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.

Any Manufacturer or other party responsible for the regulatory compliance of products placed on the market in EU and/or the UK, but who is located outside of those territories, should consider appointing an Authorised Representative to act on their behalf.

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 EU 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.

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.

No. Both the UK and EU separately require a person acting as an Authorised Representative to have their primary home in either the UK or an EU Member State, respectively. As one person cannot have two primary homes in two different locations, it is not possible for a single individual to be an Authorised Representative for both the UK & EU.

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 ‘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 he requirements for being established in both the EU and UK and offer Authorised Representative Services in both territories.

No, not in all circumstances. Some EU Directives or Regulations, such as the Medical Device Regulation 2017/745 (MDR), do make it mandatory for manufacturers who are located outside of the European Union and whose products fall within their scope to appoint an Authorised Representative. In contrast, other Directives and Regulations make the appointment of an Authorised Representative entirely optional.

No, as with the EU, it is not necessary to appoint an Authorised Representative unless the specific UK Regulation that are applicable to your product require it.

If the Directives or Regulations applicable to your product include a mandatory requirement to appoint an Authorised Representative, then failing to do so might invalidate any claim of compliance that you make.

Where appointment of an Authorised Representative is voluntary, and the Manufacturer is based outside of the EU or the UK, legal responsibility for regulatory compliance will often default to another party involved in the importation, sale, distribution or use of a Product within either territory. For example, responsibility and liability may automatically pass to the importer of a Product if they are located within the EU or the UK, even if they had no involvement in its design or manufacture.

There are many potential benefits to voluntarily appointing an Authorised Representative in both the EU and the UK. A few examples include:

• Providing reassurance – Putting the name of an Authorised Representative on a Declaration of Conformity can reassure customers, importer and distributors that a Manufacturer has taken steps to ensure their product is compliant and safe to use, that liability has been formally assigned and that there is a local contact point should any issues arise.
• Maintaining consistent responsibility – For manufacturers supplying the same product to multiple customers across the EU & UK, appointing an Authorised Representative ensures that one single party has legal responsibility for all units shipped. The alternative could be responsibility for individual units defaulting to customers or other parties.
• Local knowledge and expertise – Because they’re based within the UK or the EU, Authorised Representatives can provide local knowledge of regulatory requirements, and if necessary provide a point of contact with local authorities.

The precise benefits a Manufacturer can gain from appointing an Authorised Representative will depend on individual circumstances.

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.

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.

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, 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.

Some Directives and Regulations may include a requirement that the Authorised Representative has sufficient to relevant technical knowledge or experience to fulfil the role. However, in the majority of cases there are no requirements for an Authorised Representative to maintain relevant technical qualifications.