CE marking of conformity

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 Also: CE marking

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

   ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;

2. 05/05/2017 – 25/05/2017 Article 2, Medical Device Regulation (MDR) Scope: Whole act Also: CE marking

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

   ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;

Used in (37 places in 12 provisions on 12/11/2026)

Medical Device Regulation (MDR) (37 in 12)

Recital 40 · Article 2⁵ · Article 10² · Article 20¹¹ · Article 21 · Article 22⁵ · Article 60 · Article 74² · Article 117 · Annex ES² · Annex V⁵ · Annex XIV