Does your organisation need a Authorised Representative  or a Responsible Person in the UK?

If you want to sell a CE marked product in the  UK and do not have a base there - then the answer is probably YES

Most of the UK regulations require the manufacturer to use an Authorised Representative who is based in the European Union for most products supplied against product regulations.

A Responsible Person is required if you supply medical equipment to the UK.

This Authorised Representative and or Responsible Person will, as set out in the regulations:

  • Hold copies of your documentation
  • Have copies available for inspection by statutory authorities
  • Under some directives such as Medical Devices, the  Responsible Person is notified to the competent authority and has legal responsibilities under the UK Regulations
  • In some circumstances the Authorised Representative may be required to counter-sign your Declaration of Conformity and or be part of your Quality Management Assessment

Here at Atlantic Bridge Limited we can take on the roles of Responsible Person and / or Authorised Representative as we have doen in the past under the "CE" marking regulations.

The list of UK regulations and comparable EU regulations for NON-MEDICAL is as follows:

 

N.B. The UKCA regulaions for ALL Medical devices is SI.2002:618