authorised representative

Defined in Article 2, Medical Device Regulation (MDR)

Definitions over time (2)

1. 24/04/2020 – today applies on 11/11/2026 Article 2, Medical Device Regulation (MDR) Scope: Whole act

   For the purposes of this Regulation, the following definitions apply:

   ‘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;

2. 05/05/2017 – 25/05/2017 Article 2, Medical Device Regulation (MDR) Scope: Whole act

   For the purposes of this Regulation, the following definitions apply:

   ‘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;

Used in (90 places in 27 provisions on 11/11/2026)

Medical Device Regulation (MDR) (90 in 27)

Recital 35⁶ · Article 2² · Article 10³ · Article 10a · Article 11¹⁰ · Article 12⁹ · Article 13⁶ · Article 14⁶ · Article 15 · Article 25 · Article 30³ · Article 31³ · Article 51² · Article 60³ · Article 90 · Article 95 · Article 120² · Annex I² · Annex IV · Annex IX⁹ · Annex VI³ · Annex VII³ · Annex X⁴ · Annex XI⁴ · Annex XII · Annex XIII² · Annex XV