CE Certification

Posted on September 10, 2011. Filed under: ISO, ISO 13485, medical, medical devices, orthopedics, sampling plan, sampling plan for the medical devices, webhosting |

CE marking (also known as CE mark) is a mandatory conformance mark on many products placed on the market in the European Economic Area (EEA). With the CE marking on a product the manufacturer ensures that the product is in conformity with the essential requirements of the applicable EC directives.[1] The letters “CE” stand for “Conformité Européenne” (“European Conformity”).

Meaning

Existing in its present form since 1993, the CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, on ones sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area. This also applies to products made in third countries which are sold in the EEA.

CE marking does not indicate that a product was made in the EEA,[3] but merely states that the product is assessed before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonised level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant “essential requirements” (e.g. safety, health, environmental protection requirements) of the applicable directive(s) – or, if stipulated in the directive(s), had it examined by a notified conformity assessment body.

However, not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked. CE marked products are bought not only by professionals (e.g. medical devices, lifts, machinery and measuring equipment) but also by consumers (toys, PCs, mobile phones and light bulbs).

Rules underlying CE marking

The manufacturer of a product himself affixes the CE marking to it, but has to take certain obligatory steps before the product can bear CE marking. He has to carry out a conformity assessment, set up a technical file and sign an EC declaration of conformity. The documentation has to be made available to authorities on request.

Importers of products have to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request. Importers should also make sure that contact with the manufacturer can always be established.

Distributors must be able to demonstrate to national authorities that they have acted with due care and must have affirmation from the manufacturer or importer that the necessary measures have been taken.

If importer or distributor market the products under their own name, they then take over the manufacturer’s responsibilities. In this case they must have sufficient information on the design and production of the product, as they will be assuming the legal responsibility when they affix the CE marking.

There are certain rules underlying the procedure to affix the marking:

* Products that are subject to certain EC directives providing for CE marking, have to be affixed with the CE marking before they can be placed on the market

* Manufacturers have to check on their sole responsibility, which EU directives they need to apply for their products

* The product may only be placed on the market if it complies with the provisions of all applicable directives and if the conformity assessment procedure has been carried out accordingly

* The manufacturer draws up an EC declaration of conformity and affixes the CE marking on the product

* If stipulated in the directive(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure

* If the CE marking is affixed on a product, it can only bear additional markings under the condition that they are of different significance, do not overlap with the CE marking and are neither confusing nor impairing the legibility and visibility of the CE marking

Self-certification

Depending on the level of risk of the product, the CE Mark is affixed to a product by the manufacturer or authorized representative who decides whether the product meets all the CE mark requirements. If a product has minimal risk it can be self certified where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product. In doing this the manufacturer has to do several things:

1. Decide whether the product needs to have a CE mark and if the product applies to more than 1 directive it needs to comply with all of them.
2. Choose the conformity assessment procedure from the modules called out by the directive for the product. There are several modules available for the Conformity Assessment Procedures as listed below:

* Module A – Internal production control.
* Module A – Intervention of a Notified Body.
* Module B – EC type-examination.
* Module C – Conformity to type.
* Module D – Production quality assurance.
* Module E – Product quality assurance.
* Module F – Product verification.
* Module G – Unit verification.
* Module H – Full quality assurance.

These will often ask questions about the product to classify the level of risk and then refer to the “Conformity Assessment Procedures” chart. This shows all the acceptable options available to a manufacturer to certify the product and affix the CE mark.

Products which are considered to have a greater risk have to be independently certified by a notified body. This is an organization that has been nominated by a Member Government and has been notified by the European Commission. These notified bodies act as test labs and carry out the steps as listed in the directives mentioned above and then decided whether the product has passed. A manufacturer can choose their own notified body in any member state of the European Union but should be independent of the manufacturer and a private sector organization or a government agency.

Declaration of conformity

The DoC must include: manufacturer’s details (name and address, etc.); essential characteristics the product complies; any European standards and performance data; if relevant the identification number of the Notified Body; and a legally binding signature on behalf of the organization.

Product groups

The EC directives for CE marking[4] affect the following product groups:

* Active implantable medical devices
* Appliances burning gaseous fuels
* Cableway installations designed to carry persons
* Eco-design of energy related products
* Electromagnetic compatibility
* Equipment and protective systems intended for use potentially explosive atmospheres
* Explosives for civil uses
* Hot-water boilers
* In vitro diagnostic medical devices
* Lifts
* Low voltage
* Machinery
* Measuring Instruments
* Medical devices
* Noise emission in the environment
* Non-automatic weighing instruments
* Personal protective equipment
* Pressure equipment
* Pyrotechnics
* Radio and telecommunications terminal equipment
* Recreational craft
* Safety of toys
* Simple pressure vessels

Misuse

Proximal location of CE mark and Made in China text. The European Commission is aware that CE marking, like any other mark, is misused. CE marking may sometimes be affixed to products which do not fulfil the requirements and conditions for its affixing or it is affixed to products for which the affixing is not foreseen. There are also cases where, whilst the product is in compliance with the applicable requirements the CE marking itself does not respect the formal requirements, namely the form of the CE marking or the dimensions and proportions prescribed in the legislation.

China Export

The CE symbol has been alleged or believed to stand for China Export or China Electronics because some Chinese manufacturers apply a very similar marking to their products.As Chinese exporters have used the CE logo incorrectly, the matter was raised at the EU parliament in 2008,and the Commission responded that they will look into trade-marking the logo, and are in discussion with Chinese authorities to ensure compliance with European standards.

Legal implications

There are mechanisms in place to ensure that the CE marking is put on products correctly. Controlling CE marked products is the responsibility of public authorities in the Member States, in cooperation with the European Commission. Citizens may contact national market surveillance authorities if the misuse of the CE marking is suspected, or if a product’s safety is questioned.

The procedures, measures and sanctions applying to counterfeiting of the CE marking vary according to the respective Member State’s national administrative and penal law. Depending on the seriousness of the crime, economic operators may be liable to a fine and in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given a second opportunity to ensure that the product is in conformity with the applicable legislation, before being obliged to take the product off the market.

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