The UK is now classed as a ‘third country’ from the EU’s perspective. This means that UK product manufacturers and importers are no longer considered to be ‘economic operators’ established in the EU. As a result, any distributors operating in the EU must now take on specific obligations for the purposes of product legislation. Should a UK manufacturer wish to sell products into Europe, they must find someone to take on various obligations, whether that is their distributor or an authorised representative.
What is an authorised representative?
An authorised representative (AR) is an individual or a business entity that acts as an authorised point of contact on behalf of a manufacturer that is based outside the country in which the product is being sold.
Is it mandatory to appoint an authorised representative?
If you are selling certain types of products into the EU, particularly medical devices, then yes, an appointment is mandatory. In any event, appointing an AR is a sensible approach from a practical perspective, especially if you do not have your own office in an EU member state, as an AR will act as a point of contact ‘on the ground’.
What are the new obligations for distributors and authorised representatives?
In a nutshell, the obligations that your distributors or ARs will have to abide by include:
- Ensuring that the correct conformity assessment procedure has been carried out by the manufacturer
- Ensuring that all technical documentation has been created and the product contains the relevant conformity marking such as a CE / UKCA marking
- Ensuring that all instructions have been printed and provided in a language relevant to where consumers and end-users are based
- Ensuring a point of contact (name and address) is placed on the product or its packaging
Can I still appoint several distributors if I have already appointed an authorised representative?
Yes, and in fact the AR themselves can also be an importer/distributor of your products.
As a non-EU manufacturer you will only need to appoint one AR across the entire EU, whereas you may have several distributors and/or sales agents.
Do I need to inform anyone that I have appointed an authorised representative?
Yes. The AR’s details (name and contact details) must be printed on the packing/labelling of the products to be sold into the EU. This is required by EU legislation as the AR is the person or entity placing the product onto the market – this will allow market surveillance or regulatory authorities to contact that person or entity, if necessary.