Directives

If your product(s) fall(s) within the sector of Pressure equipment, Directive 2014/68/EU applies.

• Directive 2014/68/EU on Pressure equipment
• For further information on the Directive 2014/68/EU on Pressure equipment, please visit the Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs webpage dedicated to this sector by following this link: https://ec.europa.eu/growth/sectors/pressure-gas/pressure-equipment_en

Verify requirements

The New Approach Directives for CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

Directive 2014/68/EU on Pressure Equipment specifies the essential requirements the product must meet in order for the manufacturer to affix the CE Marking.

The Directive defines pressure equipment as vessels, piping, safety accessories and pressure accessories, including, where applicable, elements attached to pressurised parts, such as flanges, nozzles, couplings supports, lifting lugs, and applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.

The pressure equipment covered by the Directive is subject to the essential safety requirements listed in Annex I of the Directive.

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

The pressure equipment in the scope of the Directive is classified in different categories (ranging from I to IV), according to ascending level of hazard in accordance with Annex II of the Directive.

The involvement of a Notified Body is obligatory for equipment of category II or higher.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports the product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of product compliance, it will issue a certificate to confirm this. The manufacturer will then draw up the EU Declaration of Conformity ( EU DoC) to declare on his sole responsibility conformity to the relevant Directive. The establishment of the EU DoC is a legal obligation.

The EU Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, any harmonised standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. For further details please consult the Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please refer to NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

According to the category in which the equipment was classified, the manufacturer will be given a choice of ‘modules’. The higher the category and therefore the greater the hazards, the more demanding the conformity assessment modules are. Equipment in Category I will be subject to the manufacturer’s own internal production control.

The modules for products in Categories II, III & IV will require the involvement of Notified Bodies, either in the approval and monitoring of the manufacturers’ quality assurance system or in direct product inspection. A description of different conformity assessment procedure is given in Annex III of the Directive.

Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EU Declaration of Conformity.

Technical documentation

Directive 2014/68/EU on Pressure Equipment requires the manufacturer to establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The documentation must contain, wherever applicable, at least the following elements:

• a general description of the pressure equipment
• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
• descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment
• a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and a description of the solutions adopted to meet the essential safety requirements where harmonised standards have not been applied
• results of design calculations made, examinations carried out etc.
• test reports.

The manufacturer or their authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the marking must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product e.g. if it is too small, it will be given on a label attached to the pressure equipment. The CE marking shall consist of the initials 'CE' taking the following form:

The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

If a Notified Body is involved in the production control phase, its identification number must be also displayed.

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