CE Approval Guide for Manufacturers <5>
Manufacturers play a crucial role in ensuring that products placed on the extended single market of the European Economic Area (EEA) are safe. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.
If you are a manufacturer, you have to follow these 6 steps to affix a CE marking to your product:
- Identify the applicable directive(s) and harmonised standards
- Verify product specific requirements
- Identify whether an independent conformity assessment (by a notified body) is necessary
- Test the product and check its conformity
- Draw up and keep available the required technical documentation
- Affix the CE marking and draw up the EU Declaration of Conformity (27 KB).
These 6 steps may differ by product as the conformity assessment procedure varies. Manufacturers must not affix CE marking to products that don’t fall under the scope of one of the directives providing for its affixing.
For products that present higher safety risks such as gas boilers, safety cannot be checked by the manufacturer alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. The manufacturer may affix the CE marking to the product only once this has been done.
Active implantable medical devices
Appliances burning gaseous fuels
Cableway installations designed to carry persons
Ecodesign of energy related products
If your product(s) fall(s) within the sector of energy-related products, it (they) might be subject to Directive 2009/125/EC on the Ecodesign of energy related products (the 'ecodesign directive'):
- Directive 2009/125/EC on the ecodesign of energy related products
- Factsheet: Ecodesign your future
- For more information on Directive 2009/125/EC on ecodesign, please also visit the ecodesign webpage
- See more on harmonised standards for the ecodesign of energy related products
Other directives may additionally apply depending on specific products.
The New Approach Directives for CE marking have been designed by the European Union in order that they cover all requirements in their field of application for products from each of the aforementioned sectors.
The Ecodesign Directive (2009/125/EC) is a framework directive that sets the ecodesign requirements related to the environmental parameters that manufacturers have to meet in order for their products to carry the CE marking.
Directive 2009/125/EC covers products which have an impact on energy consumption during use, including products, which use, generate, transfer, or measure energy, and other energy-related products such as windows, insulation materials, or certain products which consume water, all of which could contribute to significant energy savings during use.
The directive’s concern is to reduce the overall environmental impact of products, including resource consumption and emission of pollutants by focusing on the principles of sustainable development in a product’s entire lifecycle.
The directive’s additional scope is to ensure the free movement of the concerned products within the internal European market. The directive does not apply to means of transport for persons or goods.
The methodology and the procedures for setting ecodesign requirements are specified in the directive (i.e. Annexes 1 and 2 for product specific design and construction requirements).
Need for notified body?
Before proceeding with the assessment procedure, it is important to clear whether you, the manufacturer, can assess your product by yourself or whether you have to involve a notified body.
The need for involving a notified body is determined in the specific implementing measures adopted under the Ecodesign Directive 2009/125/EC.
A notified body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the notified body is involved in the production control phase, its identification number will follow the CE marking.
When the notified body is convinced of product’s compliance, it issues a certificate of conformity to confirm this. Then the manufacturer draws up a declaration of conformity (DoC) to declare that it is his sole responsibility to ensure conformity to the relevant directive. The establishment of a DoC is a legal obligation.
The declaration of conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the notified body as well as a legally binding signature on behalf of the organisation. For further details please consult your specific directive.
To find the notified bodies appointed by the Member States to carry out conformity assessment, the manufacturer should consult the NANDO database – the New Approach Notified and Designated Organisations. They can search for notified bodies by directive or by country via the NANDO homepage.
The conformity assessment procedures the manufacturer can choose from are specified by the implementing measures. In principle, the implementing measures leave the manufacturer the choice between an internal design control and a harmonised standard management system. The management system must conform to the product-related requirements and include the design function. Regardless of whether a notified body has been involved or not, the manufacturer must draw up and sign an EC Declaration of Conformity.
Products, which have been awarded a European eco-label, are the exception, as they are presumed to comply with the eco-design requirements of the applicable implementing measure.
The implementing measures
Implementing measures are mandatory requirements in the form of regulations, which come into force without further implementation into national laws. The European Commission, after consulting the Member States, market stakeholders and other interested parties, selects product groups in the so-called working plan. New product groups are selected for the working plan every 3 years. Preparatory studies mandated by the European Commission compile specific data for each product group that serve as background information for the development of appropriate minimum requirements. On the basis of the preparatory studies, the European Commission develops requirements for the environmental performance of the selected products or product groups. The Ecodesign Directive prioritises self regulations by manufacturers as an alternative to Regulations insofar they respect the criteria given in the directive. So far, the following implementing measures have been published:
1. Regulation No 1275/2008 eco-design requirements for standby and off-mode electric power consumption of electrical and electronic household and office equipment
2. Regulation No 278/2009 eco-design requirements for no-load condition electric power consumption and average active efficiency of external power supplies (amending 1275/2008)
3. Regulation No 244/2009 eco-design requirements for non-directional household lamps (amended by 859/2009)
4. Regulation (EC) No 859/2009 ultraviolet radiation of non-directional household lamps (amending 244/2009)
5. Regulation No 245/2009 eco-design requirements for fluorescent lamps without integrated ballast, for high intensity discharge lamps, and for ballasts and luminaries able to operate such lamps, and repealing Directive 2000/55/EC of the European Parliament and of the Council
6. Regulation No 107/2009 eco-design requirements for simple set-top boxes
7. Regulation (EC) No 640/2009 eco-design requirements for electric motors
8. Regulation (EC) No 641/2009 eco-design requirements for glandless standalone circulators and glandless circulators integrated in products (text with EEA relevance)
9. Regulation (EC) No 642/2009 eco-design requirements for televisions
10. Regulation (EC) No 643/2009 eco-design requirements for household refrigerating appliances
Upon successful assessment, the Ecodesign Directive 2009/125/EC requires technical documentation as laid out in Annex V. The technical documents must enable assessment of the conformity of the appliance with the requirements of the Directive. The technical file should comprise
- A general description of the product and of its intended use
- The results of relevant environmental assessment studies carried out by the manufacturer or alternatively references to environmental assessment literature or case studies, which have been used by the manufacturer in evaluating, documenting and determining product design solutions
- The ecological profile, where required by the implementing measure
- Documents describing the results of measurements on the eco-design requirements carried out
- The manufacturer must establish specifications indicating, in particular, which standards were or were not applied and ultimately, what means have been used to ensure compliance
- A copy of the information concerning the environmental design aspects of the product provided in accordance with the requirements (specified in Annex I, Part 2)
- A copy of the EC declaration of conformity
The manufacturer or his authorised representative is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed into the market.
Affix CE marking
Once the necessary steps have been successfully completed, the logo must be affixed to the product.
The marking has to be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials ‘CE' taking the following form:
The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.
When the product is subject to other directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other directives.
However, when one or more of those directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking has to indicate conformity with the directives applied by the manufacturer only. In this case, the particularities of the directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the directives and accompanying such products.
If a notified body is involved in the production control phase, its identification number must be also displayed.
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