The
CE Mark is a mandatory European marking for certain product
groups to indicate conformity with the essential heath and
safety requirements set out in European Directives. The
letters ¡®CE¡¯ are an abbreviation of Conformite Europeenne,
French for European conformity. The CE Marking of products
as ¡°passport¡± which can allow a Manufacturer to freely
circulate their products within the European market place.
The CE Mark declares that your product complies with the
Essential Requirements of the applicable EU Directives.
Applicable requirements are set forth in various European
Directives that replace individual country safety standards.
The Directives apply to products manufactured within but
also exported to the European Union.
The CE Mark is placed on a product as the manufacturer¡¯s
visual identifier that the product meets the requirements
of relevant European Directives. It is mandatory for a wide
range of products sold within or exported to the European
market.
To
facilitate free trade and ensure the safety of certain products,
European countries have developed a series of standards,
or Directives as they are called. Compliance is mandatory.
It is a legal obligation on the part of the manufacturer
or his agent. Penalties for failing to get CE-Marking for
a product can be severe.
If you wish to sell your products within the European Union
member states and the European Economic Area, the product
in question must comply with the Directive(s). This also
applies if you are a manufacturer who wants to export products
into the European Member countries.
The Directives replace individual country standards as they
relate principally to the safety of these products.
What
products do the Directives cover?
The Directives apply to a wide range of products. The most
notable products that likely need CE-marking are:
- pressure
equipment
-
machinery of almost any description
- electrical
and electronic equipment
-
medical devices and equipment
-
personal protective equipment
-
equipment for use in potentially explosive environments
There
are certain exclusions, but if you manufacture any of the
above types of equipment or products then one or more of
the Directives almost certainly apply.
EU
Directives
Directives apply to 99% of all industrial and domestic
products sold in Europe; it is the distinctive CE mark that
signifies compliance with the applicable Directives. Without
the CE mark and the correct documentation, manufacturers
and importers are at an immediate disadvantage when competing
against compliant competitors.
Complying
with Directives
The requirements of the Directives are to ensure that manufacturers
have identified and addressed all aspects of design and
manufacturing that could impact safety and the safe operations
of the equipment.
The
actions required to become compliant with the Directives
vary according to which Directive(s) apply and the type
or classification of the equipment as defined by the Directive(s).
However, there are some general steps you should follow:
1.Determine
which, if any, EU Directives apply to your product(s),
2.Determine the extent to which your product already complies
with the essential requirements of the Directives.
3.Choose conformity assessment routes. Depending on the
nature of the equipment or product, you may be able to implement
and declare compliance and affix the CE mark without assistance
or service from an external company.
A
Notified Body is an independent body appointed by an agency
within one of the European countries, usually governmental,
as being capable of performing the duties of a Notified
Body as defined by the Directives.
