risk

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:

   ‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;

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:

   ‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;

Used in (251 places in 65 provisions on 12/11/2026)

Medical Device Regulation (MDR) (251 in 65)

Recital 12² · Recital 15 · Recital 22 · Recital 31 · Recital 32³ · Recital 33³ · Recital 39 · Recital 51 · Recital 56 · Recital 58² · Recital 59 · Recital 74 · Recital 81² · Recital 83 · Article 1² · Article 2⁵ · Article 7 · Article 8 · Article 10⁶ · Article 10a · Article 11 · Article 13³ · Article 14³ · Article 17 · Article 20 · Article 27 · Article 32 · Article 45² · Article 46 · Article 51 · Article 52 · Article 54 · Article 61² · Article 62⁴ · Article 63 · Article 64 · Article 65 · Article 66 · Article 68 · Article 69 · Article 71⁴ · Article 83³ · Article 86 · Article 88² · Article 89⁶ · Article 90⁴ · Article 93³ · Article 94² · Article 95⁴ · Article 96 · Article 97 · Article 98 · Article 99 · Article 100 · Article 120² · Annex I⁸⁰ · Annex II⁵ · Annex III⁴ · Annex IV · Annex IX¹⁷ · Annex VI² · Annex VII¹⁶ · Annex XII² · Annex XIV¹³ · Annex XV⁹