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How to ensure your product complies with the 2014/68/EU Pressure Equipment Directive

23 July 2018

In 2016, the original Pressure Equipment Directive 97/23/EC was replaced by the 2014/68/EU Directive on Pressure Equipment. Here, technical consultant Ferry Vermuelen explains what you need to do as a manufacturer, importer or distributor of pressure equipment to comply with the new directive.

Directive purpose

The purpose of the Pressure Equipment Directive is to ensure the free flow of stationary pressure equipment within the European Union and to ensure that all pressure equipment is safe to operate.

According to the Community Regime of the Directive, when pressure equipment and assemblies are larger than one litre in volume and have a maximum pressure more than 0.5 bar gauge, they must adhere to these requirements:
* They must be safe
* They must meet essential safety requirements covering design, manufacture and testing
* They must satisfy suitable conformity assessment procedures
* They must carry CE marking

When pressure equipment and assemblies fall below a specified pressure and volume threshold:
* They must be safe
* They must be in accordance with sound engineering practices of a member state
* They must bear specified markings (not necessarily the CE marking).

Which products are included/excluded?

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.
Pressure equipment is defined as vessels, piping, safety accessories and pressure accessories, including, where applicable, elements attached to pressurised parts, such as flanges, nozzles, couplings, supports and lifting lugs.

Assemblies are defined as several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.

The type of products covered under the pressure equipment Directive include, but are not limited to, the following:
* Plant vessels
* Pressurised storage containers
* Industrial pipework
* Heat Exchangers
* Shell and water tube boilers
* Boilers
* Steam generators
* Safety devices and pressure accessories

The Pressure Equipment Directive is only applicable to components and sub-assemblies. It is not applicable to pressure equipment assembled on-site while under the supervision and responsibility of the user, as in industrial installations.

Other exclusions include, but are not limited to, equipment designed for nuclear use and equipment covered by other directives, such as the Machinery Directive 2006/42/EC Directive for simple pressure vessels 2014/29/EU.

What if I do not comply with the directive?

Each EU member state is required to lay down rules on penalties for manufacturers, importers and distributors not complying with the Pressure Equipment Directive. As an example, penalties in Germany and the UK are as follows:
* Germany - violation of the "Produktsicherheitsgesetz" (product safety legislation) can result in fines of €3,000 - €30,000 (§ 19) and imprisonment of up to 1 year (§ 20).
* In the UK, directive violations are covered under Section 33 of the HSWA and can result in an unlimited fine and up to two years imprisonment.

For penalties relevant to other specific EU member states, please consult that state's local legislation on product safety.

How do I ensure my product complies with the directive?

Pressure equipment that falls within the scope of the directive requires CE marking before it can be sold in the EEA (EU, Iceland, Lichtenstein and Norway). CE marking proves that your product has been assessed and meets EU safety, health and environmental protection requirements. It is valid for products manufactured both inside and outside the EEA, that are then marketed inside the EEA.

CE marking is valid only for products for which EU specifications have been introduced.
To affix the CE marking to your product, you must put together a technical dossier proving that your product fulfils all the EU-wide requirements. As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. Once your product bears the CE marking, you might have to provide your distributors and/or importers with all the supporting documentation.

To obtain CE marking, manufacturers need to follow these six steps:

1.  What requirements must my product comply with?
Besides the Pressure Equipment Directive, other requirements may apply to your product or assembly. The EU-wide requirements are laid down in directives that cover different products or product sectors, for example Electrical equipment, Machinery or Medical devices.
Each directive lays down the essential requirements that products have to fulfil.

2.  What requirements are relevant to my product?
Once you have identified the applicable directives, you should identify the requirements from each directive that are relevant to your product. It is your responsibility to make sure your product meets all the requirements. A way to ensure that your products meets the requirements, is by using harmonised European standards. If harmonised standards exist for your product and you follow them in the production process, your product will be presumed to be in conformity with the requirements laid down in the relevant EU directives.

The use of standards is voluntary - you are not obliged to use them. You can also opt for other technical solutions to fulfil the essential requirements set out in the relevant EU directive. The available harmonised standards can be found on the site of the European Commission.

3.  How can I prove conformity of my product?
Before a manufacturer can start with the required procedure to assess their product, it is important that they determine whether said product requires self-assessment or whether a Notified Body needs to be involved.

Pressure equipment as defined by the Directive is classified according to different categories. These range from I to IV in accordance with levels of hazard arranged in ascending order, stipulated in Annex II of the Directive.

Higher categories with greater danger have more rigorous conformity assessment modules.
As an example, equipment in Category I is subject to the manufacturer’s own production control, whereas those in Category II, III and IV require involvement of Notified Bodies.

4.  How do I conduct the conformity assessment?
Based on the classification of your pressure equipment, one of the 12 conformity assessment procedures as described in Annex III of the directive needs to be followed, varying from internal production control to type or quality based conformity assurance.

5.  How do I compile the technical file?
Directive 2014/68/EU requires technical documentation to be established by the manufacturer. The technical document is instrumental in the assessment of the conformity of the said appliance with the Directive’s requirements.

Depending on the conformity assessment procedure, the technical document might need to contain the following elements:
* description of the pressure equipment
* conceptual design, manufacturing drawings, diagrams of components, sub-assemblies, circuits, etc.,
* descriptions, explanations which are necessary to understand the drawings and diagrams as well as the operation of the pressure equipment
* list of the harmonised standards
* results of design calculations and examinations
* test reports
* appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the personnel

Besides this, pressure equipment and assemblies need to be accompanied by adequate instructions for use.

6.  How do I draw up the declaration of conformity?
The declaration of conformity shall contain the following information:
* Name and full business address of the manufacturer or the representative authorized to issue the Declaration.
* An identification number of some sort. This number could easily refer to the serial number, product or batch number, model or type.
* A Declaration statement, stating that the Declaration is issued under the sole responsibility of the manufacturer
* Object of the declaration, description of the pressure equipment or assembly, conformity assessment procedure followed, in the case of assemblies, description of the pressure equipment constituting the assembly, and the conformity assessment procedures followed.
* A Declaration statement, stating that the object of the declaration described above is in conformity with the relevant Union harmonisation legislation.
* References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared.
* The name, address and identification number of the Notified Body which carried out the conformity assessment procedure.
* Identity and signature of an authorized person.
* The date the Declaration was issued.

Depending on the applicable directives, it might be required to draw up one single declaration stating compliance with all directives.

After all necessary steps have been taken to complete conformity, the CE mark should be affixed to the product. This marking should be placed on the product in a visible and legible manner and should consist of the initials “CE”.

What should you do as an importer or distributor?

While manufacturers are responsible for ensuring product compliance and affixing the CE marking, importers must make sure that the products they place on the market comply with the applicable requirements and do not present a risk to the European public. The importer has to verify that the manufacturer outside the EU has taken the necessary steps and that the documentation is available upon request.

Distributors must have a basic knowledge of the legal requirements – including which products must bear the CE marking and the accompanying documentation – and should be able to identify products that are clearly not in compliance. They must also be able to demonstrate to national authorities that they have acted with due care and have affirmation from the manufacturer or the importer that the necessary measures have been taken. Furthermore, a distributor must be able to assist national authorities in their efforts to receive the required documentation.

About the author

Ferry Vermeulen is a technical communication expert and director at INSTRKTIV in The Netherlands, which helps brands create compliant and user-friendly instructions.

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