WE ARE ELIGIBLE TO BE APPOINTED AS YOUR AUTHORISED REPRESENTATIVE FOR YOUR PRODUCTS, TRUST US AND OUR EXPERIENCE IN ALLOWING YOUR PRODUCT SAFE AND PROFITABLE MARKET


WHO NEED AN AUTHORISED REPRESENTATIVE

Manufacturer established outside EU. In some cases also Manufacturer based in EU may appoint an Authorised Representative, but in this case there is no real advantage in having one.

WHAT AN AUTHORISED REPRESENTATIVE IS

According to the DECISION No 768/2008/EC of the European parliament and of the council of 9 July 2008 , the ‘authorised 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 AUTHORISED REPRESENTATIVE IS NOT

With respect to your product, the Authorised Representative is not a commercial role, but a compliance one. 

WHAT AN AUTHORISED REPRESENTATIVE DOES

The Decision 768(2008 states that at least the Authorised 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 AUTHORISED REPRESENTATIVE?

While for Medical Devices having an Authorised Representative is compulsory, for other directives (machinery, toys, RoHS, and others) is not compulsory but highly recommended. In the latter case, without an Authorised Representative most responsibilities will fall upon your importer (usually not aware of that), with damage to your distribution and high probability of mishandling.


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