Overview of the Pressure Equipment Directive 2014/68/EU

Step 1: Product classification

Determine if the equipment falls within the scope of the Pressure Equipment Directive. For this purpose please refer to the articles 1, 2 and 4 of the Pressure Equipment Directive. Furthermore, determine the category of the equipment, based on established criteria. More information concerning the categories are included in the articles 13 and 14 and Annexes II and III of the Directive. If an assembly consisting of various pieces of pressure equipment belongs to more than one category, the highest category will be applicable.

Step 2: Conformity assessment procedure

The conformity assessment procedure of the Pressure Equipment Directive consists of a number of intermediate steps, as described in the articles 6 and 14 of the Directive:

• Carry out product testing in accordance with the European (harmonised) standards. The procedure to be followed depends on the category of the pressure equipment, as mentioned under point 1. The assessment of pressure equipment in category II and higher requires the designation of a Notified Body.
• Develop procedures to ensure the conformity of serial production.
• Attach identification labels on the equipment or its package, containing information, such as type, batch, serial or model number, your registered trade name or registered trade mark, and postal address.
• Draw up instructions for use and safety information in a language that is is easily understood by consumers and users.
• Develop procedures for taking corrective measures, such as sample testing, procedures for handling complaints, as well as procedures for the recalls of equipment.

Step 3: Technical Files

The Technical Documentation will enable you to assess the product’s compliance to this Directive. Please be referred to Annex III of the Pressure Equipment Directive 2014/68/EU. This annex presents you, by category, with a list of the documents that must be included in the Technical Documentation. The Technical Documentation must be kept for 10 years, as of the date that the equipment is placed on the market.

Step 4: CE Declaration of Conformity

DoC is a document confirming that your equipment complies with the Pressure Equipment Directive 2014/68/EU. By signing this declaration you will take upon you the responsibility for the conformity of the equipment. The declaration must comply with the requirements of article 17 and Annex IV of the Directive. The declaration must be signed by you and kept for 10 years, as of the date that the equipment is placed on the market. Upon the request of market surveillance authorities, the declaration must be made available to the authorities.

Step 5: CE marking

After successfully completing all of the previous steps, the CE marking may be affixed to the equipment. The details for affixing the CE marking are included in the articles 18 and 19 and Annex III of the Pressure Equipment Directive 2014/68/EU.

Are you an importer of pressure equipment? In that case you are only allowed to place your product on the market within the European Economic Area, when the product complies with the relevant requirements of the directive. Article 8 of the Pressure Equipment Directive will then apply to you. In short, you will carry out the following tasks:

• Verify whether the manufacturer has carried out the correct conformity assessment procedure, has compiled the Technical Files, has affixed the CE marking to the equipment, and whether the equipment is accompanied by the required documents.
• Indicate your registered trade name or registered trade mark and your postal address on the equipment or its package.
• See to it that the instructions for use and information will be drawn up in a language that is easily understood by consumers.
• Ensure safe transport and storage of the equipment during the periode that it is under your responsibility.
• Establish procedures for taking corrective measures.
• Ensure that you have a copy of the CE Declaration of Conformity.

Are you a distributor of pressure equipment? In that case article 9 of the Pressure Equipment Directive will apply to you. In short, you will carry out the following tasks:

• Act with care.
• Verify whether the equipment bears a CE marking and is accompanied by the required documents and instructions in a language that is easily understood by consumers, before placing the equipment on the market.
• Ensure safe transport and storage of the equipment during the period that it is under your responsibility.
• Establish procedures for taking corrective measures.