manufacturer

Defined in Article 2, Medical Device Regulation (MDR)

Definitions over time (2)

1. 24/04/2020 – today applies on 12/11/2026 Article 2, Medical Device Regulation (MDR) Scope: Whole act

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

   ‘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 trade mark;

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:

   ‘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 trade mark;

Used in (595 places in 93 provisions on 12/11/2026)

Medical Device Regulation (MDR) (595 in 93)

Recital 12² · Recital 15² · Recital 19 · Recital 22 · Recital 29 · Recital 31 · Recital 32² · Recital 34 · Recital 35⁵ · Recital 36 · Recital 38³ · Recital 45 · Recital 46 · Recital 48 · Recital 51 · Recital 52² · Recital 57² · Recital 60 · Recital 63 · Recital 74² · Recital 76² · Recital 78 · Recital 83 · Recital 92 · Recital 98² · Article 2²⁵ · Article 9² · Article 10²⁶ · Article 10a⁴ · Article 11¹⁴ · Article 12³ · Article 13¹² · Article 14¹³ · Article 15³ · Article 16⁹ · Article 17⁴ · Article 18³ · Article 19³ · Article 21 · Article 22⁶ · Article 25 · Article 26 · Article 27⁴ · Article 28 · Article 29⁴ · Article 30³ · Article 31⁴ · Article 32³ · Article 33 · Article 36 · Article 44² · Article 45³ · Article 46⁷ · Article 51⁵ · Article 52¹³ · Article 53⁵ · Article 54³ · Article 56⁴ · Article 58³ · Article 60³ · Article 61¹⁷ · Article 62² · Article 71 · Article 83⁴ · Article 85 · Article 86⁵ · Article 87¹⁶ · Article 88³ · Article 89¹⁶ · Article 90 · Article 91² · Article 92⁶ · Article 95 · Article 105 · Article 106⁵ · Article 117² · Article 120⁹ · Article 122² · Article 123⁴ · Annex I³⁷ · Annex II⁶ · Annex III⁴ · Annex IV² · Annex IX⁵² · Annex VI¹⁹ · Annex VII⁷⁶ · Annex VIII² · Annex X¹³ · Annex XI²³ · Annex XII⁵ · Annex XIII⁵ · Annex XIV¹⁰ · Annex XV⁵