FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

European Commission Clears Up Devicemaker Vigilance Obligations

July 23, 2019
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The European Commission has issued new guidance that explains device manufacturer obligations under its Medical Device Vigilance System.

The system, which was established by the Medical Devices Directive (MDD) is designed to improve safety “by reducing the likelihood of reoccurrence of incidents” related to device use, the commission said.

The guidance includes an updated manufacturer incident report (MIR) form that will be required for devices certified under MDD in January 2020. It also draws distinctions between field safety corrective actions (FSCAs) and field safety notices (FSNs).

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