The Certificate of Conformity Europe (CE Mark) is a mark to indicate that the product to which it is affixed is in conformance with EU Product Safety Directives. These EU Directives apply to all products that are to be put into service for the first time inside the European Economic Area.
The CE consultants at Universal Certifiers know exactly what is necessary and what is not required in order to attain the Certificate of Conformity for Europe for your industrial products. Many issues arise before you can use the CE Mark, such as which EU Directives and standards are applicable, who is responsible for what, is a Notified Body required, how safe are the industrial products, what manuals are needed, how can we safeguard industrial machines, etc.
Certifier’s bureau will guide your organisation on the following questions:
What is CE MARK?, How to get CE MARK certificate?, How to implement CE MARK standards?, How much does it cost to get CE MARK certificate?, who are CE MARK service providers?, what is the validity of CE MARK certificate?, what are the documents required to get CE MARK certificate?, How to verify the CE MARK certificate online?, How much days it takes to get CE MARK certified?, Can anyone get ISO certificate?, Who issues CE MARK certificate?, Does CE MARK certificate mandatory for government tenders?
Existing in its present form since 1985, the CE marking indicates that the manufacturer or importer claims compliance with the relevant EU legislation applicable to a product, regardless of the place of manufacture. By affixing the CE marking on a product, a manufacturer effectively declares, at its sole responsibility, conformity with all of the legal requirements to achieve CE marking which allows free movement and sale of the product throughout the European Economic Area. (EEA)
For example, most electrical products must comply with the Low Voltage Directive and the EMC Directive; toys must comply with the Toy Safety Directive. The marking does not indicate EEA manufacture or that the EU or another authority has approved a product as safe or conformant.The EU requirements may include safety, health, and environmental protection, and, if stipulated in any EU product legislation, assessment by a Notified Body or manufacture according to a certified production quality system. The CE marking also indicates that the product complies with directives in relation to “Electro Magnetic Compatibility” – meaning the device will work as intended, without interfering with the use or function of any other device.
Not all products need CE marking to be traded in the EEA; only product categories subject to relevant directives or regulations are required (and allowed) to bear CE marking. Most CE-marked products can be placed on the market subject only to an internal production control by the manufacturer (Module A; see Self-certification, below), with no independent check of the conformity of the product with EU legislation; ANEC has cautioned that, amongst other things, CE marking cannot be considered a “safety mark” for consumers.
CE marking involves self-certification only in case of minimal risks products. In most cases a notified body must be involved. In these cases the CE mark is followed by the registration number of the Notified body involved in conformity assessment.
CE marking is mandatory for certain product groups within the European Economic Area (EEA; the 28 member states of the EU plus EFTA countries Iceland, Norway and Liechtenstein) plus Switzerland and Turkey. The manufacturer of products made within the EEA and the importer of goods made in other countries must ensure that CE-marked goods conform to standards.
As of 2013, CE marking was not required by countries of the Central European Free Trade Agreement (CEFTA), but members Albania, Republic of Macedonia, Serbia, and Montenegro had applied for membership of the European Union, and were adopting many of its standards within their legislation (as did most Central European former member countries of CEFTA that joined the EU, before joining).
Responsibility for CE marking lies with whoever puts the product on the market in the EU, i.e. an EU-based manufacturer, the importer or distributor of a product made outside the EU, or an EU-based office of a non-EU manufacturer.
The manufacturer of a product affixes the CE marking to it but has to take certain obligatory steps before the product can bear CE marking. The manufacturer must carry out a conformity assessment, set up a technical file and sign a Declaration stipulated by the leading legislation for the product. The documentation has to be made available to authorities on request.
Importers of products have to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request. Importers should also make sure that contact with the manufacturer can always be established.
Distributors must be able to demonstrate to national authorities that they have acted with due care and they must have affirmation from the manufacturer or importer that the necessary measures have been taken.
If importers or distributors market the products under their own name, they take over the manufacturer’s responsibilities. In this case they must have sufficient information on the design and production of the product, as they will be assuming the legal responsibility when they affix the CE marking.
There are certain rules underlying the procedure to affix the marking:
Since achieving compliance can be very complex, CE-marking conformity assessment, provided by a notified body, is of great importance throughout the entire CE-marking process, from design verification, and set up of the technical file to the EU declaration of conformity.
A guide to the implementation of directives based on the New Approach and the Global Approach (the “Blue Guide”) was first published by the European Union in 2000. Updated versions were published on 28 February 2014 and 26 July 2016.
Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who needs to ensure that the product meets all the CE marking requirements. In some cases, if a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and affixing the CE marking to their own product. Self-certification exists only for products which have a minimal risk for their use, and this is clearly foreseen in the relevant Directive according to the product “category”. In order to certify, the Manufacturer must do several things:
The level of risk is defined by the “category” of each equipment. The higher category the higher the risk. After defining the category then the manufacturer, in order to obtain certification, shall apply the relevant procedures for the certain category of the product or choose the relevant procedures for a higher category product. The manufacturer after insuring that the relevant modules for the product category have been applied him will affix the CE mark and draw up a Declaration of Conformity. The Declaration of Conformity contains description of the product, The Directive (xxxx)or the Directives applied, the product category for each Directive, The Module chosen and the name and registration Number of the Notified Body involved in certification procedures (Models).
Notified Bodies involved in certification procedures are organizations that has been nominated by a Member State (according to an accreditation procedure) and have been notified by the European Commission. These notified bodies act as Independent Inspection organizations and carry out the procedures as listed in the relevant Modules applied as stated by the relevant directives. A manufacturer can choose any notified body (notified for the certain directive and relevant Modules) in any Member State of the European Union.
