conformity assessment

Defined in Article 2, Medical Device Regulation (MDR)

Definitions over time (2)

1. 24/04/2020 – today applies on 10/11/2026 Article 2, Medical Device Regulation (MDR) Scope: Whole act

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

   ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;

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’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;

Used in (210 places in 57 provisions on 10/11/2026)

Medical Device Regulation (MDR) (210 in 57)

Recital 4 · Recital 5 · Recital 12 · Recital 15 · Recital 20 · Recital 44 · Recital 55 · Recital 56 · Recital 58 · Recital 60 · Recital 61 · Recital 93 · Article 2⁴ · Article 7 · Article 10² · Article 11² · Article 20 · Article 22 · Article 29 · Article 31² · Article 32 · Article 35⁵ · Article 37⁴ · Article 38² · Article 39⁷ · Article 40 · Article 42⁷ · Article 43 · Article 44² · Article 46 · Article 50 · Article 52¹³ · Article 53⁸ · Article 54 · Article 55 · Article 56 · Article 57 · Article 58² · Article 61 · Article 62 · Article 73 · Article 86² · Article 99 · Article 105 · Article 106 · Article 117² · Article 120¹¹ · Article 123² · Annex ES³ · Annex I² · Annex IV · Annex IX⁹ · Annex VII⁷⁶ · Annex X² · Annex XI⁴ · Annex XII⁴ · Annex XIV