The as “Harmonized Standards”. Harmonized Standards are

The letters ‘CE’ refers to the French
abbreviation “Conformité Européene”
and it may appear on many products that are traded on the extended
Single Market in the European Economic Area (EEA).  This marking is referred as the CE Marking.
The EEA composed of the EU countries along with Iceland Liechtenstein, Norway
and Switzerland.

CE Marking presence on a product referred
as the declaration of the manufacturer that the product meets the standards and
legal requirements to be marketed on the EEA. This condition also applies to
the products from the other countries which are to be sold in the EEA Market. The
CE Mark implies that the products sold in the single Market of EEA have
complied to meet all safety, health and environmental protection requirements. Any
products bought within the EEA possess the CE mark on them. CE marking in a way
promotes fair competition on the market as all companies are accountable to the
same rules 16. The manufacturer or the manufacturer himself is responsible
for verifying compliance with the directives and affixing the CE marking shown
in Figure 3?1.

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Figure 3?1 CE Marking

 

“The main benefits that the CE marking brings
to the businesses and consumers within the EEA are:

·        
Businesses know that products
bearing the CE marking can be traded in the EEA without restrictions.

·        
Consumers enjoy the same level
of health, safety, and environmental protection throughout the EEA”. 16

 

To affix the product with the CE Mark the
Manufacturers follows the set of documents from the European Union known as
Product Directives.  Product
Directives are the documents
that contain requirements and regulation the product should
comply with. Not all products should be affixed with the CE marking. It is
compulsory only for the products that need to be marketed within EEA and
covered by the Product Directives. The product directives are classified based
on the industrial sector the product being used. It is forbidden to affix CE
marking to the products that does not fall under any product directives.
Depending on the nature of the product the product falls under one or more than
one product directives. Product directives consist of a rules and regulation
for the product to be manufactured. Some product directives which cover large
product ranges provide a set of standards for the product should conform; these
standards are referred to as “Harmonized Standards”.   Harmonized Standards are the documents that
list the technical specifications and test methods to verify the products to
conform to the technical specification. 
Harmonized Standards are established by several European standards
agencies (CEN, CENELEC, etc). 16

CE Marking also provides some advantages on
the single market area of EEA making it simpler for the trading of products in
the market. The marking on a product indicates the governmental officials of
any country to verify that the product is legally or illegally placed on the
market of their country. CE Marking on a product ensures the free
movement of the product within the Single market area providing equal
opportunities and equal standards to the Manufacturers and safe market to the
consumers. CE Marking on a product also promotes the permission of withdrawal
of the non-conforming products by EEA Customs. 16

1.1       Manufacturers

As CE
Marking sole purpose is have a single market area with products of good quality
and safety standards. The manufacturers play an important role in ensuring that
products placed on this Market of the EEA meets those standards. They are
responsible for ensuring that the products from them which are placed on the
market meet the standards of EU safety, health, and environmental protection
requirements.

To ensure
the product with EU standards, manufacturers have to carry out the conformity
assessment and issue the EU declaration of conformity before affixing the CE
marking to a product. Only after the conformity assessment, the technical file
of the product can be set up which supports the EU conformity declaration so
that this product can be traded on the market. The conformity assessment can be
done by the manufacturer themselves or by a notified body which is appointed by
the national authorities.

“Manufacturers have to follow these six
steps to affix a CE marking to your product:

Identify the applicable directive(s) and harmonised
standards.
Verify the specific requirements for the product.
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.” 18

The above steps may differ according to the
product as the conformity assessment procedure of the products varies mostly.  Manufacturers should not affix CE marking to
other products that does not fall under any of the directives as it is
forbidden to do so.

 

1.2       Conformity assessment

The main objective of the European
Commission is to ensure that the unsafe and non-compliant products should not
enter the European Market. The conformity assessment is the process to ensure
the standards of the product. The conformity assessment procedure is carried
out on the product before the product enters the market. This procedure should
provide the requirements that are met by the product. The assessment comprises
of the testing, inspection and providing the technical certification of the
product for the conformity. The test methods and procedure of the assessment
are specified in the applicable harmonized standards of the product. The
manufacturer can choose the procedure types from the directives if applicable.
The assessment can be done by the manufacturer or by an independent
organization known as notified bodies which are appointed by the national
authorities 19.

 

If the manufacturers carry out the
assessment by themselves, the most used assessment method is internal
production control which is given as follows.

·        
Accessing and ensuring the list
of directives and standards for the product.

·        
Create the requirements that
should be fulfilled by the product.

·        
Create of the test plan and
procedures according to the harmonized standards.

·        
Testing and verification of the
product with requirement.

·        
Create Technical file or
Technical documentation for the Conformity.

·        
Manufacturers draw up a written
EU declaration of conformity to the authorities.

·        
Affix a proper CE Marking to
the product according to the EU Commission.

” The technical documentation that supports
the conformity of the product varies with some products but the following
documents are the most important in the technical documentation:

·        
A general description of the
device, sometimes including photographs showing external features, Software
versions, user information and installation manuals.

·        
Designs, manufacturing drawings
and plans of components, assemblies, circuits

·        
Descriptions and explanations
necessary for the understanding of the drawings, plans and functioning

·        
A list of harmonized standards
applied for the products in full or in parts.

·        
Results of design calculations
and tests

·        
Test reports.” 22, p.102