derivative

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:

   ‘derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues;

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:

   ‘derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues;

Used in (48 places in 13 provisions on 12/11/2026)

Medical Device Regulation (MDR) (48 in 13)

Recital 11 · Article 1⁶ · Article 2 · Article 89 · Annex I¹⁰ · Annex II² · Annex IX¹³ · Annex VI² · Annex VII · Annex VIII² · Annex XI² · Annex XIII · Annex XV⁶