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 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 this role.

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.

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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.

 

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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.

Initial Set Up Charge for first family  £300.00 $480.00 (USA)
Set Up Charges for additional families £ To Be Agreed
Annual Fee for up to three product families £1,250.00 $2,000.00 (USA)
Annual Fee for each additional product family £ To Be Agreed
Additional fee when we are Notified to the Competent Authority £250.00 $400.00 (USA)

 

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Atlantic Bridge Limited, Atlantic House, PO Box 4800, Earley, Reading, Berkshire, RG5 4GB, England. Email: info@atlanticbridge.co.uk 
Telephone : +44 (0) 118.969.7047 Fax : +44 (0) 118.901.4411  Devizes Office Telephone : +44 (0) 1380.848170 Fax : +44 (0) 1380.840152

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