Authorised Representative in Europe
The authorised representative is a NECESSARY figure for manufacturers who are not established in the European Union. The authorised representative plays a fundamental role in guaranteeing the conformity of the products they manufacture and serves as a contact person established in the Union.
Where the manufacturer of a product is not established in a Member State of the Union, the product can only be placed on the market if the manufacturer appoints an authorised representative.
deviCE Sistemas can act as an Authorised Representative, acting on behalf of the manufacturer of the product, since it has the necessary knowledge and experience to ensure compliance with the legal requirements of the product to be placed on the EU market.
deviCE Sistemas prepares the individualised and personalised mandates necessary for each producer with the activities to be carried out as an Authorised Representative depending on the legislation to be complied with, so that nothing is left to chance.
Registered as a responsible figure in AEMPS, as it is one of the fundamental economic agents in the life cycle of the Medical Device.
Likewise, in the case of a Medical Device, the Authorised Representative must register with EUDAMED with the mandates received from the product manufacturers.
Would you like to know about it?