CE Certification Processes for Pressure Equipment

CE Certification for Pressure Equipment: Process and Requirements under Directive 2014/68/EU

The European Union’s Pressure Equipment Directive (PED) 2014/68/EU was established to ensure that equipment with a certain internal pressure is safely placed on the market. This directive mandates CE marking, requiring manufacturers to demonstrate that their products meet essential safety requirements.

In this guide, we outline the CE certification process for pressure equipment under Directive 2014/68/EU and explain how SERTİFİKE can assist you in obtaining certification.

Products Covered by the Pressure Equipment Directive

Directive 2014/68/EU applies to equipment that exceeds specific pressure levels and contains gases or liquids. The main products covered include:

• Pressure vessels
• Steam boilers
• Piping systems
• Safety accessories (valves, pressure relief valves, etc.)
• Industrial gas cylinders
• Hydraulic and pneumatic systems

These products are categorized based on operating pressure, internal volume, and the hazard level of the contained fluid, which determines their certification process.

CE Certification Process Under Directive 2014/68/EU

The CE marking process for pressure equipment follows conformity assessment modules based on product risk levels. The process generally consists of the following steps:

1. Determining the Product Category

The product is classified according to operating pressure, internal volume, and the hazard level of the fluid. Under the directive, pressure equipment falls into categories I to IV, with Category IV being the highest risk.

2. Selecting the Appropriate Conformity Assessment Module

Depending on the product’s risk level, different conformity assessment modules apply. The 2014/68/EU Directive defines several assessment methods based on pressure, volume, and fluid hazard level.

The available conformity assessment modules include:

• Module A: Self-declaration of conformity by the manufacturer, without the need for a Notified Body. Applicable to low-risk Category I products.
• Module B: A Notified Body conducts a type examination of the product. This module must be combined with other modules.
• Modules C1 and C2: Used with Module B, requiring manufacturers to perform manufacturing controls and conduct random testing.
• Module D: A quality assurance system for production, combined with Module B, ensuring regular inspections of production processes.
• Module E: A quality assurance system focusing on final inspection and testing of the product.
• Module F: Batch or individual product testing to verify compliance during production.
• Module G: Direct individual product verification by a Notified Body. Used for high-risk equipment.
• Modules H and H1: Cover full quality assurance, requiring manufacturers to establish a quality management system under continuous Notified Body supervision. Module H1 also includes design examination.

Selecting the correct module is critical for a smooth certification process. SERTİFİKE helps you determine the correct conformity assessment module and ensures all necessary steps are completed accurately.

3. Testing & Technical Documentation Preparation

A technical file is prepared to demonstrate compliance with safety requirements. This includes:

• Pressure tests
• Material strength assessments
• Leakage tests

4. Collaboration with a Notified Body (For Higher Categories)

For Category II, III, and IV equipment, a Notified Body must be involved in the certification process. SERTİFİKE collaborates with authorized Notified Bodies to ensure a seamless certification experience.

5. Affixing the CE Mark

Once all requirements are met, the manufacturer affixes the CE mark on the product and issues a Declaration of Conformity.

Why Choose SERTİFİKE for CE Certification?

At SERTİFİKE, we provide comprehensive support to manufacturers in obtaining CE certification for pressure equipment:

✅ Accurate Product Classification – Ensuring correct category determination for a smooth certification process.
✅ Technical Documentation Preparation – Assisting with test reports, risk analyses, manufacturing processes, and declarations of conformity.
✅ Collaboration with Notified Bodies – Partnering with authorized bodies to expedite the certification process.
✅ Testing & Compliance Support – Ensuring compliance with regulatory testing requirements through accredited laboratories.
✅ Complete CE Marking Process – Managing all certification steps to facilitate market entry in Europe.

Can Pressure Equipment Be Sold Without a CE Mark?

Pressure equipment covered by Directive 2014/68/EU cannot be sold in the EU or Turkey without CE marking. Products without CE certification are subject to market surveillance inspections, which can lead to severe penalties or sales bans.

Manufacturers must ensure regulatory compliance and obtain a CE certificate before placing their products on the market. SERTİFİKE is here to help you complete this process efficiently and reliably.