CE Approval Guide for Manufacturers <3>
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.
Product groups
Cableway installations designed to carry persons
Legislation
If your product(s) fall(s) within the sector of cableway installations Regulation (EU) 2016/424 on cableway installations applies.
- Regulation (EU) 2016/424 on cableway installations and repealing Directive 2000/9/EC
- For more information on Regulation (EU) 2016/424 please visit the webpage on cableways
- See more on harmonised European standards for cableway installations
Verify requirements
The New Approach legislation for CE marking has been designed by the European Union in such a manner that it covers all requirements for products from each of the aforementioned sectors.
Regulation (EU) 2016/424 defines ’cableway installations' as "a whole on-site system, consisting of infrastructure and subsystems, which is designed, constructed, assembled and put into service with the objective of transporting persons, where the traction is provided by cables positioned along the line of travel". These can be, for example, funicular railways, gondolas and chair lifts or drag lifts. Article 2(2) lists the installations not covered by the Regulation.
The essential requirements are listed in Annex II to the Regulation.
Need for notified body?
Before proceeding with the conformity assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.
In the case of cableway installations the assistance of a Notified Body is obligatory.
A Notified Body verifies the compliance of subsystems and safety components by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance.
When the Notified Body is convinced that the product is compliant, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up the Declaration of Conformity (DoC) to declare on his sole responsibility conformity to the relevant legislation. The establishment of the 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 harmonised 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.
To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please use NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by legislation or by country via the NANDO homepage.
Check conformity
The Regulation on cableway installations specifies in detail the requirements and for subsystems and safety components, it offers different modes of assessing product conformity in order for the manufacturer to affix the CE marking.
Before a subsystem or a safety component is placed on the market, the manufacturer shall submit the subsystem or the safety component to a conformity assessment procedure in accordance with Article 18(2). The details of the different conformity assessment procedures for subsystems and safety components are set out in Annexes III to VII to the Regulation: EU-type examination - production type, conformity to type based on quality assurance of the production process, conformity to type based on subsystem and safety component verification, conformity based on unit verification and conformity based on full quality assurance plus design examination. The manufacturer must then draw up and sign the EU Declaration of Conformity.
Technical documentation
Requirements regarding technical documentation for the different conformity assessment procedures are set up under Annex VIII to the Regulation.
Affix CE marking
Once the necessary steps have been successfully completed, the CE marking must be affixed to the safety component.
The marking must 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:
If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.
The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. This minimum dimension may be waived for small-scale safety components.
The CE marking shall be followed by the last two figures of the year in which it was affixed and by the identification number of the Notified Body that deals with the conformity assessment procedure.
When the product is subject to other legislation covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to that other legislation.
However, when one or more of those laws allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity only with the legislation applied by the manufacturer. In this case, the particularities of the legislation applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the legislation and accompanying such products.
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