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Most "equipment" or "products" imported into the European Union (EU) are required to be declared as being compliant with one or more European Union Directives that control their safety or environmental performance. For many this requires the affixing of the CE marking and issuing a Declaration of Conformity. Here we aim to answer some of the most frequently asked questions.
What is a CE mark?
A CE marking is a specific mark, usually of a minimum of 5mm high that must be fixed to a product, literature or to its packaging, prior to its sale in the European Union.
What types of products does CE marking requirements cover?
There are twenty-one Directives that require the affixing of the CE marking.
The following are just some of the items that come under the requirements of the different Directives:
Where do I find a list of the European Directives?
Click Here for a comprehensive list.
How do I demonstrate compliance for my products?
First it is necessary to determine which Directives apply to the product. Based on the choice of Directive(s) manufacturers should then choose the best route to demonstrate compliance. This will depend on the product type. For many products this will be testing to the requirements of detailed EU accepted standards (known as harmonised standards), or European Norms (EN's) which will detail exactly what is required of the product and how testing will be performed. For some products, typically those of a technical or higher risk nature, where no harmonised product standard requirements exist an approved organisation (notified body) may have to be approached to confirm the compliance of the product - more on this subject can be found on the Applications of Standards page.
How do I find out if my product is covered by a harmonised standard?
You may contact Eurolink (Europe) and we will advise you.
What if my product is not covered by a harmonised standard?
This depends on the type of product you wish to sell. All Directives require compliance to be declared with their Essential Health & Safety Requirements (EHSRs). If there are no standards that can be used then evidence based on detailed analysis of compliance with the EHSRs must be assembled. Some Directives require that this evidence is confirmed by a Notified Body. Where the services of a Notified Body are prescribed they will not be able to support you legally but may provide advice on the appropriate compliance route to take. Alternatively contact Eurolink (Europe).
What is a Notified Body and where can I find such an organisation?
Notified Bodies are independent organisations who are assessment bodies or test laboratories by the EU Member States to perform the conformity assessment tasks specified in individual Directives. Manufacturers and exporters may choose to use the services of a Notified Body from any member state.
A list of all European Union Notified Bodies can be found at: http://ec.europa.eu/enterprise/newapproach/nando
My products are not manufactured in the European Union. How can I ensure that I am complying fully with all the applicable laws and documentation requirements?
You should consider using the services of an Authorised Representative – further details can be found on our Authorised Representative page.
What can happen if I sell products into the European Union that are not CE marked or which do not meet the requirements of the Directives?
The penalties can be severe and may include, restriction or prohibition of sales, forfeit of the entire product range or in serious cases a fine, or a combination of these. To find out more visit our Legal Liabilities page. To find out how to avoid this situation, visit our Authorised Representative page.
What requirements are there in addition to the preparation of a Technical File demonstrating compliance?
To import products into the EU there are specific rules regarding documentation and possibly registration – further details can be found on our Declarations of Conformity page.
These are just some of the more common questions regarding the CE marking process.
To find out more or to receive a rapid and comprehensive answer to a more specific question please contact us.
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