Pressure Equipment Directive
Pressure Equipment Directive 2014/68/EU (PED)
The Pressure Equipment Directive is to ensure the free flow of stationary pressure equipment within the European Union. At the same time, it is to ensure that all pressure equipment passes a high degree of safety.
According to the Directive, when pressure equipment and assemblies fall above a specified pressure and volume threshold 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 the CE marking
The PED applies to pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar, although there are a number of exclusions, which are set out in the directive.
“Pressure equipment” means; pressure vessels, steam boilers, piping, safety accessories and pressure accessories. “Assembly” means several pieces of pressure equipment assembled to form an integrated, functional whole.
In order to know how the Regulations apply to specific items of pressure equipment, the manufacturer will need to know:
• the type of equipment concerned, i.e. vessel, steam generator or piping;
• the state of the intended fluid contents – gas or liquid; and
• the fluid group of the intended contents – Group 1 or Group 2.
Group 1 also comprises substances and mixtures contained in pressure equipment with a maximum allowable temperature TS which exceeds the flashpoint of the fluid.
Group 2 comprises substances and mixtures not referred to under group 1, within the definition of a fluid, including steam.
With this information the manufacturer can identify the relevant chart in Annex II of the Directive and determine the correct classification of the equipment by plotting the maximum allowable pressure and, in the case of vessels, the volume in litres or, for piping, the nominal size (DN). If you need any assistance with these charts feel free to contact us.
The new PED incorporates the term "economic operators" and lays down legal obligations for each one. Now importers and distributors have role and responsibilities in the supply chain too.
An economic operators is:
• A manufacturer: Any natural or legal person who manufactures pressure equipment or an assembly or has such equipment or assembly designed or manufactured, and markets that pressure equipment or assembly under his name or trademark or uses it for his own purposes.
• An authorised representative: Any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks.
• An importer: Any natural or legal person established within the Union who places pressure equipment or assemblies from a third country on the Union market.
• A distributor: Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes pressure equipment or assemblies available on the market.
The obligations of manufacturers of pressure equipment:
1. Before placing pressure equipment on the market or using it for their own purposes, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential safety requirements.
2. The manufacturer then must classify the equipment or assembly into the appropriate category, determine the conformity procedure that applies and carry out the relevant conformity assessment procedure and draw up the relevant technical documentation. Once this has been done, a manufacturer must draw up a declaration of conformity, ensure that declaration accompanies the product and affix the CE marking to the product. Where applicable, they must also ensure that the identification number of the notified body is affixed to the equipment or assembly.
3. Manufacturers must keep the declaration of conformity up to date and keep it and the relevant technical documentation for 10 years.
4. Manufacturers must also label their products with their name, registered trade name or registered trade mark and address; the type batch or serial number (or other identification) in a language that is easily understood by the end user. Where the end user is in the UK, that language is English. This applies to all products (including those to which regulation 8 refers).
5. When placing pressure equipment or an assembly on the market, a manufacturer must ensure that it is accompanied by instructions and safety information in a language which can be easily understood by the end user. This applies to all products (including those to which regulation 8 applies).
6. When appropriate, with regard to the risks to the health and safety of consumers and other users, they must carry out sample testing and they must investigate any complaints that the pressure equipment is not in conformity and keep records of these complaints.
7. They must take action where they have reason to believe that any product is not in conformity with the Regulations.
Whether the manufacturer is established in the EU or not, he may appoint an authorised representative in the Union to act on his behalf in carrying out certain tasks required in the applicable Union harmonisation legislation.
Where the manufacturer appoints an authorised representative, the mandate shall at least allow the authorised representative to perform the following tasks:
1. Keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities and cooperate with them at their request,
2. Upon a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product;
3. Cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.
The Importers obligations
The importer is defined as any natural or legal person who places a product from a third country on the EU market. As a general rule, before placing a product on the market the importer must ensure:
1. that the appropriate conformity assessment procedure has been carried out by the manufacturer. If he has any doubt about the conformity of the product, he must refrain from placing it on the market. If the product has already been placed on the market, he has to take corrective actions. In both cases the manufacturer might need to be contacted to clarify any doubt about the conformity of the product.
