post-market surveillance

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:

   ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;

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:

   ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;

Used in (60 places in 26 provisions on 12/11/2026)

Medical Device Regulation (MDR) (60 in 26)

Recital 20 · Recital 32 · Recital 34 · Recital 74³ · Article 2² · Article 8 · Article 10² · Article 15 · Article 33 · Article 44 · Article 45 · Article 61² · Article 83⁵ · Article 84³ · Article 85³ · Article 86² · Article 88 · Article 91 · Article 120 · Annex ES · Annex I · Annex III⁷ · Annex IX⁶ · Annex VII⁹ · Annex XI² · Annex XIV