incident

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:

   ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;

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:

   ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;

Used in (89 places in 29 provisions on 12/11/2026)

Medical Device Regulation (MDR) (89 in 29)

Recital 32² · Recital 41 · Recital 46² · Recital 75 · Recital 76⁵ · Recital 77² · Recital 78 · Recital 79 · Recital 81 · Recital 98 · Article 2⁴ · Article 10² · Article 11 · Article 12 · Article 13 · Article 14 · Article 17 · Article 27 · Article 83 · Article 87²¹ · Article 88⁵ · Article 89¹³ · Article 91⁴ · Article 92⁴ · Article 123 · Annex I · Annex III⁸ · Annex IX · Annex XIII