UK REPRESENTATION

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

Requirements for Responsible Person (Medical Devices) and Authorised Representative (Non-Medical equipment)

The UK regulations require the manufacturer to use a Responsible Person or an Authorised representative based in the UK. The UK is no longer a member of the EU and an agreement needs to be implemented to appoint such a representative.

The UK Responsible Person or Authorised representative will be limited to the UK unless they are located in Northern relens where regulations are different.

Sometimes this Representative is the importer or sales agent.

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 Responsible Person or Authorised representative in the UK for UKCA Marking.

We hold copies of your documentation as set out in the regulations 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 Medical equipment, regular updates to the registration of your Compnay, Importers, and  products on the MHRA DORS Databse do incur on-going costs, for more information please contact us.

In many instances, e.g. All Medical Devices, your Responsible Person has to register you with the MHRA on the DORS System and has legal responsibilities under the Directives. The Responsible Person may be required to counter-sign your Declaration of Conformity and or be part of your Quality Management Assessment. In addition Atlantic Bridge Limited has to register your business on the MORE database and manage any incdients or vigilance issues on your behalf.

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.

The 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.

The new Medical Device regulations places more responsibility onto the Responsible P-erson (Formerly Authorised Representative). Please ensure you understand the role we are taking before fnalising the agreement..

Language

Sales to th UK 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.

Fees

We provide the service of Responsible Person or Authorised Representative for a set annual charge.

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 as recorsd have to be maintained on the MHRA DORS systemwhich often requires a fee to be made for additions and updates.

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