Authorised Representatives are companies established in the United Kingdom appointed by a manufacturer to perform specific duties on the manufacturer’s behalf. Such companies can, for example, communicate with UK authorities.
Some product regulations indicate that it is voluntary for manufacturers to appoint an authorised representative. Other regulations, such as The Medical Devices Regulations 2002, require manufacturers to hire an authorised representative – or “UK responsible person” – if they are established outside the United Kingdom.
Note that the requirements for appointing an authorised representative in Northern Ireland are different because they remain aligned with EU regulations and directives.
This guide answers some common questions concerning authorised representatives, using The Toys (Safety) Regulations 2011 and The Medical Devices Regulations 2002 as the basis.
Content Overview
FREE CONSULTATION CALL (US, EU & UK)
- Request a free 30-minute call with Ivan Malloci to learn how we can help you with:
- Find product requirements
- Certification and labeling
- Lab testing
What is an authorised representative?
An authorised representative is a UK-based company appointed in writing by the manufacturer to perform agreed-upon specific tasks, such as keeping a copy of the technical documentation and providing information to the authorities upon request.
For some regulations, such as The Toys (Safety) Regulations 2011, appointing an authorised representative is voluntary in Great Britain (that is, England, Wales, and Scotland).
On the other hand, some regulations, such as The Medical Devices Regulations 2002, require manufacturers established outside the United Kingdom to appoint a UK responsible person to perform certain tasks if they sell medical devices in Great Britain.
As we will explain later in this article, in Northern Ireland the requirements are different, due to the fact that the country is aligned with EU rules.
Note that there are limits on what an authorised representative can do. For example, they cannot be responsible to ensure that a given product is manufactured according to essential requirements, as this obligation fall on the manufacturers.
When is an authorised representative required to sell products in the United Kingdom?
The authorised representative requirements differ depending on the product, regulation, and market. This section explains how the requirements apply in Great Britain. We use The Toys (Safety) Regulations 2011 and The Medical Devices Regulations 2002 as case studies.
The Toys (Safety) Regulations 2011
The Toys (Safety) Regulations 2011 indicate that toy manufacturers – established both in the UK or abroad, – may voluntarily appoint an authorised representative.
The authorised representative should carry out some of the toy manufacturer’s obligations, such as:
a. Retain the technical documentation and the Declaration of Conformity for 10 years
b. Provide the authorities, upon request, with a copy of the technical documentation
c. Comply with requests regarding eliminating toy-related risk
However, we have no indication that there exist cases in which appointing an authorised representative is mandatory.
The Medical Devices Regulations 2002
The Medical Devices Regulations 2002 require manufacturers based outside the United Kingdom to appoint a “UK responsible person” when they sell their products in Great Britain.
Per the regulations, a UK-responsible person needs to carry out the tasks listed in regulation 7A(3):
a. Ensure that the manufacturer draws up the declaration of conformity and technical documentation and carries out the applicable conformity assessment procedure
b. Keep a copy of the technical documentation and make it available to the authorities upon request
c. Prove a device’s conformity by providing the Secretary of State with the necessary documentation and information
d. Provide samples of, or access to, the medical device upon the Secretary of State’s request
e. Inform the manufacturer about the Secretary of State’s request to provide samples of, or access to, the devices (when it has no access). The authorised representative should subsequently inform the Secretary of State whether the manufacturer means to comply with said request
f. Prevent or correct, by eliminating or mitigating, any risks posed by the medical devices
g. Inform the manufacturer immediately of any complaints made by users, patients, and healthcare professionals regarding the medical devices
h. Cancel the contract with the manufacturer – and inform the Secretary of State and the approved body – of that cancellation if the manufacturer fails to comply with the regulations
When is an authorised representative required to sell products in Northern Ireland?
Northern Ireland is generally aligned with the EU’s product safety requirements. In order to sell your products in Northern Ireland, you need to follow the authorised representative requirements set by the following EU regulations:
In short, you need to appoint an authorised representative for most products sold in Northern Ireland if:
- Your company is selling directly to consumers, and
- Your company is not based in Northern Ireland nor in the European Union
According to the guidance page published on GOV.UK concerning the EU General Product Safety Regulation, the authorised representative must be based in either the European Union or Northern Ireland.
Do non-UK companies need an authorised representative to sell to consumers in the UK?
As far as we know, non-UK manufacturers of most products are not obligated to appoint an authorised representative when they sell their products in Great Britain. Some regulations allow you the option of appointing an authorised representative for certain specific tasks (e.g. to keep the technical documentation).
However, manufacturers of some other products, such as medical devices, are required to appoint a responsible person when they are not based in the UK.
The Toys (Safety) Regulations 2011
We could not find any obligation to appoint an authorised representative in The Toys (Safety) Regulations 2011. The regulations, however, specify that manufacturers may do so voluntarily.
The Medical Devices Regulations 2002
The Medical Devices Regulations 2002 require medical device manufacturers not based in the United Kingdom to appoint a UK responsible person when they sell their products in Great Britain.
How can I find an Authorised Representative in the UK?
Many businesses offer authorised representative services in the UK. Here are some examples:
- International Associates
- ProductIP
- Authorised Rep Compliance
- Obelis UK
You can find more companies in this guide.
