Conformity:

• The manufacturer affixes the CE marking to each individual pressure equipment that meets the applicable requirements of this directive.
• The manufacturer issues a written EU declaration of conformity for a model of the pressure equipment and keeps it together with the technical documentation for national authorities for ten years after the pressure equipment has been placed on the market. The EU declaration of conformity must clearly indicate for which pressure equipment it was issued.

A copy of the EU declaration of conformity shall be made available to the competent authorities upon request.

The EU declaration of conformity must contain the following information:

1. Pressure equipment or assembly (product, type, batch, or serial number)
2. Name and address of the manufacturer and, if applicable, their authorized representative
3. The sole responsibility for the issuance of this declaration of conformity lies with the manufacturer
4. Subject of the declaration (designation of the pressure equipment or assembly for traceability purposes; it may include a picture, if necessary, for the identification of the pressure equipment or assembly):
   1. Description of the pressure equipment or assembly;
   2. applied conformity assessment procedures;
   3. for assemblies, description of the pressure equipment from which the assembly consists, as well as the applied conformity assessment procedures.
5. The subject of the declaration described above meets the relevant harmonization legislation of the European Union:
6. Indication of the relevant harmonized standards that have been applied, or indication of other technical specifications for which conformity is declared:
7. If applicable, name, address, and number of the notified body that carried out the conformity assessment, number of the issued certificate, and reference to the EU type examination certificate (type), the EU prototype examination certificate, the EU design examination certificate, or the declaration of conformity.
8. Additional information:

• Signed for and on behalf of:
• (Place and date of issue)
• (Name, position) (Signature)
• (If applicable: details of the signatory authorized to sign the declaration on behalf of the manufacturer or their authorized representative)