Frequently Asked Questions
Frequently Asked Questions
The European Union defines an Authorised Representative as being “…any natural or legal person established within the (European) Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation…”.
In effect, an EU Authorised Representative acts as a Manufacturer’s legal representative within the EU in relation to compliance with European Product Safety Directives and Regulations.
An EU Authorised Representative can also be known as a ‘Responsible Person’. It is often abbreviated to EUAR, EU Rep or EC Rep.
In most circumstances there is no mandatory requirement to appoint an EU Authorised Representative. If a Manufacturer is legally established within the European Union, it will never need to appoint an Authorised Representative. In all other cases, whether it is necessary to appoint an Authorised Representative will depend on which EU regulations are applicable to a Manufacturer’s products.
For example, under the EU’s regulations for Medical Devices (Regulation (EU) 2017/745) and In Vitro Diagnostic Devices (Regulation (EU) 2017/746), if a Manufacturer is not legally established within the European Union, it must appoint an EU Authorised Representative before it can place any products on the market.
In another circumstance, if a product falls within the scope of the EU’s EcoDesign requirements (Directive 2009/125/EC) and need to be registered on the EPREL database, that can only be done by either the Manufacturer if it is established in the EU, or by an Authorised Representative. Therefore, for Manufacturers with no established legal presence within the EU who need to register products on EPREL, it become mandatory to appoint an Authorised Representative.
Under EU regulations, an Authorised Representative is one of five recognised and defined types of Economic Operator.
The EU Market Surveillance Regulation 2019/1020 defines an Economic Operator as being ‘the Manufacturer, the Authorised Representative, the Importer, the Distributor, the Fulfilment Service Provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant (European) Union harmonisation legislation.
The precise scope of an EU Authorised Representative’s responsibilities will depend on the agreement between them and a manufacturer. However, as a minimum the EU authorities expect an Authorised Representative to do the following:
- Keep the EU Declaration of Conformity and the Technical Documentation at the disposal of national surveillance authorities and cooperate with them at their request,
- Upon a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product,
- Cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.
Other tasks may include:
- a Manufacturer and/or its products on an EU Database such as EPREL.
- Affixing the CE marking (and where relevant other markings) and, if required, a notified body’s number to a product,
- Drawing up and signing EU Declarations of Conformity.
Most EU Directives and Regulations regarding specific product types or technical requirements (e.g. Machinery, Pressure Equipment, Toys) will require that the name and physical address of the Authorised Representative is included on the Declaration of Conformity for a product.
Some EU Directives & Regulations will also include a requirement that the Authorised Representative is identified on a label or plate on the product itself.
If an Authorised Representative is acting as the Economic Operator for a product, the EU Market Surveillance Regulations will require the Authorised Representative’s details, including their name and address, to be clearly shown on either the product itself, on product packaging or on documentation accompanying the product. The information must be displayed when the product enters the EU Single Market.
Yes, as a minimum an Authorised Representative should be clearly identified on Declarations of Conformity issued for a Product and, when required by specific Directives or Regulations, on labelling affixed to the Product itself.
Yes, there must be a written agreement or ‘mandate’ between an Authorised Representative and their Client for the appointment to be considered valid. However, the precise wording of the agreement and the scope of the appointment can vary.
With BREXIT and the United Kingdom’s departure from European Union, the EU Directives and Regulations that required or allowed the appointment of Authorised Representatives no longer apply in the UK.
However, the UK Government has chosen to convert many of the existing EU Directives & Regulations into UK law, and in doing so have retained many of the concepts and requirements that go with them, including the concept of Authorised Representatives.
A UK Authorised Representative therefore fulfils the same function as an EU Representative, but for manufacturers placing their products on the UK market and in relation to the applicable UK statutory Regulations.
Yes, in both cases a Company can be an Authorised Representative. Under EU regulations a legal ‘Person’ can be an ‘association of persons’ such as registered company or another organisation. The same is the case for the UK.
For a Company to be an Authorised Representative it must be ‘established’ within the EU or UK, which in both cases means having one of the following:
- A registered office
- Central headquarters
- A permanent business establishment
Eurolink has established separate registered companies located in the UK and the Republic of Ireland respectively, allowing it to fulfil the requirements for being established in both the EU and UK and offer Authorised Representative Services in both territories.
Yes, an Authorised Representative can fulfil other functions, whether on behalf of the manufacturer or separately. For example, a Manufacturer could choose to appoint a local Distributor in the EU or UK to act as its Authorised Representative.
No, any party who holds the legal right to and responsibility for a product may appoint an Authorised Representative. For example, a Company that develops, markets and sells a product in its own name but outsources the product’s physical construction to a third-party may appoint an Authorised Representative to act on their behalf.
