Economic Operators

We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.

Economic Operators (EO) include manufacturers, Authorized Representatives (EC REPs), importers, and distributors.
BioReg advises on all issues related to Quality Agreements between EOs. The legal definition of individual and mutual responsibilities is of the utmost importance for the company’s success.

A manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.

Authorized representative means any natural or legal person established within the Union (EU) who has received and accepted a written mandate from a manufacturer located outside the Union to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under MDR or IVDR (see MDCG 2022-16 – Guidance on Authorised Representatives Regulation).

Importer means any natural or legal person established within the Union that places a device from a third country on the Union market.

Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.


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