How to obtain CE marking
There are a series of steps outlined below. Depending upon your product and the nature of the risks it presents:
- Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
- Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
- Choose the conformity assessment procedure from the options 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:
- Select the applicable product standards and test methods for your product and select a Notified Body.
- 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.
- 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.
- 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.
- 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.
IMPORTANT NOTE: This information is only for initial guidance. There may be additional requirements to comply for which it is necessary ot get complete information from corresponding EU official web site.
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