Mapping of PED 2014/68/EU

1. Product qualification – Is the product actually within the scope of the Directive 2014/68/EU?

2. Classification – Determination of the applicable PED category

   Before conformity assessment, pressure equipment and relevant assemblies must be assigned to one of the PED Categories I to IV. This risk-based classification depends on the stored pressure energy and the type of fluid involved and forms the basis for selecting the applicable conformity assessment procedure.

3. Selection of the conformity assessment procedure – Internal Control, Type Examination, Quality Assurance or Unit Verification.

4. Risk assessment – Identification of relevant requirements listed in Annex I – Which essential requirements apply to the product?

5. Assessment of harmonised standards and, where necessary, other means of fulfilment where such standards are not applied or do not exist – Which standards cover the requirements, and where are there gaps?

6. Technical documentation – Which records demonstrate compliance?

7. Information and marking obligations

8. Series Production – How is ongoing conformity ensured?

   Conformity is not limited to design and initial assessment; it must also be maintained throughout ongoing production. In practice, this means identifying and controlling those product and process characteristics whose deviation could compromise compliance with the essential requirements.

9. EU Declaration of Conformity & CE marking – Official confirmation of compliance, ready for the EU market.

This diagram illustrates the SAL workflow visually:

Product qualification

↓

Classification

↓

Conformity assessment procedure

↓

Identification of relevant requirements listed in Annex I

↓

Harmonised standards / other means of fulfilment

↓

Technical documentation

↓

Information and marking obligations

↓

Series Production

↓

CE marking & Declaration of Conformity

Interfaces to Related Legislation

When applying PED 2014/68/EU, there are often intersections with other regulatory frameworks that must be considered simultaneously:

• Machinery Directive and Regulation (2006/42/EC - (EU) 2023/1230)

• GPSR – General Product Safety Regulation ((EU) 2023/988)

A coordinated assessment is therefore necessary to avoid regulatory gaps or duplicated evaluations. In practice, this means SAL provides the roadmap, but it must always be applied in the context of related legislation, including machinery and other applicable directives.

Overview: Directive 2014/68/EU

• Number: 2014/68/EU

• Title: Directive relating to the making available on the market of pressure equipment

• Publication: OJ L 189, 27.6.2014, p. 164

• Purpose: Pressure vessels, piping, safety accessories, and pressure accessories placed on the EU market are subject to specific requirements regarding their design, manufacture, and conformity assessment. These obligations apply only to equipment with a maximum allowable pressure exceeding 0.5 bar.

• Public interest: Protection from pressure-related risks to safety

• Guidance: European Commission’s guidelines: Guidelines related to the Pressure Equipment Directive 2014/68/EU (PED)

Scope

The provisions of the Directive apply to pressure equipment and assemblies with a maximum allowable pressure exceeding 0.5 bar. The term pressure equipment encompasses vessels, piping, safety accessories, and pressure accessories. Where relevant, it also includes components attached to pressurised parts, such as flanges, nozzles, couplings, supports, and lifting lugs.

Certain products listed in Article 1(2) fall outside the scope of the Directive. Examples include simple pressure vessels, aerosol dispensers, equipment intended for vehicle operation, machinery, lifts, and electrical equipment designed for use within specified voltage limits.

Classification

Article 13 establishes how pressure equipment is classified into risk categories. This classification determines the level of regulatory control, conformity assessment, and safety requirements that apply.

Categorisation Based on Hazard Level

Pressure equipment covered by the Directive must be classified into Categories I to IV in accordance with Annex II, reflecting an increasing level of risk:

• Category I → lowest hazard

• Category IV → highest hazard (most stringent controls)

The classification depends on parameters such as:

• Maximum allowable pressure (PS)

• Volume or nominal size (DN)

• Type of equipment (e.g. vessel, piping, etc.)

• Hazardous properties of the contained fluid

Division of Fluids into Two Groups

To assess risk, fluids are divided into two groups:

Group 1 — Hazardous Fluids

These include substances or mixtures classified as dangerous due to physical or safety hazards, such as:

• Explosive substances

• Flammable gases, liquids, or solids

• Oxidising substances

• Self-reactive or pyrophoric materials

• Substances emitting flammable gas on contact with water

• Highly toxic substances (acute toxicity)

• Substances causing specific target organ toxicity

Important:

Fluids are also treated as Group 1 if the equipment’s maximum allowable temperature (TS) exceeds the fluid’s flashpoint, since this significantly increases operational risk.

Group 2 — Non-Hazardous Fluids

All fluids not falling under Group 1 are assigned to Group 2

(e.g. water, air, many inert gases).

Special Rule for Multi-Chamber Vessels

If a vessel consists of several chambers:

• The highest applicable category among the chambers governs the classification.

• If a chamber contains multiple fluids, classification is based on the fluid presenting the greatest hazard.

Conformity Assessment Procedures

Article 14 defines how manufacturers must demonstrate that pressure equipment complies with the Directive before it can be placed on the market or put into service.

Procedures Depend on the Risk Category

The applicable conformity assessment procedure is determined by the category of the equipment (I–IV) established under Article 13.

Higher-risk equipment requires more rigorous third-party involvement.

Assessment Modules by Category

The Directive assigns specific conformity assessment “modules” (described in Annex III) to each category:

• Category I:

  Module A (internal production control; lowest level of external oversight)

• Category II:

  Modules A2, D1, or E1 (increased surveillance, including notified body involvement)

• Category III:

  Multiple combinations such as B + D, B + F, B + E, B + C2, or Module H (type examination plus production quality assurance or product verification)

• Category IV (highest risk):

  B + D, B + F, Module G, or Module H1 (full quality assurance or unit verification with strong notified-body control)

Assemblies (Multiple Equipment Combined)

Assemblies must undergo a global conformity assessment that includes:

• Assessment of each constituent item (if not already CE-marked),

• Verification of their safe integration,

• Evaluation of protection against exceeding allowable operating limits.

The highest applicable risk category within the assembly governs the assessment depth.

Essential Requirements under Annex I

Pressure equipment and assemblies must satisfy the essential safety requirements set out in Annex I to the Directive. These requirements are related to materials, design, manufacturing processes and instructions.

Harmonised Standards

• Technical specifications facilitating compliance

• Use provides a presumption of conformity

• Developed by recognised European standardisation organisations

• Referenced in the Official Journal of the EU

• Directive 2014/68/EU for Pressure Equipment – Summary list

Information and Marking Obligations

• Identification and manufacturer marking

• User manual and safety information

Series Production

The requirement for ongoing conformity is implemented in practice by ensuring that manufacturers identify and keep under control those product and process characteristics whose deviation could jeopardize compliance with the legal requirements.

This requires a systematic management of safety- and compliance-critical characteristics, defining how these characteristics are identified, monitored, controlled, and protected against unintended change.

CE Marking

• Mandatory before placing the product on the EU market

• Must be visible, legible, and permanent

• Notified Body number required if involved

Conclusion

With SAL, the mapping as a roadmap, and consideration of interfaces to related legislation, it becomes clear how PED 2014/68/EU is systematically applied. The final workflow logically follows from scope through requirements, standards, and assessment procedures to CE marking – providing a clear orientation for manufacturers, assessors, and all stakeholders seeking regulatory clarity.