EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.92_93_94_95: Market surveillance and Member-State competent authorities (Articles 92-95)

Article 92 establishes market-surveillance powers of competent authorities including unannounced inspections of premises + sampling + testing. Article 93 covers evaluation of devices presenting a risk + measures available (corrective action, withdrawal, recall). Article 94 covers cases where devices comply with the Regulation but still present a risk. Article 95 covers cases of formal non-compliance with the Regulation.

Other controls in IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)

IVDR-Art.102_103_104 Confidentiality, data protection and Medical Device Coordination Group cooperation (Articles 102-104)
IVDR-Art.110 Transitional provisions (Article 110 as amended by (EU) 2024/1860)
IVDR-Art.112_113 Penalties and entry into force (Articles 112-113)
IVDR-Art.78 Post-market surveillance plan and system (Article 78)
IVDR-Art.80_81 Periodic Safety Update Report (Article 80 + 81)
IVDR-Art.82_83_84_85_86 Vigilance + serious incident reporting + field safety corrective actions (Articles 82-86)

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MCP endpoint All EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls