[1] Regulation of goods manufactured outside the European Union, particularly in the context of consumer product safety, led to the establishment of requirements for EU Authorized Representatives.
This representative acts as a contact point for competent authorities in EU member states and ensures that the product complies with applicable safety and traceability requirements.
is the entity to which the authorities and institutions of the EU Member States may address the obligations set out in the legal requirements for medical devices.
[7] European ‘Blue Guide"[8] describes that delegation of an authorised representative should be set out in writing (as an agreement, mandate, or power of attorney) to define contents and limits of tasks.
observes the manufacturers' compliance with the conformity assessment procedure set out in the European directives which apply to the product.
They ensure the law is met by having Class I medical devices registered with the Competent Authorities before being placed on the market.