Directive 2014/68/EU (PED):
the regulatory framework for pressure equipment in the EU
A technical guide to the scope of application, risk category classification and conformity assessment modules established by the Pressure Equipment Directive.
Directive 2014/68/EU of the European Parliament and of the Council, of 15 May 2014, on the harmonisation of the laws of Member States relating to the making available on the market of pressure equipment — commonly known as the Pressure Equipment Directive or PED — is the European regulatory instrument governing the design, manufacture and conformity assessment of pressure equipment intended for the internal market.
For any manufacturer or industrial user of pressure equipment — heat exchangers, vessels, boilers, process pipework and fittings — understanding the scope and logic of this Directive is a prerequisite for operating safely and in legal compliance within the European Economic Area.
1. Background and regulatory context
Directive 2014/68/EU repealed and recast the previous Directive 97/23/EC, which ceased to apply on 19 July 2016. The recast did not substantially modify the essential safety requirements or the conformity assessment tables, but aligned the legislation with the New Legislative Framework (NLF) of the European Union — in particular Regulation (EU) No 765/2008 and Decision 768/2008 — introducing explicit obligations for all economic operators in the supply chain: manufacturers, authorised representatives, importers and distributors.
Directive 2014/68/EU of the European Parliament and of the Council, of 15 May 2014 (OJ L 189, 27 June 2014, pp. 164–259). Full entry into force: 19 July 2016.
2. Scope of application
The Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure (PS) greater than 0.5 bar gauge.
| Element | Description under the Directive |
|---|---|
| Vessels | Housings designed and built to contain fluids under pressure, including shell-and-tube heat exchangers. |
| Piping | Piping components intended for the transport of fluids, including pipes, piping systems, fittings, expansion joints and hoses. |
| Safety accessories | Devices protecting against the exceedance of allowable limits: safety valves, pressure relief devices, automatic control systems, etc. |
| Pressure accessories | Devices with an operational function subject to pressure: non-return valves, regulators, steam traps, filters, etc. |
| Assemblies | Several items of pressure equipment assembled by a manufacturer to constitute an integrated functional installation. |
Notable exclusions
The Directive expressly excludes from its scope, among others: simple pressure vessels covered by Directive 2014/29/EU; aerosol generators; equipment intended for vehicle operation; certain water distribution networks; nuclear equipment; and well-control equipment for the extractive industry.
3. Fluid classification and its significance
One of the Directive's central pillars is the classification of the fluids contained in the equipment, which determines — together with the pressure and volume or nominal diameter parameters — the applicable risk category. Directive 2014/68/EU updated the classification relative to the previous legislation, aligning it with Regulation (EC) No 1272/2008 (CLP) on classification, labelling and packaging of substances and mixtures.
| Group | Fluids included (simplified criterion) |
|---|---|
| Group 1 | Fluids considered hazardous: explosive, extremely or highly flammable, toxic, very toxic, oxidising and corrosive under the CLP Regulation, as well as any fluid at a maximum allowable temperature (TS) above its flash point. |
| Group 2 | All fluids not included in Group 1, commonly referred to as "non-hazardous fluids". |
The Directive establishes that thermal oils are classified as Group 1 when the maximum allowable temperature of the equipment exceeds the flash point of the oil in question, regardless of its CLP classification. This specific criterion, set out in Commission Guideline B-41, has direct implications for the resulting category of the equipment.
4. Risk categories
The Directive establishes four risk categories (I to IV) for pressure equipment. Category assignment is determined using the tables in Annex II, which cross-reference fluid parameters with equipment parameters (PS, volume V or nominal diameter DN).
Low-pressure or small-volume equipment. The manufacturer may self-certify via Module A (internal production control).
Requires involvement of a Notified Body in the production phase. Available modules: A2, D1, E1.
Notified Body involvement in design and/or production. Modules: B+D, B+F, B+E, B1+D, G, H.
Maximum requirements. Notified Body required at all stages. Permitted modules: B+D, B+F, G, H1.
5. Conformity assessment modules
| Module | Name | NB required | Summary |
|---|---|---|---|
| A | Internal production control | No | Manufacturer's self-declaration. Applicable to Category I only. |
| A2 | Internal production control with supervised checks | Yes | The NB performs random inspections of the finished product. |
| B | EU-type examination (production type) | Yes | The NB examines a representative specimen. Must be combined with a production-phase module (D, E or F). |
| B1 | EU-type examination (design type) | Yes | The NB examines the design technical documentation without a physical prototype. |
| D / D1 | Production quality assurance | Yes | The NB approves and supervises the manufacturer's quality system in the production phase. |
| E / E1 | Product quality assurance | Yes | The NB approves and supervises the quality system for final inspections and testing. |
| F | Product verification | Yes | The NB verifies each produced unit by examination and testing. |
| G | Unit verification | Yes | Individual assessment of each item by the NB, both in design and production. Common for one-off equipment. |
| H / H1 | Full quality assurance | Yes | The NB approves and supervises the complete quality management system. H1 adds design examination and special surveillance. |
6. Economic operator obligations
Manufacturer
- Ensure the equipment has been designed and manufactured in accordance with the essential safety requirements of Annex I.
- Carry out or commission the appropriate conformity assessment procedure for the equipment's category.
- Draw up the technical documentation and the EU Declaration of Conformity, and retain both documents for ten years from the date the equipment is placed on the market.
- Affix the CE marking and the Notified Body identification number (where applicable) to the equipment.
- Ensure that series production continues to meet the requirements, taking into account design changes or updates to harmonised standards.
7. CE marking and the EU Declaration of Conformity
The CE marking is the visible indication that the manufacturer declares the equipment meets all applicable requirements of the Directive. It is not a quality mark or third-party certification in itself; it is a statement of the manufacturer's responsibility.
The Directive provides, in Article 4.3, for low-risk equipment (small vessels and piping not exceeding certain PS × V or PS × DN thresholds) that need only be designed and manufactured in accordance with sound engineering practice, without being subject to the conformity assessment procedure or bearing CE marking.
8. General certification process: schematic overview
Determine whether the equipment falls within the scope of the Directive, considering PS, fluid type and possible exclusions.
Assign the fluid to Group 1 or Group 2 according to the CLP Regulation and the Directive's specific criteria (including the temperature/flash point criterion).
Apply the Annex II tables, cross-referencing fluid group, physical state, PS and volume or DN, to obtain the Category (I to IV) or application of Article 4.3.
Choose the module or combination of admissible modules for the determined category, considering the manufacturer's quality management system and production volume.
Select a Notified Body (NoBo) authorised for the applicable module. All Notified Bodies are listed in the European Commission's NANDO database.
The manufacturer assembles and retains the technical documentation and issues the EU Declaration of Conformity.
Once the assessment process is complete, the CE marking (and the NB identification number, where applicable) is affixed to the equipment.
9. Relationship with national pressure equipment regulations
Directive 2014/68/EU governs the placing on the market of pressure equipment. Installation, use, periodic inspection and maintenance of equipment in service fall outside its scope and are governed by each Member State's own legislation. Each EU country has its own complementary national regulations that apply once the equipment is installed and commissioned.
10. Final thoughts
Directive 2014/68/EU represents a mature technical and legal framework that, correctly applied, provides strong guarantees regarding the safety of pressure equipment operating on the European market. Its structure — essential safety requirements, risk-based classification, assessment modules, harmonised standards — gives manufacturers the flexibility to demonstrate conformity through different routes, with the level of third-party involvement proportionate to the equipment's inherent risk.