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According to the EU laws, a manufacturer that is not established within the European Union must appoint a representative, a person other than the importer or the distributor, who will represent the manufacturer in the whole European Union (whereas may have many distributors and/or sales agents in the EU).
The duties of the EU Authorised Representative are firstly those of being a point of contact for the European and national authorities responsible for market surveillance and product safety, that may contact at any time the Authorized Representative for information about the products.
Manufacturers are obliged in ensuring that their products, placed on the extended Single Market of the EEA (27 European Union Member States + Iceland, Liechtenstein and Norway) meet European safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the European market.
A non-EU manufacturer, to affix the CE marking on the product have to identify, firstly, the applicable directive and harmonised standards, verify the product specific requirements and identify if an independent conformity assessment is necessary; after having tested the product and checked its conformity, draw up and keep available the required technical documentation together with the EU Declaration of Conformity.
The EU regulations set a list of products for which, due to the higher safety risks, safety cannot be checked by the manufacturer alone and must be performed by an independent organisation, a notified body appointed by national authorities.
Under the EU decision N. 768/2008/EC on a common framework for the marketing of products, the Authorized Representative shall perform the tasks specified in the mandate received from the manufacturer. The “new approach” directives have an explicit obligation of the written form for the appointment of the Authorized Representative by the manufacturer.
The mandate shall allow the Authorized Representative to do at least the following tasks:
keep available for the national supervisory authority the EC declaration of conformity and the technical documentation for a period of ten years following the placing on the market of a product.
Reporting of incidents, authorities’ actions, products recall, corrective actions.
Notification to competent authorities of Products, their performance, characteristics and changes (registration, renewal, update)
Following a reasoned request from a competent national authority, provide all 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 the mandate.
Studio Arpaia provides a full service for the appointment of the EU Authorised Representative for the following product groups:
MEDICAL DEVICES (IVD, AIMDD) – LOW VOLTAGE APPLIANCES – PERSONAL PROTECTIVE EQUIPMENT – CONSTRUCTION PRODUCTS – GAS APPLIANCES – CABLEWAY INSTALLATIONS – MACHINERY – TOYS – SMALL AND MEDIUM BOATS – RADIO AND TELECOMMUNICATION EQUIPMENT – ATEX PROTECTIVE EQUIPMENT – EXPLOSIVES – BOILERS – LIFTS – MEASURING INSTRUMENTS – WEIGHING INSTRUMENTS – PRESSURE EQUIPMENT – PYROTECHNICS – ENERGY RELATED PRODUCTS
Conformity for: Electromagnetic compatibility – Noise emission in the environment – Restriction of Hazardous Substances in Electrical and Electronic Equipment