The European Union defines an Authorised Representative as being “…any natural or legal person established within the (European) Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation…”.
In effect, an EU Authorised Representative acts as a Manufacturer’s legal representative within the EU in relation to compliance with European Product Safety Directives and Regulations.
An EU Authorised Representative can also be known as a ‘Responsible Person’. It is often abbreviated to EUAR, EU Rep or EC Rep.
In most circumstances there is no mandatory requirement to appoint an EU Authorised Representative. If a Manufacturer is legally established within the European Union, it will never need to appoint an Authorised Representative. In all other cases, whether it is necessary to appoint an Authorised Representative will depend on which EU regulations are applicable to a Manufacturer’s products.
For example, under the EU’s regulations for Medical Devices (Regulation (EU) 2017/745) and In Vitro Diagnostic Devices (Regulation (EU) 2017/746), if a Manufacturer is not legally established within the European Union, it must appoint an EU Authorised Representative before it can place any products on the market.
In another circumstance, if a product falls within the scope of the EU’s EcoDesign requirements (Directive 2009/125/EC) and need to be registered on the EPREL database, that can only be done by either the Manufacturer if it is established in the EU, or by an Authorised Representative. Therefore, for Manufacturers with no established legal presence within the EU who need to register products on EPREL, it become mandatory to appoint an Authorised Representative.
Under EU regulations, an Authorised Representative is one of five recognised and defined types of Economic Operator.
The EU Market Surveillance Regulation 2019/1020 defines an Economic Operator as being ‘the Manufacturer, the Authorised Representative, the Importer, the Distributor, the Fulfilment Service Provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant (European) Union harmonisation legislation.
The precise scope of an EU Authorised Representative’s responsibilities will depend on the agreement between them and a manufacturer. However, as a minimum the EU authorities expect an Authorised Representative to do the following:
- Keep the EU Declaration of Conformity and the Technical Documentation at the disposal of national surveillance authorities and cooperate with them at their request,
- Upon a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product,
- Cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.
Other tasks may include:
- a Manufacturer and/or its products on an EU Database such as EPREL.
- Affixing the CE marking (and where relevant other markings) and, if required, a notified body’s number to a product,
- Drawing up and signing EU Declarations of Conformity.
Most EU Directives and Regulations regarding specific product types or technical requirements (e.g. Machinery, Pressure Equipment, Toys) will require that the name and physical address of the Authorised Representative is included on the Declaration of Conformity for a product.
Some EU Directives & Regulations will also include a requirement that the Authorised Representative is identified on a label or plate on the product itself.
If an Authorised Representative is acting as the Economic Operator for a product, the EU Market Surveillance Regulations will require the Authorised Representative’s details, including their name and address, to be clearly shown on either the product itself, on product packaging or on documentation accompanying the product. The information must be displayed when the product enters the EU Single Market.
Yes, as a minimum an Authorised Representative should be clearly identified on Declarations of Conformity issued for a Product and, when required by specific Directives or Regulations, on labelling affixed to the Product itself.
Yes, there must be a written agreement or ‘mandate’ between an Authorised Representative and their Client for the appointment to be considered valid. However, the precise wording of the agreement and the scope of the appointment can vary.
With BREXIT and the United Kingdom’s departure from European Union, the EU Directives and Regulations that required or allowed the appointment of Authorised Representatives no longer apply in the UK.
However, the UK Government has chosen to convert many of the existing EU Directives & Regulations into UK law, and in doing so have retained many of the concepts and requirements that go with them, including the concept of Authorised Representatives.
A UK Authorised Representative therefore fulfils the same function as an EU Representative, but for manufacturers placing their products on the UK market and in relation to the applicable UK statutory Regulations.
Yes, in both cases a Company can be an Authorised Representative. Under EU regulations a legal ‘Person’ can be an ‘association of persons’ such as registered company or another organisation. The same is the case for the UK.
For a Company to be an Authorised Representative it must be ‘established’ within the EU or UK, which in both cases means having one of the following:
- A registered office
- Central headquarters
- A permanent business establishment
Eurolink has established separate registered companies located in the UK and the Republic of Ireland respectively, allowing it to fulfil the requirements for being established in both the EU and UK and offer Authorised Representative Services in both territories.
Yes, an Authorised Representative can fulfil other functions, whether on behalf of the manufacturer or separately. For example, a Manufacturer could choose to appoint a local Distributor in the EU or UK to act as its Authorised Representative.
No, any party who holds the legal right to and responsibility for a product may appoint an Authorised Representative. For example, a Company that develops, markets and sells a product in its own name but outsources the product’s physical construction to a third-party may appoint an Authorised Representative to act on their behalf.
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