EU Pressure Equipment Directive (PED) Compliance for Pressure Equipment and Assemblies

The Pressure Equipment Directive (PED) 2014/68/EU establishes mandatory safety and conformity requirements for pressure equipment and assemblies placed on the EU market. It applies to vessels, piping, safety accessories, pressure accessories, and assemblies operating above 0.5 bar. The Directive was created to harmonize national laws across Europe, remove technical barriers to trade, and ensure a consistently high level of safety for pressurized equipment. 

For manufacturers, the challenge is that PED applicability is not always obvious at first glance. The Directive does not look at whether a product is marketed as “electrical,” but whether a pressure hazard exists within the equipment. A relatively small internal vessel, piping run, or pressure accessory can be enough to bring an otherwise compliant electrical product into scope, triggering additional classification, documentation, and conformity assessment requirements once the 0.5 bar threshold is exceeded. 

It's one of the most common questions manufacturers ask.

PED applies whenever an system, component or product contains pressure equipment operating above 0.5 bar and does not fall fully under a regulatory exclusion. Typical in-scope products include:

The following products, for example, do not fall within the scope of this Directive:

• Long-distance pipelines,
• Equipment that would fall under category I at most and that is covered by one of the following directives e.g. 2006/42/EC, 2014/33/EU, 2014/35/EU, 93/42/EEC, 2009/142/EC, 2014/34/EU (e.g., hydraulic systems covered by the Machinery Directive or steam-heated devices for sterilizing medical devices covered by the Medical Devices Regulation),
• Bottles and cans for carbonated beverages intended for end use
• enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines.

The complete list of exceptions can be found in Article 1(2) of the EU Pressure Equipment Directive.

In some cases, very low-risk pressure equipment may fall under the PED classification known as Sound Engineering Practice (SEP)

Key points about SEP:

• SEP equipment operates above 0.5 bar but below the Category I threshold
• It must still be designed and manufactured safely
• It does not undergo formal PED conformity assessment and must not bear the CE mark for PED

Determining whether equipment qualifies as SEP or must be CE marked under PED is a critical first step in every compliance project.

Correct classification is the foundation of every PED compliance project, because it determines the level of regulatory scrutiny and whether the involvement of a Notified Body is mandatory.

The first step is fluid group classification. Fluids are legally classified as either

• Group 1: hazardous fluids such as flammable, toxic, or explosive substances.
• Group 2: including all other fluids such as air, water, and inert gases.

Once the fluid group is identified, the equipment is classified using the fluid state (gas or liquid), the type of pressure equipment involved, the maximum allowable pressure (PS), and the volume or nominal size (DN). These parameters are applied to the hazard category charts in Annex II of the Directive to place the equipment into one of five categories: Sound Engineering Practice (SEP). Category I, II, III or IV

This assigned category determines whether the manufacturer may self-certify the equipment or whether the involvement of a Notified Body is legally mandatory.

A Notified Body must be involved for all pressure equipment and assemblies classified as Category II, III or IV. Notified Bodies are independent, EU-designated organizations authorized to perform legally mandated conformity assessment activities under the PED.

These activities may include design examinations, inspections and testing of finished equipment, audits of manufacturing quality systems, unit verification for one-off builds, and formal review of technical documentation.
Where the PED requires the involvement of a Notified Body, CE marking is not legally valid without the appropriate certificate of approval or conformity

Intertek is an EU designated Notified Body for the Pressure Equipment Directive and provides full conformity assessment services across all PED categories.

The PED uses a modular conformity assessment system that offers different approval routes depending on the equipment’s hazard category and the manufacturer's production model. These routes are not merely administrative choices; they represent important business decisions that can significantly affect cost, timelines, and long-term compliance efficiency.

Selecting the most appropriate module early in the project can dramatically streamline PED compliance and avoid unnecessary regulatory burden.

The PED requires that all pressure-retaining materials are suitable, traceable, and demonstrably safe. The most straightforward path to compliance is the use of materials manufactured to harmonized European standards, which benefit from a built-in presumption of conformity.

Many pressure equipment manufacturers, however, rely on global material standards such as ASME or ASTM. These materials can be used under the PED, but they do not receive automatic acceptance. Instead, they require a formal evaluation known as a Particular Material Appraisal, or PMA, which is performed with the involvement of a Notified Body for pressure equipment in categories III and IV to demonstrate equivalent safety to EN-compliant materials and the requirements set out in the ESR´s of PED Annex I.

Establishing a materials strategy early in the project is one of the most effective ways to prevent redesigns, requalification efforts, and costly approval delays.

Pressure equipment is rarely governed by the Pressure Equipment Directive alone. Most products also fall under additional EU legislation that addresses other hazards.

Common directive combinations include:

• The Machinery Directive, which covers mechanical hazards and moving parts
• The Low Voltage Directive (LVD), which addresses electrical safety
• The EMC Directive, which covers electromagnetic compatibility
• The ATEX Directive, for equipment intended for use in potentially explosive atmospheres

How these directives apply depends on the pressure hazard level of the equipment:

• If pressure equipment integrated into a machine is classified as Category I or lower, it may be excluded from PED and covered instead by the Machinery Directive.
• Once the pressure hazard reaches Category II or higher, full PED compliance becomes mandatory in addition to all other applicable directives.

Intertek provides a fully integrated PED compliance solution for manufacturers of electrical and electromechanical equipment. As an Eu designated PED Notified Body with a global engineering and inspection network, Intertek supports every stage of the compliance process, from early classification and materials strategy through welding qualification, conformity assessment, and CE marking.

By combining PED services with support for the Machinery Directive, Low Voltage Directive, EMC Directive, and ATEX Directive, Intertek delivers a true one stop solution for EU market access. This integrated approach shortens approval timelines, reduces regulatory risk, and eliminates the inefficiencies of managing multiple conformity assessment partners.

Whether you manufacture electric boilers, compressor skids, HVAC systems, or complex assemblies, Intertek helps you achieve PED compliance and CE marking with confidence.

Contact us today to speak with a PED expert and begin a streamlined path to EU market access.