2. that the manufacturer has drawn up the technical documentation, affixed the relevant conformity marking (e.g. CE marking), fulfilled his traceability obligations and accompanied, where relevant, the product by the instructions and safety information in a language easily understood by consumers and other end-users, as determined by the Member State concerned.
These obligations are meant to make sure that the importers are aware of their responsibility to place only compliant products on the market.
The importer also has to:
1. Indicate the following three elements: his (1) name, (2) registered trade name or trade mark and (3) the address at which he can be contacted on the product or where not possible because of the size or physical characteristics of the product or because the packaging would need to be opened, on the packaging or/and on the accompanying documentation. By doing so, he must not impede the visibility of any safety information printed on the product or the accompanying documents.
2. Ensure that, while a product is under his responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in the applicable legislation. or for the period specified in the relevant Union harmonisation act.
3. Keep a copy of the EU Declaration of Conformity for 10 years after the product has been placed on the market
4. Ensure that the technical documentation can be made available to the competent national authority upon request. The importer has to cooperate with that authority and upon a reasoned request, has to provide that authority with all the information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority. The idea is that the national authority might accept a language they understand and which is different from the national language(s). The language chosen is subject to negotiation with the authority and could be a third language, if accepted by the authority.
In the case of a reasoned request it is sufficient for the importer to provide the part of the technical documentation related to the claimed non-conformity and appropriate for demonstrating whether the issue has been dealt with by the manufacturer. Therefore, any request for translation of technical documentation should be limited to these parts of the documentation.
5. On request by market surveillance authorities, the importer must identify any economic operator who has supplied him and to whom he has supplied the product. He must be able to present this information for a period of 10 years after he has been supplied with the product and for a period of 10 years after he has supplied the product.
Distributor must act with due care in relation to the applicable requirements. They have to know, for instance, which products must bear the CE marking, what information is to accompany the product (for example the EU Declaration of Conformity), what are the language requirements for labelling, user instructions or other accompanying documents, and what is a clear indication of the product being non-compliant. Distributors have an obligation to demonstrate to the national market surveillance authority that they have acted with due care and ensure that the manufacturer, or his authorised representative, or the person who provided him with the product has taken the measures required by the applicable Union harmonisation legislation as listed in the obligations for distributors.
Before making a product available on the market, the distributor must verify the following formal requirements:
1. Only supply compliant products.
2. that the product bears the required conformity marking(s)(e.g. CE marking);
3. that the product is accompanied by the relevant documents (e.g. EU Declaration of Conformity) and by instructions and safety information in a language which can be easily understood by consumers and other end-users if required by the applicable legislation;
4. that the manufacturer and importer have indicated their (1) name, (2) registered trade name or trademark and (3) the address at which they can be contacted on the product or when not possible because of the size or physical characteristics of the products, on its packaging and/or on the accompanying documentation, and that the product bears a type, batch or serial number or other element allowing the identification of the product.
5. Not place non-conforming product on the market, and inform the relevant national authorities if non-conforming product in their possession presents a risk.
6. Ensure that storage and transport conditions do not jeopardise the conformity of the equipment.
7. Take any corrective action required to ensure that non-conforming product which they have sold is made to conform, or where appropriate to recall or withdraw it from the market. Note: This requires the distributor to have some form of traceability of the product
8. Immediately inform the relevant national authorities if the non-conforming product presents a risk.
9. Provide information or documentation in paper or electronic form if requested.
10. Co-operate with authorities on any action to eliminate the risks posed by CE marked equipment which they have placed on the market.
