CE marking

The Single Market

At the beginning of 1992, the European Single Market was
created. The objective was to remove barriers to trade throughout the European Economic Area
allowing companies free access to markets in all the different countries
without having to meet particular local requirements such as safety testing
regulations, customs tariffs or contract conditions. Potentially, manufacturers
now have access to a market with a spending power even larger than North America.

The Directives

In the period up to 1992, and subsequently, the European
Parliament has enacted a series of measures intended to put the Single Market
into practice. Some of these Directives have
been aimed at removing barriers of a purely customs/excise nature, others have
concentrated on transport arrangements to ensure the free movement of goods,
while a series of Directives (produced under the heading of `New Approach
Directives) are intended to provide controls on product design, with the
principal objective being to provide a `level playing field' for product safety
requirements across the European Community.

The directives cover a very wide range of product areas. One of the first to be
implemented concerned the safety of children's toys. Subsequent directives have
included provisions for machinery, electromagnetic compatibility (EMC),
personal protective equipment, medical devices, gas appliances and commercial
explosives, among others. Also relevant is the Low Voltage
Directive. Strictly speaking the LVD, which was first enacted in 1973, pre-dates
the New Approach directives, but subsequent amendments have given it a very
similar function and legal structure, and the amendment which introduced the
requirement to CE mark products recognised that the LVD should broadly be
treated as if it were a New Approach directive.

Product assessment and quality control

The primary function of the New Approach directives is to
ensure that products are sufficiently well designed and built that they will be
fit for the purpose for which they are sold and that reasonable precautions are
taken to protect the user against injury while the product is being used. The
Directives recognise that different product categories require different
precautions; for instance the Low Voltage
Directive generally only requires that products be designed to comply with
the relevant international safety standards and while an independent check that
the standards have been complied with is often advisable, it is not mandatory
and manufacturers are free to declare their products safe without the need for
independent testing. The Machinery
Directive, on the other hand, requires that for certain
categories of equipment a third party independent check be made by a test
house notified
for the purpose by the Government. The most stringent requirement, which
applies to certain products covered by the Personal Protective
Equipment Directive and to the Gas Appliances
Directive, is that not only should the product undergo an independent type
test, but that it also has to be manufactured using a quality management system
which has been assessed to ISO9000.

Protection requirements, administration requirements.

Directives essentially contain two distinct sets of
requirements. The first, the protection requirements, are the parts of
the directive which lay down the safety requirements which must be met in order
to comply with the directive. Different directives go into different levels of
detail on these points, but the full requirements are never contained in the
directive itself - this is left to product
standards which are developed by multinational committees made up from the
national standards organisations of all countries in the EU.

The administrative requirements are the part of the directive which lays
down how the manufacturer (or their agent) must CE mark
the product. The manufacturer must produce a declaration
of conformity stating that the product meets the requirements of the
directives which apply to it, and the standards or other references which were
used to judge that it complies. Usually there is also a requirement to produce
and maintain a file of design and manufacturing information, known as a
technical file or technical construction file, which shows how the product was
designed and built to meet the requirements of the directive. The Directive may
lay down time limits during which the manufacturer must keep the technical
file, even after the end of a product's market life.

It should be noted that, before the product can be CE marked, it must comply
with all the directives which apply to it.

The CE Mark

The CE mark
must be affixed to (in order of preference) the product, its instruction manual
or to its packaging. Recent guidance from the European Commission indicates
that the mark must appear on the product itself unless there are good technical
reasons why it cannot. It must be at least 5 mm high. It is not intended to be
a mark of quality - rather it is intended to indicate to the authorities
responsible for enforcing the Directives that the product's manufacturer claims
compliance with the directives which apply to the product.

The act of fixing the mark to the product, and signing the Declaration of
Conformity, constitutes a declaration by the manufacturer that the product
meets the requirements of all the Directives which apply to it. The onus is
very much on the manufacturer to take responsibility for this actually being
true. Marking a product which is not fully in accordance with the requirements
of the applicable directives is an offence in its own right, and would also
contravene related consumer safety and trades descriptions legislation.

Implications for manufacturers

The purpose of the directives is not to ban any products from the European
Single Market, unless the product is very poorly made or is unsafe. For most
reputable manufacturers, complying with the essential protection requirements
of the directives is not particularly onerous and companies which have always
taken a responsible attitude to the performance and design of their products
will have few problems complying with the New Approach directives.

Where a manufacturer is based outside the EU, it is the person who is
responsible for bringing the equipment across the first EU border who has legal
responsibility for CE marking it. However, because of their intimate
involvement in the safety of the product, manufacturers almost always have some
responsibilities under the CE mark directives even if they are not directly
responsible for importing the goods into the EU.

Where the manufacturer has a formally appointed
distributor or subsidiary ('authorised
representative') the situation is reasonably straightforward. Where a piece
of equipment is imported for the use of the importer, things get more complex
and each case must be considered on the basis of the individual circumstances.

Where there may be difficulties is in the administrative requirements since
these will require a new way of working for some manufacturers and suppliers,
particularly small businesses. Manufacturers may well find it cost effective to
seek outside help in the early stages of complying with the Directives in order
to save time and prevent expensive mistakes. However, it is important to be
aware that it is rarely necessary to commit to an expensive program of testing
and modifications: unless the Directives which apply to the product
specifically require the involvement of a third party for product approval or
quality system assessment, the manufacturer can affix the mark without having
to involve a test house, consultant, the DTI or anyone else.

Further advice

As with all CE marking directives, the actual requirements for any piece of
equipment under the directive are complex and dependent on not only the design
but also the type of user, the intended use and sometimes even what is claimed
in the instructions or sales literature.

For further advice specific to your products, please contact us at
Conformance and we will be pleased to discuss your needs. If you'd like us
to prepare a no-obligation quote for assisting you with CE marking your
products, please take a look at our page which gives details of the information required in order
to be able to give you an accurate idea of the costs and procedures involved.

23 April 2001