CE marking providers in Bengalore

1. What is CE marking?

The CE mark is the mandatory declaration by the manufacturer that the product meets the safety requirements set by the applicable EU legislation and that the appropriate conformity assessment procedures have been completed.

What does CE stand for?

It may be reasonable to think that CE stands for Communauté Européenne, meaning European Community in French, or Conformité Européenne (European conformity) but officially it is simply a logo.

What does the CE mark look like?

In general, the CE mark must appear on products but it may also appear on packaging, in manuals or other supporting literature. The CE mark must take the form below, which can be reduced or enlarged, but the proportions must be maintained. The height of the letters must not be less than 5mm. It should be noted that the C and the E are not perfect semi-circles.

What products need to be CE marked?

Products included:

New products manufactured in the 27 member states, Iceland, Liechtenstein and Norway

New, used and second-hand products imported from third countries

Products that have been subject to important changes and therefore may be considered as new products

Products excluded:

Products that have been repaired without changing the original performance, purpose or type

Products specially or exclusively intended for military or police purposes

Who is responsible for placing CE marking on the products?

It is the responsibility of the manufacturer to verify whether or not a product falls within the scope of one or more of the directives listed on page 3 and 4, and to have those products marked. Where the products are imported from countries outside the European Economic Area (EEA), this responsibility falls on the importer within the community.

Which countries require products to be CE marked?

The CE marking must be placed on a product before it is launched within the European Economic Area (EEA), i.e. 27 EU member states plus Iceland, Liechtenstein and Norway. The CE marking is mandatory even if the product was manufactured outside these countries but it is not required for exporting a product to non-EEA countries. According to the free movement of goods principle within the EU, member states may not forbid, restrict or impede the placing on the market of products. Bearing the CE mark, unless the provisions relating to CE marking are incorrectly applied, or there is a hazard that is not covered by the applicable directives.

Who carries out the conformity assessment of a product?

The conformity assessment is carried out either by the manufacturer through self-declaration, or by notified bodies. Notified bodies are organisations appointed by each member state to carry out the conformity assessment procedures referred to in the applicable directive(s) when third party intervention is required. To be eligible as a notified body the organisation must:

Be a legal entity established on the territory of the member states

Have the necessary personnel and equipment available

Be independent and impartial in relation to those directly or indirectly concerned with the product

Have technical competence of personnel that is relevant to the products and conformity assessment procedure in question

Maintain professional secrecy and integrity

Subscribe to civil liability insurance, unless that liability is covered by the state under national law.

What would happen if a product was not CE marked?

Enforcement varies according to the national administrative and penal laws. If there is no safety risk, the relevant enforcement authority may provide the manufacturer with another opportunity to ensure that the product is correctly CE marked before being obliged to take the product off the market. The manufacturer may also be liable to a fine and/or imprisonment.

2. Products that need CE marking

Below is the list of European directives that provide for CE marking and the links to their texts. Each directive defines the products that are within its scope. Manufacturers should study the directive(s) in order to decide whether their products need CE marking. Products not covered by the scope of these directives may not bear the CE mark.

Directive 2006/95/EC Low voltage equipment

Directive 87/404/EEC Simple pressure vessels

Directive 88/378/EEC Safety of toys

Directive 89/106/EEC Construction products

Directive 2004/108/EC Electromagnetic compatibility (EMC)

Directive 98/37/EC Machinery

Directive 89/686/EEC Personal protective equipment (PPE)

Directive 90/384/EEC Non-automatic weighing instruments

Directive 90/385/EEC Active implantable medical devices

Directive 90/396/EEC Appliances burning gaseous fuels

Directive 92/42/EEC Hot-water boilers fired with liquid or gaseous fuels

Directive 93/15/EEC Explosives for civil uses

Directive 93/42/EEC Medical devices

Directive 94/9/EC Potentially explosive atmospheres (ATEX Directive)

Directive 94/25/EC Recreational craft

Directive 95/16/EC Lifts

Directive 97/23/EC Pressure equipment

Directive 98/79/EC In vitro diagnostic medical devices

Directive 99/5/EC Radio equipment and telecommunications terminal equipment

Directive 2000/9/EC Cableway installations designed to carry persons

Directive 2004/22/EC Measuring instruments

Directive 96/57/EC Household electric refrigerators, freezers and combinations thereof

Directive 2000/14/EC Noise emission in the environment by equipment for use outdoors

Directive 2000/55/EC Ballast for fluorescent lighting

N.B. Please note that Directive 99/36/EC on transportable pressure equipment does not provide for CE marking but for another conformity marking, which looks like the Greek symbol π (see Annex VII of the Directive).

3. Advantages of CE marking

There are a significant number of advantages of CE marking for the manufacturer and for the consumer. In particular:

CE marking provides manufacturers with market access to the whole European Economic Area, since countries within this area may not restrict the placing on the market of products bearing the CE marking.

It guarantees that the product conforms to the regulations in the specific directive(s)

It is a guarantee for the manufacturer that the product is safe for consumers

It may significantly reduce damage claims and liability premiums.

4. Procedure to CE mark a product

Once the European directive(s) that are applicable to a particular product have been identified, the product has to go through the following process:

1.     Conformity assessment procedure

The essential objective of a conformity assessment procedure is to ensure that products placed on the market conform to the requirements as expressed in the provisions of the directives, in particular with regard to the health and safety of users and consumers. Conformity assessment is subdivided into modules which relate to the design phase of products, their production phase, or both. The eight basic modules (modules A to H) and their eight possible variants can be combined in a variety of ways to establish complete conformity assessment procedures.

The European directives that provide for CE marking establish different procedures, according to the categories of products covered. A list of the eight basic modules, their eight possible variants and the different conformity assessment procedures by directive can be found in annexes 7 and 8 of the European Commission’s ‘Blue Guide’ on CE marking:

http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm

Application of standards

The manufacturer must ensure the product complies with all the essential requirements of the directive(s). It is therefore helpful to establish whether there are any harmonised European Standards applicable to the product. These are not mandatory standards for manufacturers, although there is a presumption that this will conform to the essential requirements of the Directive. Whenever possible or appropriate, manufacturers should follow harmonised standards. A list of harmonised standards by directive can be found at:

http://www.newapproach.org/Directives/DirectiveList.asp

Documentation needed

Technical documentation: this technical file (drawn up by the manufacturer) is intended to provide information on the design, manufacture and operation of the product, and to demonstrate the conformity of the product to the applicable requirements set by the specific directive(s).

Declaration of conformity: it states the conformity of the product with the requirements of the directive. It also allows an enforcement authority to identify who is responsible for a product and what that person claims to have done to CE mark it. The declaration of conformity must contain all relevant information to identify the Directive(s) according to which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, the product and, where appropriate, a reference to harmonised standards or other normative documents.

Other documents: the manufacturer must check that no other national requirements exist in the countries where the product will be sold. These may include national standards, labelling or packaging requirements.

Contact us for CE Marking on: 09718380800, 9999974494