Glossary

Authorised representative [MDR/IVDR]

MDR IVDR

‘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.

 

[Definition under (EU) 2017/745 Article 2 No. 32 also corresponds to definition under (EU) 2017/746 Article 2 No. 25]