CE Approval Guide for Manufacturers <13>
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
Machinery
Directives
If your product(s) fall(s) within the sector Machinery, the Directive 2006/42/EC on Machinery applies:
Verify requirements
The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they fully cover all requirements for products from each of the aforementioned sectors.
Directive 2006/42/EC on Machinery specifies the essential health and safety requirements the product has to meet in order for the manufacturer to affix the CE marking
Directive 2006/42/EC covers machinery; interchangeable equipment; safety components; lifting accessories; chains, ropes and webbing for lifting purposes and removable mechanical transmission devices. It also includes requirements for partly completed machinery.
The first step a manufacturer should take to ensure that a machine will be compliant with the Directive is to carry out an assessment procedure, with regard to the essential requirements. This includes also to check which European Harmonised Standards are applicable, as a way to get presumption of conformity. A list of harmonised standards for machinery can be found on the European Commission’s Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs website.
Annex I to Directive 2006/42/EC sets out in detail the essential health and safety requirements for the products covered.
An amendment to the Directive was agreed in 2009 introducing new requirements for machinery for pesticide application, which must be designed and manufactured in such a way as to minimise the unintended dispersal of pesticides in the environment.
This amendment becomes applicable on 15 December 2011.
Please consult the Directive to ensure that your product complies with all the essential requirements. You can also download an extensive explanatory guide (3 MB) to the Directive, published in June 2010.
Need for notified body?
Before proceeding with the assessment procedure, it is relevant to clear whether you, the manufacturer, can assess your product by yourself or you have to involve a Notified Body.
Directive 2006/42/EC on Machinery foresees the involvement of a Notified Body if the product to be assessed falls in one of 23 categories listed under Annex IV and it does not conform to a European Harmonised Standard which covers all of the relevant health and safety requirement. In this case, the manufacturer has to seek assistance by a Notified Body. If it is not the case, the manufacturer himself carries out internal checks on the product.
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 compliance, issues a certificate of conformity to confirm this. Then the manufacturer draws up the Declaration of Conformity (DoC) to declare on his sole responsibility conformity to the relevant Directive. The DoC is legally binding.
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, if relevant. For further details please consult your specific Directive.
To find the Notified Bodies appointed by the Member States to carry out conformity assessment, look no further than NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.
Check conformity
For machinery that does not fall under one of the 23 categories listed in Annex IV to the Directive, the manufacturer himself carries out internal checks on the conformity of the product.
If a product falls under one of those 23 categories, the manufacturer has the option of carrying out internal checks on the product only if it conforms to a European Harmonised Standard which covers all of the relevant health and safety requirements. If it is not the case then the conformity of the product must be assessed through either the EC-type examination procedure (and additional internal checks) or the full quality assurance procedure. These procedures, carried out by Notified Bodies, are explained in Annexes IX and X to the Directive.
Either a Notified Body has been involved or not, the manufacturer draws up and signs the EC Declaration of Conformity.
Manufacturers are required to work with the market surveillance authorities in each country in which the machinery is placed on the market. To identify the relevant authority, manufacturers can refer to the contact person (137 kB) in the ministry in charge of implementing the Machinery Directive in each Member State.
Technical documentation
Upon successful assessment, Directive 2006/42/EC on Machinery requires a technical documentation as laid out in Annex II. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.
The technical file should comprise:
a detailed documentation on the construction of the machinery including drawings of the machinery and its parts,
test results,
description of protective measures
other elements as described in Annex VII, A(a).
Also, the file must contain a copy of the EC declaration of conformity.
The manufacturer must also provide documents for series production and internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive (Annex VII, A (b)).
The manufacturer must carry out the necessary tests on components, fittings or the completed machinery to determine whether it can be assembled and put into service safely. The relevant reports and results shall be included in the technical file.
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 can be affixed on the product.
The marking has to be placed visibly and legibly on the product or, if not possible because of 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 substantially the same vertical dimension, which may not be less that 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 only with the Directives applied by the manufacturer. In that case, 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 has been involved in the conformity assessment procedure, its identification number must also be displayed.
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