EU Representation

Atlantic Bridge Limited logo

European Regulatory Support for Business since 1995
We can be your Authorised Representative in the E.U.
CE Marking, Health & Safety . . .
Risk Management, Product Safety . . .

WE CAN PROVIDE THE NECESSARY HELP TO ENSURE YOU MEET THE REQUIREMENTS 
FOR AUTHORISED REPRESENTATION IN THE EU.

 

Requirements for Authorised Representative

Most of the CE Marking Directives require the manufacturer to use an authorised representative in the EU.

Sometimes this Representative is the importer or sales agent or the EU Local Office.

Often non-European companies will sell direct through agents who are not able to tie in the company to the requirements of the Directives.

Atlantic Bridge Limited can take on the role of Authorised representative.

We hold copies of your documentation as set out in the Directives and hold it available for the statutory authorities. As this is not a Sales Function there is no % taken of your sales just a flat annual fee for a number of products.

In many instances, e.g. Class 1 Medical Devices, your Authorised Representative is notified to the Competent Authority and has legal responsibilities under the Directives. The Authorised Representative may be required to counter-sign your Declaration of Conformity and or be part of your Quality Management Assessment.

We manage this process and liaise with the relevant Competent Authority to display compliance. This requires a regulatory agreement a copy of which has to be passed to the Competent Body for Approval for Medical products and has to be in place for other products.

Th contact details of your Authorised Representative must be displayed either on the product or on user documentation issued with the product dependent on the product. For ADVICE PLEASE CALL US.

 

Language

Sales to EU States must include certain documentation in the language of the user. By using Atlantic Bridge Limited and provided your mother tongue is English, you will not need further translation for the main controlled documentation.

For supplies to non-English speaking EU Countries, Atlantic Bridge Limited can provide translations as necessary.

 

Fees

We provide the service of Authorised Representative for a set annual charge for up to three different product families.

There is an initial set up charge for us to check the documents provided if we were not previously employed to help you to assemble them. If there are shortfalls discovered we would not be able to accept the role of Authorised Representative until such shortfalls were corrected. We can provide help to assist you to correct these shortfalls if necessary.

A Separate annual fee is chargeable where we have to be "Notified" to the statutory authority. This mainly applies to Medical Devices.

Please contact us with product details in order that we can give you a competitive firm price.