An authorised representative takes on tasks for a manufacturer within the Union, but not all of them. Article 9 of Regulation (EU) 2016/425 draws a clear line, and the mandate has to reflect it.
The role is voluntary. Article 9(1) says a manufacturer may appoint an authorised representative. Unlike medical devices, for instance, there is no obligation to do so.
A factory in China produces protective gloves for the European market. Authorities and customers expect a contactable point in the Union that can produce the documentation. The manufacturer appoints a company established in the EU in writing.
Important: responsibility for the design and for the technical documentation remains with the Chinese manufacturer. The authorised representative keeps the documentation available, they do not produce it.
A US group manufactures hearing protection and sells it through its German subsidiary. The parent is the manufacturer within the meaning of the Regulation, the subsidiary is appointed as authorised representative and handles market surveillance enquiries in Europe.
Two roles often coincide here. If the same subsidiary also imports the goods, it is at the same time the importer under Article 10 and carries those verification duties.
Specialised companies offer the function of EU authorised representative commercially, often for several foreign manufacturers at once. For the manufacturer that is the quickest route to an address in the Union.
Whether it holds up depends on the mandate. A service provider holding hundreds of mandates does not know your product. When it matters, what counts is what was agreed in writing.
The order follows the text of the Regulation so that you can look up every point there.
The appointment is made in writing. What cannot be transferred is the obligation to design in conformity under Article 8(1) and the drawing up of the technical documentation under Article 8(2). Both remain with the manufacturer.
Keep the EU declaration of conformity and the technical documentation available for the market surveillance authorities for ten years from the date the PPE was placed on the market.
On reasoned request from an authority, hand over all information and documentation demonstrating conformity.
Cooperate with the authorities on measures to eliminate risks, as far as your own area of responsibility is concerned.
Most mandates are worded too vaguely. They name an authorised representative without settling which tasks are actually transferred. Once an objection arrives, it is then disputed who has to answer for what. That clarification belongs at the beginning, not in the emergency.
Each item bookable on its own. Prices on request after the initial call.
Examining which tasks can be transferred and which have to remain with the manufacturer.
Checking whether the declaration of conformity and the technical documentation are complete and current.
Support with reasoned requests from market surveillance.
What the mandate covers and what it does not, prepared so that your team can follow it.
Holding several roles at once is the normal case.
Four questions to establish which role applies to you.Describe your product and your role. Afterwards you will know which obligations actually apply to you and where the pitfalls are. No obligation.
