Authorised Representative

The European Union defines an Authorised Representative as being ‘any natural or legal person established within the 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 essence that means any individual or organisation formally appointed by a Manufacturer to act on its behalf and in any capacity in regards to compliance with EU product Directives or Regulations

CE Mark/Marking

The CE Mark is a key indicator (but not proof) of a product's compliance with EU legislation and enables the free movement of products within the European Economic Area (EEA) and the Turkish market, whether they are manufactured in the EEA, Turkey or in another country.

"CE" is sometimes indicated as an abbreviation of "Conformité Européenne" (French for "European Conformity") but is not defined as such in the relevant EU legislation.

Declaration of Conformity

Under both EU and UK legislation, a Manufacturer or its Authorised Representative is required to draw up and sign a Declaration of Conformity before placing a product on the market.  The Declaration of Conformity, or DoC, is the document that states that that the product satisfies all the relevant requirements of the applicable compliance legislation. 

A DoC to EU legislation is known as an EU Declaration of Conformity.  A DoC to UK legislation is known as a UK Declaration of Conformity.  Failure to issue an accurate EU or UK DoC would invalidate the CE or UKCA Marks affixed to the relevant products, along with any associated compliance marking.

Distributor

The EU defines a Distributor as any individual or organisation in the supply chain, other than the manufacturer or the importer, who makes a product available on the EU market.  Note that a Distributor does not have to be established within the EU.  A similar definition applies in the UK for goods placed on the UK market.

Economic Operator

Under both EU and UK product compliance regulations, an Economic Operator is defined as being any of the following:

• A Manufacturer established in either the EU (for European regulations) or UK (for UK regulations)

• An Importer, where the Manufacturer is not established in the EU or UK

• An Authorised Representative

• A Distributor

• A Fulfilment Service Provider

European Directive

A European "Directive" is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals.

European Regulation

A European "Regulation" is a binding legislative act. It must be applied in its entirety across the EU by all member states.

Fulfilment Service Provider

The EU defines a Fulfilment Service Provider as being any individual or organisation offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, but without having ownership of the products involved.  Note that a Fulfilment Service Provider does not have to be established within the European Union.  Postal and courier services are excluded from the EU’s definition.

Importer

The EU defines an Importer as being any individual or organisation, established within the European Union, that places a product from outside the Union on the market in Europe.  A similar definition applies in the UK for products placed on the UK market.

In absence of an Authorised Representative being appointed by a Manufacturer, many of the responsibilities for ensuring and demonstrating regulatory compliance default to the Importer.  For example, the Importer can be held responsible for:

• Ensuring that the appropriate conformity assessment procedure has been carried out by the manufacturer

• Keeping a copy of the EU declaration of conformity for 10 years after the product has been placed on the market.

An Importer can also act as an Authorised Representative if a suitable, formal agreement to do so is reached with the Manufacturer.

Harmonised or Designated Standard

A product standard that is recognised and accepted across all member states of the EU and can therefore be used to demonstrate conformity to the requirements of an EU Directive or Regulation is known as a Harmonised Standard.  The equivalent for the UK and UK Regulations is known as a Designated Standard.

Manufacturer

In both the EU and the UK, a Manufacturer can be an individual or an organisation that actually designs, manufactures and sells a product itself, or it can also be an individual or organisation that has a product designed and/or manufactured on its behalf by 3rd parties but sells it under its own name or trademark.  Therefore, you do not have to be the actual physical manufacturer of a product to be considered the legal ‘Manufacturer’ for EU or UK regulatory compliance purposes.

Notified Body

A Notified Body is a conformity assessment body (CAB) which has been officially designated by the authorities in an EU Member State to carry out the procedures for conformity assessment specified by an EU Directive or Regulation.

The term ‘Notified Body’ comes from the fact that Member States must inform, or ‘Notify’, the European Commission of the decision to designate a specific CAB to carry out conformity assessment procedures.

Notified Bodies are often known as NBs or NoBo’s for short.

If a Manufacturer uses a Notified Body, they must be identified on the Declaration of Conformity for the relevant product.

Statutory Instrument

Statutory Instruments, also known as SI’s, are a form of UK legislation which allow the provisions of an Act of Parliament to be subsequently brought into force or altered without Parliament having to pass a new Act. They are also referred to as secondary, delegated or subordinate legislation.  UK product compliance Regulations are enacted into UK law using SI’s; for example the UK Electrical Equipment (Safety) Regulations 2016 contained within Statutory Instrument 2016 No. 1101

Technical Documentation

Also sometimes known as a Technical File or a Technical Construction File, under both EU and UK legislation Technical Documentation is name given to the compiled evidence of compliance with applicable product safety and/or performance regulations.  Typically, Technical Documentation will include test and assessment reports, evidence of ongoing quality management and product design information, amongst other relevant documents.  Detailed & specific requirements can be found in individual Directives and Regulations.

UK Approved Body

The equivalent to Notified Bodies in the UK and in regard to UK product compliance Regulations.  UK Approved Bodies (UKABs) are appointed by the UK Government.

UKCA Mark/Marking

The UKCA Mark replaced the CE Mark in the United Kingdom from January 1st, 2021 onwards.  It is a key indicator (but not proof) of a product's compliance with UK Regulations and enables the sale products within England, Scotland and Wales.  Different Marking requirements are applicable in Northern Ireland.

UKCA is an abbreviation of “United Kingdom Conformity Assessment”.

UK Regulation

Equivalent to a European Directive or Regulation under UK law.