Overview of the Pressure Equipment Directive 2014/68/EU
Are you a manufacturer and is your pressure equipment in conformity with the essential requirements of this directive? Then you are permitted to affix a CE marking to your pressure equipment. In this article you will learn more about obtaining a CE marking and which steps to follow. You will also learn more about the responsibilities of the importers and the distributors of pressure equipment.
Which products are covered by the Pressure Equipment Directive 2014/68/EU?
In the scope of the Directive, pressure equipment covers pressure vessels, installation piping, safety accessories, other pressure accessories and the elements attached to pressurised parts, such as flanges, nozzles, couplings, supports and lifting lugs. These terms are explained in greater detail in article 2.
Article 1, paragraph 2 of the Pressure Equipment Directive 2014/68/EU includes a complete listing of products that are not covered by the Pressure Equipement Directive.
When is CE marking a pressure equipment mandatory?
CE marking is mandatory when pressure equipment is traded, put into operation, placed or put into use on the market within the European Economic Area.
CE marking is not mandatory in the case of trade fairs, exhibitions and demonstrations. It is required, though, to provide a sign, indicating that the equipment does not comply (yet) with the Pressure Equipment Directive and a CE marking will become mandatory the moment the equipment will be placed on the market. During demonstrations it will also be required to take the necessary measures to ensure the safety of persons.
Who must comply with the Pressure Equipment Directive?
Are you a manufacturer of pressure equipment? In that case you are responsible for the CE marking procedure. Are you an importer or a distributor of pressure equipment? In that case you must verify whether the (foreign) manufacturer has carried out the CE marking procedure in accordance with the relevant requirements of this Directive.
The Pressure Equipment Directive 2014/68/EU describes the role of each economic operator (manufacturer, importer or distributor) in the CE-marking process.
Please note: are you an importer or distributor who places pressure equipment on the market under his own registered trade mark? Of have you modified a pressure equipment that was already placed on the market in such a way that its compliance with the requirements of this Directive may have been influenced? In that case you will be considered a manufacturer in the scope 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.
Contact our experts
The experts of Certification Company are capable of guiding you or performing the entire CE-marking procedure on your behalf. We can also assist you with the selection and guidance of the Notified Body. Please feel free to contact us by phone +31 (0)36 202 40 12 or by e-mail.