EU Medical Devices Regulation (MDR 2017/745)
MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)

EU Medical Devices Regulation (MDR 2017/745) MDR-Art.93_94_95_96_97_98: Market surveillance + Member-State competent authorities (Articles 93-98)

Article 93 establishes market-surveillance powers including unannounced inspections + sampling + testing. Article 94 covers evaluation of devices presenting a risk + measures available (corrective action, withdrawal, recall). Article 95 covers cases where devices comply with MDR but still present a risk. Article 96 covers cases of formal non-compliance with MDR. Articles 97-98 cover product-safety procedures + Union-level action.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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