A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.
The aim of the Pressure Equipment Directive is to ensure free circulation of pressure equipment in the EU Market while ensuring a high level of safety towards the end user.
Pressure Equipment Directive applies to vessels, piping, safety accessories and pressure accessories with a pressure higher than 0,5 bar.
EU Legislation on Pressure Equipment
Until the publication of the Pressure Equipment Directive 2014/68/EU on May 15th, 2014 and the subsequent 2-year transition period, the Pressure Equipment Directive 97/23/EC was the reigning legal framework for pressure equipment products. On the 20th of July 2016, the Pressure Equipment Directive 2014/68/EU became fully applicable in the EU as the only legal framework for pressure equipment products.
Any product made available on the EU market (either via e-commerce or in physical stores) must comply with the essential requirements set out by Directive 2014/68/EU.
Non-EU manufacturers wishing to place their products on the EU market should appoint a professional Authorized Representative. (A manufacturer is defined as 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.)
Pressure equipment manufacturers may choose one the conformity assessment procedures laid down in Article 14 according to the applicable PED category.
In some cases, Notified Body intervention may be required.
The Pressure Equipment Directive (PED) 2014/68/EU of the European Parliament and of the Council on the market of pressure equipment replaces the former Pressure Equipment Directive 97/23/EC as from 19th July 2016.
The Pressure Equipment Directive (PED) 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 purpose of the PED is to ensure common standards of safety in all pressure equipment sold within the European Economic Area. Manufacturers are therefore able to meet the requirements for approval in any member state of the EU, and do not have to repeat the process when selling goods in any other state.
- Chapter I: General Provisions (Art. 1-5)
- Chapter II: Obligations of Economic Operators (Art. 6-11)
- Chapter III: Conformity and classification of PED and assemblies (Art.12- 19)
- Chapter V: Notification of Conformity Assessment bodies (Art.20- 43)
- Chapter VI: Committee Procedure and delegated acts (Art.44- 46)
- Chapter VII: Transitional and Final Provisions (Art.47- 52)
- Annex I: Essential Safety Requirements
- Annex II: Conformity Assessment Tables
- Annex III: Conformity Assessment Procedures
- Annex IV: EU Declaration of Conformity
The Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar. Vessels, piping, safety accessories and pressure accessories are all included. Typical examples of pressure equipment covered include:
- Shell and water tube boilers,
- Heat exchangers,
- Pressure vessels,
- Process pipework,
- Electric heaters,
- Valves – isolation,
- Valves – control,
- Relief valves,
- Safety valves,
- Bursting discs,
- Buckling rods,
- Controlled safety pressure relief systems,
- Pressure switches,
- Temperature switches,
- Fluid level switches.
The Directive (art.13) classifies a few categories for pressure equipment, based on:
- Hazard level, which is determined based on stored energy (pressure-volume product)
- Nature of the contained fluid.
The Directive does not apply to:
- Assembly of pressure equipment on site and under the responsibility of the user, as in the case of industrial installations;
- Equipment for military use, for use in transport;
- Equipment which presents a relatively low hazard from pressurization and which is within the scope of another CE mark directive (e.g. the Machinery Directive, Atex Directive, Low Voltage Directive, Medical Lift, )
- Vessels used for the transport of fluids while under pressure (i.e. containers used for the transport of fluids by road, rail, sea and air). These are subject to another directive, the Trans-portable Pressure Equipment Directive (TPED);
- Simple pressure vessels, which are the subject of a separate directive;
- Aerosol dispenser;
- Several classes of equipment as set out in the article 1.2 of the PED 2014/68.
Assessment and conformity procedure are different for each category, in which the equipment is classified (Art.14):
PED Category – Conformity Assessment Route (Annex III)
- Module A: internal production control
- Module A2: Internal production control plus supervised checks at random intervals
- Module B: EU type examination certification
- Module C2 : Conformity to type based one internal production control plus supervised pressure equipment checks at random intervals
- Module D: Conformity to type based on quality assurance of production processes
- Module D1: Quality assurance of the production process
- Module E: Conformity to the type based on pressure equipment quality assurance
- Module E1: Quality assurance of final pressure equipment inspection and testing
- Module F: Conformity to type based on pressure equipment verification
- Module Q: Conformity based on unit verification
- Module H: Conformity based on full quality assurance
- Module A
- Module A2
- Module D1
- Module E1
- Module B+D
- Module B+F
- Module B+E
- Module B+C2
- Module H
- Module B+D
- Module B+F
- Module G
- Module H1
Essential Safety Requirements
The Annex I of the Directive defines certain safety requirements about the design and performance of pressure equipment, such as:
- Equipment must be designed for adequate strength taking into account internal/external pres-sure, ambient and operational temperatures, static pressure and mass of contents in operating and test conditions, traffic, wind, earthquake loading, corrosion and erosion, fatigue, decomposi-tion of unstable fluids;
- It must be ensured safe handling and operation of examination;
- Adequate means shall be provided for the draining and venting of equipment;
- Equipment must be provided with protection against exceeding the allowable limits of pressure;
- Where necessary, pressure equipment must be designed and fitted with suitable accessories to meet damage-limitation requirements in the event of external fire.
Specific requirements are defined for materials used for the manufacturer of pressure equipment.
Pressure equipment or assemblies, which are in conformity with harmonized standards or parts thereof, which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential safety requirements covered by those standards or parts thereof, referred to in Annex I.
The materials used for the manufacture of pressure equipment or assemblies which are in conformity with European approvals for materials, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the applicable essential safety requirements set out in Annex I.
There is a special category of pressure equipment and assemblies – below or equal to the limits set out in all the other categories – which must be designed and manufactured in accordance with the Sound Engineering Practice (SEP) of a Member State to ensure safe use.
The Essential Safety Requirements of the Directive do not apply to product falls in the SEP category but can be a good guidance in absence of other instructions. A derogation it is also made for the CE marking of SEP, since Article 4 paragraph 3 explicitly prohibits CE marking of SEP pressure equipment.
The manufacturer shall draw up the technical documentation referred to in Annex III of the Directive.
Non-compliant products enter the EU Market everyday – whether manufacturer knowingly does so or due to a lack of control from the EU importer/distributor on the compliance requirements of products.
Each Competent Authorities of Member State focus on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market. In the case that a product is found to be non-complaint, the main consequences include, but are not limited to:
- Being publicly reported to the RAPEX,
- Warehousing Fees,
- Requested Withdrawal,
- Mandated Withdrawal,
- Product Recall (from end-users and/or the market),
- Complete ban on marketing of the product,
- Destruction of the product,
- Revocation of the CE Marking.
The professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling post-market surveillance case play a vital role in the successful recovery of your brand in the EU Market.
It is the responsibility of the manufacturer to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to be compliant as the legislation applicable to their products evolves. Post-marketing surveillance activities include, but are not limited to:
- Staying up-to-date on new requirements or legislative changes,
- Continual updating of the technical file as modifications are made to the product,
- Reporting of any incidents related to the product use,
- Removal of non-compliant batches from EU economics operators and end-user,
- Keeping technical file available for 10 years after the last batch entered the EU market.
Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.