Authorized representative in Europe.
The authorized representative is a NECESSARY figure for manufacturers not established in the Union. The authorized representative plays a fundamental role in ensuring the compliance of the products they manufacture and serves as a contact person established in the Union.When 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 authorized representative.deviCE Sistemas can act as an Authorized Representative, acting on behalf of the Product manufacturer, as it has the necessary knowledge and experience to ensure compliance with the legal requirements of the product to be marketed in the EU.
deviCE Sistemas prepares the individualized and personalized mandates necessary for each producer with the activities to be carried out as an Authorized Representative according to the legislation to be complied with, ensuring that nothing is left to chance.Registered as a responsible entity in AEMPS, as it is one of the fundamental economic agents in the life cycle of Medical Devices.Similarly, in the case of Medical Devices, the Authorized Representative must register with EUDAMED with the mandates received from product manufacturers.