How to obtain
CE Marking for my product ?
How to achieve CE mark approval, CE testing and meet all CE mark
requirements, for my product?
There are a series of steps outlined below for CE mark approval. Depending upon your
product and the nature of the risks it presents:
1. Determine if any directives apply to your product. If more than one applies you
will have to comply with all of them.
2. Determine the extent to which your product complies with the essential
requirements for design and manufacturing in the applicable directive(s).
3. Choose the conformity assessment procedure from the options (modules) called
out by the directive for your product. There are several modules available for the
Conformity Assessment Procedures as listed below:
Module A: internal production control
Module Aa: 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
The directives often use a series of questions about the nature of your product to classify
the level of risk and refer to a chart called "Conformity Assessment Procedures". The
chart includes all of the acceptable options available to a manufacturer to certify their
product and affix the CE Marking.
Minimal Risk
Options for products with minimal risk include self certification where the manufacturer
prepares a Declaration of Conformity and affixes the CE Marking to their own product.
Greater Risks
Many directives require products/systems with greater risks to be independently
certified; this must be done by a "Notified Body". This is an organization that has been
nominated by a Member Government and has been notified by the European
Commission. Notified bodies serve as independent test labs and perform the steps called
out by directives. They must have the necessary qualifications to meet the testing
requirements set forth in the directives. Notified bodies may be a private sector
organization or a government agency. Manufacturers may choose a notified body in any
member state of the European Union. Lists of notified bodies are published by the
European Commission in the Official Journal of the European Communities.
A Notified Body is usually able to offer some of the services required:
product testing
type examination certificate issue
Technical File and design dossier evaluation
surveillance of product and quality system
identification of standards
If your products need to be certified by a Notified Body, then you will need to do
as the follows:
1. Select the applicable product standards and test methods for your product and
select a Notified Body.
2. Establish an Authorized Representative in the European Union for your
product.
Some directives require that a manufacturer designate in the European Union an
authorized representative to produce Technical Documentation (or sometimes
called Technical File) in a timely fashion when called upon to do so. The CE
Marking itself is not meant to provide details about the product to Surveillance
Authorities.
Technical Documentation (Technical File): The directives require for many
products that a Technical Documentation (Technical File) be prepared by the
manufacturer. The Technical Documentation (Technical File) holds information
that verifies that the testing was conducted properly and that the product complies
with applicable standards.
3. Prepare a Declaration of Conformity.
The Declaration of Conformity must contain information adequate for tracing the
product back to the manufacturer or the authorized representative in the European
Union. It may include a list the directives and standards that your product
conforms to, product identification, the manufacturer's name, address and
signature.
4. Register your product in EU
Many products, for instance, Class I Medical Devices, are required to be
registered in the EU and, if proved, get a Certificate of Registration. Without this
Certificate of Registration, the products are NOT allowed to be affixed with the
CE Marking and be placed on the market.
5. Affix the CE Marking to your product.
There are specific rules to adhere to for the CE Marking. These rules address the
size and location of the Marking; affixing the CE Marking to products, packaging
and material or documents shipped with the product; and specific limitations on
when and who is permitted to affix the CE Marking.
