Role of Authorised Representative

A common definition of an “Authorised Representative” is “any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation”.

Product manufacturers without a registered place of business in EU exporting into the EU certain products such as medical devices must designate an “Authorised Representative”.  Typically, a manufacturer might have more than one “Authorised Representative” if they have several products or devices.

Some of the main duties of an EU Authorised Representative include:

Main duties of an EU Authorised Representative 

● Register product or device with the National Competent Authorities before they are 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

 

● 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.

Duties and responsibilities of an EU 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.  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.

Role of Manufacturer and Authorised Representatives

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 designated 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.  

Role of Economic Operators

Union product legislation defines as economic operators the manufacturer, the importer, the distributor and the authorised representative. 

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 consider either applying for a new certificate issued by an EU-27 Notified Body or arranging 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.