custom-made device

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:

   ‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

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:

   ‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

Used in (29 places in 18 provisions on 12/11/2026)

Medical Device Regulation (MDR) (29 in 18)

Recital 42 · Article 2² · Article 10² · Article 10a · Article 15 · Article 21³ · Article 27 · Article 29³ · Article 30 · Article 31 · Article 52 · Article 61 · Article 84 · Article 86³ · Article 123² · Annex ES · Annex I² · Annex XIII²