In reality the self-certification process consists of the following stages:
Stage 1: Identify the applicable Directive(s)
The first step is to identify whether the product needs to bear CE marking or not. Not all products are required to bear CE marking, only the products that fall within the scope of at least one of the sectorial directives requiring CE marking. There are more than 20 sectorial product directives requiring CE marking covering, but not limited to, products such as electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices and construction products.
Identifying which directive(s) may be applicable, as there may be more than one, involves a simple exercise of reading the scope of each directive to establish which apply to the product (Such as the “Low Voltage Directive,” 2014/35/EU). If the product does not fall within the scope of any of the sectorial directives, then the product does not need to bear CE marking (and, indeed, must not bear CE marking).
Stage 2: Identify the applicable requirements of the Directive(s)
Each Directive has slightly different methods of demonstrating conformity depending on the classification of the product and its intended use. Every Directive has a number of ‘essential requirements’ that the product has to meet before being placed on the market.
The best way to demonstrate that these essential requirements have been met is by meeting the requirements of an applicable ‘harmonised standard,’ which offer a presumption of conformity to the essential requirements, although the use of standards usually remains voluntary. Harmonised standards can be identified by searching the ‘Official Journal’ on the European Commission’s website, or by visiting the New Approach website established by the European Commission and EFTA with the European Standardisation Organisations.
Stage 3: Identify an appropriate route to conformity
The process is not always a self-declaration process, there are various ‘attestation routes’ to conformity depending on the Directive and classification of the product. Many products (such as invasive medical devices, or fire alarm and extinguisher systems, Pressure Equipment, Lifts etc.) in most cases, have a mandatory requirement for the involvement of an authorised third party e.g. a “notified body”.
There are various attestation routes which include:
Stage 4: Assessment of the product’s conformity
When all of the requirements have been established, the conformity of the product to the essential requirements of the Directive(s) needs to be assessed. This usually involves assessment and/or testing, and may include an evaluation of the conformity of the product to the harmonised standard(s) identified in step 2.
Stage 5: Compile the technical documentation
Technical documentation, usually referred to as the technical file, relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development and manufacture of the product.
Technical documentation will usually include:
Stage 6: Make a declaration and affix the CE marking
When the manufacturer, importer or authorised representative is satisfied that their product conforms to the applicable Directives, an EU declaration of conformity must be completed or, for partly completed machinery under the Machinery Directive, an ECU declaration of incorporation.
The requirements for the declaration vary slightly, but will at least include:
The EU declaration of conformity must include: manufacturer’s details (name and address, etc.); essential characteristics the product complies; any European standards and performance data; if relevant the identification number of the notified body; and a legally binding signature on behalf of the organization.
The directives requiring CE marking affect the following product groups:
There are numerous ‘Agreements on Mutual Recognition of Conformity Assessment’ between the European Union and other countries such as the USA, Japan, Canada, Australia, New Zealand and Israel.Consequently, CE marking is now found on many products from these countries. Japan has its own marking known as the Technical Conformity Mark.
Switzerland and Turkey (which are not members of the EEA) also require products to bear CE marking as an affirmation of conformity.
When the manufacturer of a machine puts the CE marking, it engages itself and guarantees, that it makes all the tests, assessments and evaluation on the product to conform to all the requirements of all the directives that apply to its product.
On motor vehicles and related parts, the UNECE “e mark” or “E mark”, rather than the CE logo, has to be used. Contrary to the CE logo, the UNECE marks are not self-certified.
Not to be confused with estimated sign.
They are not to be confused with the estimated sign on food labels.
The European Commission is aware that CE marking, like other certifications marks, is misused. CE marking is sometimes affixed to products that do not fulfill the legal requirements and conditions, or it is affixed to products for which it is not required. In one case it was reported that “Chinese manufacturers were submitting well-engineered electrical products to obtain conformity testing reports, but then removing non-essential components in production to reduce costs”.A test of 27 electrical chargers found that all the eight legitimately branded ones with a reputable name met safety standards, but none of those unbranded or with minor names did, despite bearing the mark; non-compliant devices were actually potentially unreliable and dangerous, presenting electrical and fire hazards.
There are also cases in which the product complies with the applicable requirements, but the form, dimensions, or proportions of the mark itself are not as specified in the legislation.
Domestic plugs and sockets
Directive 2006/95/EC, the “Low Voltage” Directive, specifically excludes (amongst other things) plugs and socket outlets for domestic use which are not covered by any Union directive and therefore must not be CE marked. Throughout the EU, as in other jurisdictions, the control of plugs and socket outlets for domestic use is subject to national regulations. Despite this, the illegal use of CE marking can be found on domestic plugs and sockets, particularly so-called “universal sockets”
A logo very similar to CE marking has been alleged to stand for China Export because some Chinese manufacturers apply it to their products. However, the European Commission says that this is a misconception. The matter was raised at the European Parliament in 2008. The Commission responded that it was unaware of the existence of any “Chinese Export” mark and that, in its view, the incorrect application of the CE marking on products was unrelated to incorrect depictions of the symbol, although both practices took place. It had initiated the procedure to register CE marking as a Community collective trademark, and was in discussion with Chinese authorities to ensure compliance with European legislation.
There are mechanisms in place to ensure that the CE marking is put on products correctly. Controlling products bearing CE marking is the responsibility of public authorities in member states, in cooperation with the European Commission. Citizens may contact national market surveillance authorities if the misuse of the CE marking is suspected or if a product’s safety is questioned.
The procedures, measures and sanctions applying to counterfeiting of the CE marking vary according to the respective member state’s national administrative and penal legislation. Depending on the seriousness of the crime, economic operators may be liable to a fine and, in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given an opportunity to ensure that the product is in conformity with the applicable legislation before being forced to take the product off the market