EU product legislation defines the following as economic operators:
- the manufacturer
- the importer
- the distributor
- the authorised representative
The manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured and places it on the market under his own name or trademark. The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements. The responsibilities of a manufacturer are the same whether he is established in a Member State or outside the EU. If an importer or distributor modifies a product they may be considered the manufacturer and must take on the responsibilities of the manufacturer.
The importer is the economic operator established in the EU who places a product from a third country on the EU market. Before placing a product on the market the importer must ensure:
- that the appropriate conformity assessment procedure has been carried out by the manufacturer
- that the manufacturer has drawn up the technical documentation
- affixed the relevant conformity marking (e.g. CE marking)
- fulfilled his traceability obligations
- accompanied, where relevant, the product with instructions and safety information in easily understandable language
If there is any doubt about the conformity of the product, the importer must not place it on the market or take corrective actions if the product has already been placed on the market.
As from the withdrawal date, a manufacturer or importer established in the United Kingdom will no longer be considered as an economic operator established in the EU.
The distributor is the economic operator in the supply chain, other than the manufacturer or the importer, who makes a product available on the market. A distributor acquires products for further distribution either from a manufacturer, an importer, or from another distributor.
Distributors are subject to specific obligations and have a key role to play in the context of market surveillance. They must not supply products that they know or should have assumed to be in compliance with the legislation. If they have reasonable grounds to believe that a product is not in conformity, they have to make sure that corrective measures are taken by the manufacturer or the importer and inform the competent national authorities and cooperate fully with the competent authority in any actions taken.
The Authorised Representative
Product manufacturers without a registered place of business in the EU exporting into the EU certain products such as medical devices, transportable pressure equipment, marine equipment and cosmetic products must designate an “authorised representative” or in the case of cosmetic products, a "Responsible Person". An authorised representative is appointed by a manufacturer to act on his behalf in carrying out certain tasks. Typically, a manufacturer might have more than one “authorised representative” if they have several products or devices on the market.
EU legislation requires the authorised representative or responsible person to be established in the EU. After Brexit, authorised representatives or responsible persons established in the UK will no longer be recognised. Manufacturers are advised to take the necessary steps to ensure that their designated authorised representatives or responsible persons are established in the EU-27.
Economic operators are advised to take the necessary steps to ensure that, where the applicable conformity assessment procedures require the intervention of a Notified Body, they will hold certificates issued by an EU-27 Notified Body to demonstrate compliance for their products placed on the market as from the withdrawal date.
Where economic operators hold certificates issued by a UK Notified Body prior to the withdrawal date and plan to continue placing the product concerned on the EU-27 market as from the withdrawal date, they are advised to either apply for a new certificate issued by an EU-27 Notified Body or arrange for a transfer – on the basis of a contractual arrangement between the manufacturer, the UK Notified Body and the EU-27 Notified Body - of the file and the corresponding certificate from the UK Notified Body to an EU-27 Notified Body, which would then take over the responsibility for that certificate. This responsibility depends on the specific conformity assessment procedure required for the product concerned under the applicable product legislation set out in the specific Directive’s Annex.
The appointment of an authorised representative does not change the responsibilities of the manufacturer under the relevant Directive. It is the responsibility of the manufacturer to designate and supervise the authorised representative and they must keep their authorised representative informed of all matters that may be connected to the products/devices placed on the market in the EU.
The EU Commission recommends that in order to clarify the specific roles of the authorised representative and the manufacturer, a written contract outlining the respective responsibility should be agreed between the manufacturer and their authorised representative.
The main purpose of an "authorised representative" is to act as a main point of contact between the EU Commission and the National Competent Authority.
The duties of an “authorised representative” are set out in a number of harmonised regulations and directives. EU product legislation does not generally oblige the manufacturer to designate an authorised representative. However, there is some specific EU legislation that sets out an obligation to have an authorised representative- medical devices, transportable pressure equipment or marine equipment or a responsible person- cosmetic products, established in the EU.
In additional to the obligations outlined in the relevant directive, there may be specific national legislative requirements that an authorised representative will have to adhere to. An authorised representative must therefore be fully informed about the legal obligations included in the national legislation of the Member State in which the products are placed on the market.
They often will have to carry out any post-market surveillance that is necessary.
Some of the main duties of an EU Authorised Representative include:
● Register the product or device with the National Competent Authorities before it is placed on the market
● Act as the main primary contact point for National Competent Authorities
● Maintain a current copy of the Technical File available for inspection by the European Competent Authorities
● Reports to National Competent Authorities and maintains reports for review
● Inform their company of any changes to the relevant laws
● If required, acts as a company’s representative in front the European Commission
● Some sectors such as medical devices, the EU Authorised Representative must supply contact details on the packaging and associated materials of the device
● Notifies or is notified by the Competent Authorities of serious device incidents
The ‘Blue Guide’ on the implementation of EU products rules 2016 provides more information and guidance on:
- the duties and responsibilities of economic operators
- product requirements
- conformity assessment
- market surveillance