harmonised standard

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:

   ‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;

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:

   ‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;

Used in (36 places in 18 provisions on 11/11/2026)

Medical Device Regulation (MDR) (36 in 18)

Recital 22 · Recital 23 · Recital 38 · Article 1 · Article 2 · Article 8⁴ · Article 9² · Article 10 · Article 17² · Article 32 · Article 71⁴ · Annex I² · Annex II² · Annex IX⁴ · Annex VII⁶ · Annex X · Annex XII · Annex XIV