Authorised representative

A manufacturer outside the EU cannot place devices on the EU market without one. The mandate defines the tasks, and the authorized representative shares legal responsibility for defective devices with the manufacturer, so the choice and the contract deserve care.

‘authorised representative’ means any natural or legal person established within the Union 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 this Regulation;

EU MDR, Article 2(32)

‘authorised representative’ means any natural or legal person established within the Union 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 this Regulation;

IVDR, Article 2(25)

natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation [SOURCE: GHTF/SG1/N055:2009, 5.2]

ISO 13485:2016, clause 3.2