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    EC Issues Additional Guidance on Device Vigilance System

    While highlighting an updated version of the manufacturer incident report (MIR) form that will become mandatory in January 2020, the European Commission (EC) issued guidance Tuesday on the medical device vigilance system under the EU’s medical device directive.   The January version of the MIR introduces the use of the adverse event terminology/coding harmonized via the International Medical Device Regulators Forum (IMDRF) and the use of unique device identification (U...