PED (CE) Certification

The Pressure Equipment Directive (PED — 2014/68/EU) governs the design, manufacture and conformity assessment of pressure equipment and assemblies with an allowable maximum pressure exceeding 0.5 bar. Equipment is divided into categories I to IV by the fluid's hazard group (Group 1 hazardous, Group 2 other), the equipment type (vessel, piping, safety accessory, pressure accessory) and the pressure-volume product; the notified body's role grows as the category rises.

• Manufacturers of pressure vessels, boilers and steam generators
• Manufacturers of pressure piping and manifolds
• Manufacturers of safety valves and rupture discs
• Manufacturers of heat exchangers and autoclaves
• Firms assembling pressure equipment and placing assemblies on the market

Mandatory for equipment within scope. In Category I the manufacturer can self-declare; a notified body is involved in Categories II, III and IV, and as the category rises, the approval of permanent-joining and non-destructive-testing personnel is also carried out by a notified body or a recognised third-party body. Low-risk equipment under article 4(3) does not carry the CE mark; it is manufactured to sound engineering practice.

• Scope, fluid grouping and category-determination tables (Annex II)
• Essential safety requirements (Annex I): design, manufacture, material
• Design: resistance to pressure, stability, safe filling and venting, fire precautions
• Material requirements and European approval of materials
• Approval of permanent-joining (welding) procedures and personnel
• Qualification of non-destructive-testing personnel
• Final assessment: final inspection, a proof test (hydrostatic test), examination of the safety devices
• Marking and instructions for use
• Conformity-assessment modules (Annex III) and their selection by category
• Assessment of assemblies as a whole

1. 1Determining the LegislationIt is determined which EU legislation applies to the product. A product can fall within scope of more than one piece of legislation at the same time; all of them must be met.
2. 2Selecting the Conformity Assessment ModuleThe legislation determines the module to follow according to the product's risk class. The manufacturer self-declares under some modules, while a notified body is involved under others.
3. 3Testing Against Harmonised StandardsConformity with harmonised standards published in the EU Official Journal is demonstrated through testing; this provides a presumption of conformity with the legislation.
4. 4Risk Analysis and the Technical FileThe risk assessment, design calculations, test reports, instructions for use and sample labels are compiled in the technical file.
5. 5The EU Declaration of ConformityThe manufacturer or its EU-based authorised representative signs the declaration of conformity. Responsibility rests with the signatory of the declaration.
6. 6Affixing the CE MarkThe mark is affixed to the product in the form and size the legislation prescribes; the notified body's identification number is added if one is involved.
7. 7Retaining the Technical FileThe technical file is retained for the period the legislation sets from the product's placing on the market (10 years under most legislation) and presented to the competent authority on request.

The CE mark is not a certificate but the manufacturer's declaration of conformity, and it has no expiry. However, the declaration remains valid as long as the product and the legislation do not change: the technical file must be updated if the legislation or the harmonised standard is updated. Notified-body certificates (e.g. an EU Type-Examination Certificate) are subject to a validity period.

• The product description, model list and technical drawings
• Risk assessment
• The list of harmonised standards applied
• Test reports
• Instructions for use and warning labels (in the target market's language)
• A draft EU Declaration of Conformity
• Design calculations and the strength calculation
• Manufacturing and assembly drawings
• Material certificates (EN 10204 3.1 / 3.2)
• The welding procedure specification (WPS) and its approval (WPQR), and welder certificates
• The non-destructive-testing plan, personnel certificates and reports
• The hydrostatic test report
• Set-point and capacity calculations for the safety accessories
• Instructions for use and the equipment rating plate

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of pieces of legislation applicable to the product
• The conformity-assessment module — whether a notified body is involved
• The required test scope and number of samples
• The current state of the technical file
• Translation and documentation needs

A Notified Body under CE is registered in the European Commission's NANDO database for the relevant EU regulation and carries a four-digit identification number. Notified body authority is based on legislation and product scope; The authority granted for one regulation does not extend to another. Testing is within the scope of ISO/IEC 17025, product certification is within the scope of ISO/IEC 17065.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• CESPVD
• CEATEX
• CEGas Appliances
• CEMachinery Safety
• CELVD
• CEEMC
• CERED
• CEMDR