What does CE marking indicate on a product?
By placing CE marking on a product the manufacturer is responsible for product compliance with essential requirements set forth in relevant legislation or technical regulations foreseeing its placement. Products bearing CE marking are presumed to be in line with technical regulations, and as such they can be launched and made available on the Albanian and European market.
Are the products bearing CE marking always manufactures in EU countries?
No. CE marking only indicates that all essential requirements have been met when the product was manufactured. CE marking is not an indication of origin. Therefore, a product bearing CE marking could be manufactured across the world.
Are all the products bearing CE marking tested and approved by relevant authorities?
No. The conformity assessment of products with legal requirements applied to these products is the sole responsibility of the manufacturer. The manufacturer places CE marking and drafts the EC declaration of conformity. The performance of conformity assessment by a third part, i.e. a European notified body or its branch registered in Albania and approved by relevant minister, is requested only for products of high risk for public interest, such as pressure vessels, lifts, etc.
Can I, as a manufacturer, place CE marking in my products?
Yes, CE marking is always placed by the manufacturer or his/her authorized representative themselves, after carrying out necessary conformity assessment procedures. This means that before placing CE marking on a product and launching it on the market, it should be subject to conformity assessment procedure set forth in one or more technical regulations. The technical regulations set forth whether conformity assessment can be performed by the manufacturer himself/herself or whether the intervention of a third party (approved body) is required.
Where CE marking should be placed?
CE marking should be placed on a product or its data. In case this is not possible due to product nature, CE marking should be placed in the packing and/or its accompanying document.
What is EC declaration of conformity?
The EC declaration of conformity is a document in which the manufacturer or his/her authorized representative indicates that the product is compatible with legal requirements applicable a specific product. The EC declaration of conformity s drafted / translated in Albanian language and should contain the name and address of the manufacturer or his/her authorized representative, together with information about the product, such as product unique identification number, brand, etc. The EC declaration of conformity should be signed by an individual working with manufacturers or their authorized representative, specifying the employer’s role.
The manufacturer is the sole responsible person for the EC declaration of conformity drafting and signing, regardless of the fact whether a European notified body or its branch registered in Albania is involved or not.
Is CE marking mandatory, and if yes for which products?
Yes, CE marking is mandatory for those products this marking has been set forth in Albanian technical regulations, which are harmonized with EU directives.
Examples of products covered by Albanian technical regulations harmonized with EU directives, which set forth CE marking, are toys, electrical equipment, machineries, personal protective equipment and lifts. Products not covered by the legislation on CE marking should not bear CE mark.
The information on products bearing CE marking and EU directives on CE marking is available in the following link:
http://ec.europa.eu/growth/single-market/ce-marking/index_en.htm
In addition, the Albanian technical regulations setting forth CE marking are available in the website of State Inspectorate of Market Surveillance (SIMS).
Which is the difference between CE marking and other markings, and can other markings be placed on a product if it does not bear CE marking?
CE marking is the only marking indicating that a product meets all the requirements set forth in technical regulations for that product. A product can bear additional markings on the condition that they must not diminish CE marking visibility, legibility and meaning. Therefore, other markings can be used only if they contribute to improve consumer protection and are not covered by technical regulations.
Who is responsible for the correct use of CE marking?
The surveillance of legal provisions implementation on CE marking is a responsibility of market surveillance responsible structures.
What obligations does the placement of CE marking introduce to manufacturers/authorized representatives/importers/distributors?
The manufacturer or his/her authorized representative, as well as importers and distributors play an important role on the launching on the market of only safe products in compliance with relevant legislation. Not only this ensures a sufficient level of life, human health, environment and public interest protection, but it also supports fair competition with all players subject to the same rules.
The manufacturer or his/her authorized representative is the sole responsible person to ensure product compliance with the requirements set forth in relevant legislation and CE marking placement. The manufacturer drafts the technical documentation and carries out relevant conformity assessment procedures. He/she draft the EC declaration of conformity and places CE marking. The manufacturer keeps the technical documentation and EC declaration of conformity after the product launching on the market.
The importer launches only safe products on the Albanian market. He/she ensures that the product he/she imports has the technical documentation and CE marking. In case the importer has doubts that the product he/she imports does not comply with the requirements set forth in legislation, he/she must should not launch the product on the market. When a product poses risk, the importer informs the manufacturer and SIMS. He/she keeps a copy of the EC declaration of conformity for as long as it is defined in relevant regulations. Importers have the obligation of placing on the product the trade name and address where he/she could be contacted. In addition, they should ensure that the product is accompanied by use/maintenance guides and information on safety in Albanian language. The importer should ensure that contact with manufacturers is always possible.
Distributors also play an important role in the supply chain to guarantee that products launched on the market are compatible with legislation, and should act with due diligence to make sure that the product handling by their side has no negative impact on its compliance with legal requirements. Before launching a product on the market, the distributor should verify that the product bears required marking and is accompanied by complete necessary documentation. Otherwise, he/she should not launch the product on the market and should inform the manufacturer or importer and SIMS.
If the importer or distributor markets products under his/her name, then he/she takes on the manufacturer’s responsibilities.
In that case, he/she should have sufficient information on product design and manufacturing, since he/she takes legal responsibility by the moment CE marking is placed.

