conformity assessment body

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:

   ‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;

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:

   ‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;

Used in (22 places in 9 provisions on 11/11/2026)

Medical Device Regulation (MDR) (22 in 9)

Article 2² · Article 35⁴ · Article 38 · Article 39⁵ · Article 40 · Article 42⁵ · Article 105 · Article 120 · Annex VII²