>> Due to the high demand for the COVID-19 emergency, do you want to export your medical devices and PPE in Italy and/or European Union?

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 and safe business. 




Services for export in the EU



WE offer, since 1994, an advanced and complete range of services for the foreign companies that want to export products and services in the European market.

WE help and supports  the customers to manage all the obligations the European law and regulations provide for marking of conformity, appointment of Authorised Representative, meet the European and international standards and fulfill the requests of national and European authorities.

 We also assists  the customers for custom compliance, risks analysis/assessment/management, technical support, translation, accreditation and representation before the European bodies, classification, labelling and packaging.


INTRODUCTION on the figure of the EU A.R.


According to the EU laws, a manufacturer that is not established within the European Union must be 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 (28 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:

a) 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 the toy;

b) following a reasoned request from a competent national authority, provide all information and documentation necessary to demonstrate the conformity of a toy;

c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by toys covered by their mandate. ".

For "authorized representative" means, therefore, the natural or legal person established in the 'European Union, specifically designated - a written instrument - the' manufacturer 'for the purpose of affixing the "CE" marking and the purpose of further activities to be specified in the "mandate" contract.

The figure of the "agent" is usually - but not necessarily - expected in cases where the "manufacturer" is located in a country other than the EU Community. The figure of the "authorized representative" can in no way be confused with other figures belonging to the trade chain, such as "importers" and "distributors".



 We provides a full service for the appointment of the EU Authorised Representative for the  






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CE marking - Obtaining the Certificate




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