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WE ARE ELIGIBLE TO BE APPOINTED AS YOUR AUTHORIZED REPRESENTATIVE FOR YOUR PRODUCTS, TRUST US AND OUR EXPERIENCE IN ALLOWING YOUR PRODUCT SAFE AND PROFITABLE MARKET
WHO NEED AN AUTHORIZED REPRESENTATIVE
Manufacturer established outside EU. In some cases also Manufacturer based in EU may appoint an Authorized Representative, but in this case there is no real advantage in having one.
WHAT AN AUTHORIZED REPRESENTATIVE IS
According to the DECISION No 768/2008/EC of the European parliament and of the council of 9 July 2008 , the ‘Authorized Representative’ shall mean 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.
WHAT AN AUTHORIZED REPRESENTATIVE IS NOT
With respect to your product, the Authorized Representative is not a commercial role, but a compliance one.
WHAT AN AUTHORIZED REPRESENTATIVE DOES
The Decision 768(2008 states that at least the Authorized Representative shall keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a certain period (usually from 5 to 10 years). Further, to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product. He also must cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.
For medical Devices, the responsibilities are even wider, having a role in the registration of the devices to the competent Ministry of Health, vigilance system and incidents handling.
IS IT COMPULSORY HAVING AN AUTHORIZED REPRESENTATIVE?
While for Medical Devices having an Authorized Representative is compulsory, for other directives (machinery, toys, RoHS, and others) is not compulsory but highly recommended. In the latter case, without an Authorized Representative most responsibilities will fall upon your importer (usually not aware of that), with damage to your distribution and high probability of mishandling.