Are you the authorised representative of a manufacturer in the EU? And does the manufacturer put products (non-food) on the market with your help? Then you must meet the requirements for product safety.
What is a representative?
An authorised representative (AR) is a company or person inside the EU who takes care of certain administrative tasks on behalf of a manufacturer. This is usual when a manufacturer wants to start selling a new product in the EU, but does not have a branch office inside the EU. The manufacturer can assign an authorised representative to perform the administrative tasks required to meet the EU legislation on product safety. For some products, a branch office inside the EU is a requirement. For example, for manufacturers who want to put machinery, toys, and personal protective equipment on the EU market. The manufacturer can appoint an authorised representative inside the EU to this end. Manufacturers who do have a branch office inside the EU can also appoint an authorised representative.
Put your contact details on the product
You must state your contact details on the packaging, on the product itself, or in a document that comes with the product. This makes it possible for consumers or supervising authorities to contact you with any questions they have about the product. Does a supervising authority ask you about the product? Then you must give them the information.
Required duties of an AR
An authorised representative is only allowed to perform the administrative tasks that have been agreed upon beforehand in writing. The manufacturer remains responsible for how the product is made (the manufacturing process). And for the product’s safety. The manufacturer has to authorise you to perform these tasks:
- Inform the supervising authorities: If a supervising authority requests information about the safety of a product, you must provide it. This concerns the product’s EU declaration of conformity and the technical file. You must retain the technical dossier for at least 10 years.
- Help to prevent risks: Are consumers who use the product at risk? For example, if they use the product in a different way than intended, might they get injured? Then you must help the supervising authorities to prevent those risks.
- Report risks yourself: Do you think there are risks involved in the use of a product? You must report this to the supervising authorities on the EU Safety Gate platform.
- Extra duties for an AR: A manufacturer can also authorise you to perform additional administrative tasks. For example, placing CE marking. Or drawing up an EU conformity declaration of conformity.
Stricter rules for medical aids
Are the products medical aid devices from outside the European Economic Area? In that case, you as AR have more responsibilities. You are the first point of contact for the supervising authorities for these products. And you must retain the technical dossier for 20 years, instead of 10.
Extra duties for an AR
What is outside the AR’s scope?
Because the manufacturer remains responsible for the product’s safety, you are not allowed to:
- Alter production or manufacturing processes
- Draw up technical dossiers
- Hire specialist help