CE marking and machines

 

CE marking of machinery

 

The CE marking has been introduced into the legislation of the European Union as a means of eliminating barriers to the movement of goods and also to protect the interest of the public.

The CE marking has been introduced to machines by Directive 93/68/EEC Directive which introduces harmonized relating to 'CE' marking provisions.

Affixed to the machinery and products, this marking indicates that the product complies with all essential requirements of safety and health guidelines for which the product claims compliance.

This mark allows free trade and movement of goods within the European Union and European Economic Area (EEA), ie the 27 Member States.

By affixing the CE marking on the product, the manufacturer (or his representative), declares under it sole and exclusive liability that the productmeets ALL legal and regulatory requirements allowing it to affix the CE marking. This provision also applies to manufacturers of products manufactured in countries outside the EU and sold within the EEA.

For example the machinery directive 2006/42/EC, we subsection " recitals "

(20) Manufacturers should retain full responsibility for certifying the conformity of their machinery to the provisions of this Directive. Nevertheless, for certain types of machinery having a higher risk factor, a stricter certification procedure is desirable.

The main directives that apply to industrial products are:

  • Directive 2006/42/EC (which replaces the directives 98/37/EC and 89/392/EEC )
  • 2006/95/EC Low Voltage Directive of 12 December 2006 (which replaces Directive 73/23/EEC)
  • Directive 94/9/EC of 23 March 1994
  • General Directive 2001/95/EC on the safety of products
  • EMC Directive 2004/108/EC of 15 December 2004 (which replaces Directive 89/336/EEC of 23 May 1989)

Also, the Directive on personal protective equipment - (89/686/EEC)

  • Most industrial products are covered by one or more of these guidelines.
  • The CE marking is carried out before the placing on the market of products and results of a conformity assessment procedure to be conducted by the manufacturer. The manufacturer, its agent or the importers and distributors, therefore have legal obligations to fulfill.
 

The legal obligations of the manufacturer for CE marking procedure

Concepts and definitions manufacturer, agent, importer or distributor mentioned in the directives.

When the body of the directive is too old, a new text: the Regulation (EC) No 765/2008   defined in Article 2 and notins these definitions.

3. ‘manufacturer’ shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark;
4. ‘authorised representative’ shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation;
5. ‘importer’ shall mean any natural or legal person established within the Community who places a product from a third country on the Community market;

6. ‘distributor’ shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

The requirements of the Directives set all controls and documents that the manufacturer must perform in order to assess and ensure product compliance with the requirements of applicable directives. The entire evaluation procedure leads to:

1) the affixing of the CE marking graphics defined in Directive 93/68/EEC and Annex III of machinery Directive 2006/42/EC

2) preparation of technical documentation.

(24) It is essential that, before drawing up the EC declaration of conformity, the manufacturer or his authorised representative established in the Community should prepare a technical construction file. However, it is not essential that all documentation should be permanently available in material form, but it must be possible to make it available on request. It need not include detailed plans of subassemblies used for the manufacture of machinery, unless knowledge of such plans is essential in order to ascertain conformity with the essential health and safety requirements.

 

3) EC declaration of conformity whose content is defined in Annex II to the EC Machinery Directive 2006/42/EC

In terms of legislation, this document "Declaration of conformity" confirms that the whole procedure of conformity assessment has been respected and that the test results are satisfying the EESH and standards requirements.

Manufacturer (established in the EU or outside the EU) may also designate a representative who must be established in the EEA that it runs on its behalf the certification process as defined above.


Notified bodies

In some cases and for some machines, the conformity assessment may involve a third party: a notified body.

Notified bodies are appointed by the Member States. These organizations are listed in the database NANDO (New Approach Notified and Designated organsations - notified body designated under the new approach).

For example, the Machinery Directive 2006/42/EC, Annex IV of the Directive defines the machines where the intervention of a notified body is required.

An indicative list of the notified bodies for machines defined in the list of notified to the Machinery Directive 2006/42/EC organizations. This list is indicative and was hjour upon publication on the industry-finder site.

The official list is available on the website of the European Union: europa . For each directive, there are different notified bodies may not cover all directives.

Each directive of the European Union provides the categories of products and machines for which the intervention of a notified procedure for conformity assessment is required Organization.

For ATEX and Machinery Directive, the information contained in the body of the directive.

However, attention in the case of an appeal to a notified bodies, the manufacturer remains responsible :

  • to affix the CE marking,
  • to establish the EC declaration of conformity
  • to assume responsibility for the compliance of the product.

 


Legal requirements related to CE marking - Obligations for importers and distributors

Machines from third-party (non-EU) can be sold within the EEA. The products are also under the scope of the CE marking.

The importer must ensure that the machines they place on the market comply with European legislation applicable to these products.

Importers must ensure that non-EU manufacturers have followed the procedure of certification and documentation is also available.

They must have knowledge of the regulatory and legislative aspects for the content of different directives field that allows them to know what documents must be provided, which products must have the CE mark and be able to estimate the obvious non-conformities.

Above all, they must have a written proof of the manufacturer ensuring their access to the following required documents:

  • EC declaration of conformity
  • technical documentation.

They also need a written proof of the manufacturer that authorize them to communicate and transmit these documents to the national authorities on request.

If an importer or distributor placing on the market a product in its own name, it assumes all the responsibilities of the manufacturer and shall assume legal liability for the affixing of the CE marking


Presumption of conformity: the use of harmonized standards

To remove differences in legislation between countries, the European Union and the directives set basic requirements of health and safety. These are the essential requirements of health and safety that the manufacturer must respecter.Un important standardization work has been undertaken in recent years at the CEN, CENELEC and ETSI, and a means to prove compliance with the essential requirements health and safety is to prove the conformity of the product or machine to harmonized standards.

For Directive 2006/42/EC, the list of harmonized standards is published regularly.

'' The use of harmonized standards the certification process gives presumption of conformity.

Attention, the use of these standards is not mandatory. These standards are intended to represent the state of the art of technology. If a manufacturer wants to use another way, he is free. He must in that case prove that he obtains a level of safety and performance at least equivalent to the one described in the harmonized standard.


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