Module A Category I
Internal production control can only be applied when the pressure equipment when categorised falls with in Sound Engineering Practices (SEP) or Category I
Internal production control is the conformity assessment procedure whereby the manufacturer conducts a hazard risk assessment and completes the technical documentation laid down in points 2, 3 and 4, below and supplies with the product instructions for use, and declaration of conformity which declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive and any other applicable directives.
Module A2, D1 & E1 Category II
These requirements require some sort of notified body involvement, although the manufacture is responsible for the hazard risk assessment and technical documents, as detailed in section 2 and 4 below, plus supplying the customer with the instruction and DoC with a copy of the EU type examination certificate or unit verification certificate
Module A2 requires an Internal production control with monitoring of the final assessment by a notified body
Module D1 requires QA system for production to be assessed by notified body
Module E1 requires QA system and final inspection assessment by notified body
Module H Category III
Module H requires the notified body to evaluate the full quality system, production, design, final inspection and test
Module H1 Category IV
Module H1 requires the notified body to evaluate the full quality system, conduct a design examination and surveillance assessment
All the other categories the Notified Bodies produce an EU type examination for production or design dependent on quality assessments except module G which is a one off examination of the design and produces a Unit verification certificate
2. Technical documentation
The manufacturer shall establish the technical documentation.
The technical documentation shall make it possible to assess the conformity of the pressure equipment to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment.
The technical documentation shall, wherever applicable, contain 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 of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
• results of design calculations made, examinations carried out, etc.,
• test reports.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured pressure equipment with the technical documentation referred to in point 2 and with the requirements of this Directive.
4. CE marking and EU declaration of conformity
• The manufacturer shall affix the CE marking to each individual pressure equipment that satisfies the applicable requirements of this Directive.
• The manufacturer shall draw up a written EU declaration of conformity for the pressure equipment model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up.
• A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
PED Important references:
1. See Article 1(1) for scope and Article 1(2) for out of scope
2. See Article 2(1) for the definition of pressure equipment.
3. See Article 2(4) for the definition of safety accessories.
4. See Article 2(6) for the definition of assemblies. Also note that the last sentence of Recital 7 states that the Directive should not apply to the assembly of pressure equipment on the site and under the responsibility of a user who is not the manufacturer, as in the case of industrial installations.
5. See Article 2(18) for the definition of a manufacturer.
6. Article 14 sets out which conformity assessment procedures are available for each category. A manufacturer may also choose to apply one of the procedures which apply to a higher category.
7. See essential safety requirement in Annex I.
8. The conformity assessment procedures are set out in Annex III, and these include details of the extent of a notified body’s involvement for each module.
9. MODULE A “Internal Production Control” is the only conformity assessment procedure that does not require some sort of notified body involvement as the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive.
HOW WE CAN HELP:
Our customers contact us because they need help and advice on how to apply the UKCA or CE Mark to their products.
The CE Marking Authority has a positive attitude and approaches regulatory compliance by looking at the opportunities rather than seeing them as an inconvenience and meddling with your practices. We specialize in staying ahead of the game by using our technical knowledge (skills) conducting the necessary assessments to help our clients demonstrate their technical files meet the requirements of the regulations
Our expert team is here to help you meet the UKCA and CE Marking the requirements
• Free initial consultation to assess your requirements and plan the CE marking of your product.
• Identify the statutory instruments, the essential safety requirements, and harmonized standards, which apply to the product.
• Perform design risk assessments and clause by clause assessments against the designated standards
• Conduct a product compliance report to the applicable requirements outlining areas of non-compliance and advice on how to close out any gaps found.
• Assist in the compilation of the technical construction file, which contains the information required by the EU safety regulations.
• Provide a draft EU Declaration of Conformity and help you complete it.
• Offer follow up advice on changes in requirements for the life cycle of the product
• Act as your Authorised Representative in the UK or EU via or European office if required.
The many benefits of compliance range from brand and reputation, revenue enhancement, asset protection, higher profitability, and lower costs, improved workforce performance, the provision of better data for better-made business decisions, and allows for a total harmonization of your systems