What is conformity assessment?
Conformity assessment is a process through which the manufacturer demonstrates that the product is in compliance with specific legal requirements set forth in technical regulations. The product is subject to conformity assessment during design and manufacturing.
The conformity assessment should not be confused with market surveillance. The market surveillance is carried out by state authorities (state inspectorates) after the product is launched on the market. Conformity assessment is a responsibility of the manufacturer before the launching on the market.
Conformity assessment is a responsibility of the manufacturer. However, when required by specific legislation, the conformity assessment body should be included in that process.
A conformity assessment body means each body conducting conformity assessment activities, including calibration, testing, certification and inspection.
An approved body means any conformity assessment body approved by the minister responsible to perform specific duties of conformity assessment in compliance with provisions of the law on marketing and market surveillance. The minister approves only accredited bodies.
In case when technical regulations stipulate the involvement of conformity assessment body for CE marking, they can be only European notified bodies or their branches registered in Albania and approved by responsible minister.
Who are the actors involved in conformity assessment process?
The actors involved in this process are as follows:

 1.Legislator, who

• Sets forth legal requirements that the product should meet
• Specifies the conformity assessment modules from the list defined in the law on marketing and market surveillance

   

2.Manufacturer, who

• Designs, manufactures and tests the product
• Drafts product technical documentation
• Takes all necessary measures to ensure product compliance
• Upon the demonstration of product compliance with applicable requirements, he/she drafts EC declaration of conformity and places CE marking or conformity marking
• Upon third party intervention, he/she fixes the identification number of approved body

3.Conformity assessment body, which

• Conducts control and assessment in line with applicable requirements
• Upon a positive assessment, it issues the certificate of approval as required in specific legislation

For complete information about European notified bodies classified by European Union member states and by group of products, please see NANDO database.
http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.main
 

What is conformity assessment?
Conformity assessment is a process through which the manufacturer demonstrates that the product is in compliance with specific legal requirements set forth in technical regulations. The product is subject to conformity assessment during design and manufacturing.
The conformity assessment should not be confused with market surveillance. The market surveillance is carried out by state authorities (state inspectorates) after the product is launched on the market. Conformity assessment is a responsibility of the manufacturer before the launching on the market.
Conformity assessment is a responsibility of the manufacturer. However, when required by specific legislation, the conformity assessment body should be included in that process.
A conformity assessment body means each body conducting conformity assessment activities, including calibration, testing, certification and inspection.
An approved body means any conformity assessment body approved by the minister responsible to perform specific duties of conformity assessment in compliance with provisions of the law on marketing and market surveillance. The minister approves only accredited bodies.
In case when technical regulations stipulate the involvement of conformity assessment body for CE marking, they can be only European notified bodies or their branches registered in Albania and approved by responsible minister.
Who are the actors involved in conformity assessment process?
The actors involved in this process are as follows:

1.Legislator, who

• Sets forth legal requirements that the product should meet

• Specifies the conformity assessment modules from the list defined in the law on marketing and market surveillance

2.Manufacturer, who

• Designs, manufactures and tests the product

• Drafts product technical documentation

• Takes all necessary measures to ensure product compliance

• Upon the demonstration of product compliance with applicable requirements, he/she drafts EC declaration of conformity and places CE marking or conformity marking

• Upon third party intervention, he/she fixes the identification number of approved body

3.Conformity assessment body, which

• Conducts control and assessment in line with applicable requirements

• Upon a positive assessment, it issues the certificate of approval as required in specific legislation

For complete information about European notified bodies classified by European Union member states and by group of products, please see NANDO database.
http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.main