Pressure Equipment Directive (PED) - Conformity assessment and CE marking of pressure equipment

   In Danish
If you manufacture pressure equipment such as boilers, pressure vessels, piping, or safety accessories, the Pressure Equipment Directive (PED, 2014/68/EU) requires the equipment to undergo a conformity assessment before it can be CE marked and marketed in the EU.

Depending on the equipment's category and risk profile, it may be a requirement that the assessment is carried out by an independent notified body.

For many manufacturers, the process raises specific questions: Which conformity assessment module is the right one? What must the technical documentation contain? And how do we ensure that our quality management system meets the requirements?

Challenges we often meet among manufacturers of pressure equipment

Manufacturers of pressure equipment often reach out with one or more of these challenges:

• Uncertainty about category and module. It can be unclear which category (I-IV) the equipment falls into, and thus which conformity assessment module is required.
• Documentation is inadequate. Technical documentation, calculations, or material certificates do not live up to the level expected by a notified body.
• The quality management system is immature. The manufacturer wishes to apply Module D (quality assurance of the production process), but is uncertain whether the quality management system meets the requirements.
• New products or design changes. A new product or a change to an existing design requires a new or updated type examination.
• Market surveillance or customer inquiry. An authority or customer has raised questions regarding the documentation, and the manufacturer needs to strengthen the foundation.
• Choice of notified body. The manufacturer has previously used another body and is considering switching, but is uncertain about the process.

Conformity assessment

According to legislation, all pressure equipment is divided into categories I, II, III, and IV. The category depends on, among other things, pressure, temperature, volume, and fluids; the higher the risk associated with the equipment, the higher the category.

• Equipment in categories I-IV must be CE marked*
• Equipment in category I is approved through internal production control and does not require the involvement of a notified body
• Equipment in categories II, III, and IV must be approved with the involvement of a notified body

As a notified body under the Pressure Equipment Directive, Dancert performs conformity assessments of pressure equipment and issues the certificates necessary for CE marking.

What you get out of the collaboration

A conformity assessment is a legal requirement for pressure equipment in the higher categories. But the right partner makes a difference:

• CE marking and market access. You receive the documentation and certificates necessary to legally market your pressure equipment throughout the EU.
• Strengthened documentation. The process often reveals gaps in the technical documentation, which the manufacturer then has the opportunity to close before the product reaches the market.
• Professional sparring. Danish Technological Institute's specialists know both the directive and the relevant harmonized standards and can help you choose the right path to compliance.
• Peace of mind during inspections and market surveillance. With a certificate from a recognized notified body, you stand on stronger ground if an authority asks questions about your product.
• Flexibility in choice of module. We help you select the module that best fits your product type, production method, and quality management system.
• Impartial assessment. Danish Technological Institute is a self-owning, impartial institution with no commercial interest in how the equipment is designed or sold.

Contact us

Do you need help with a conformity assessment or CE marking of pressure equipment? Contact Danish Technological Institute's specialist and center director, Maja Rose Wieland, for an initial discussion about your project.

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