The Euro­pean Com­mis­sion has updat­ed its Q&A doc­u­ment on UDI require­ments under the Med­ical Devices Reg­u­la­tion (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR). The paper pro­vides answers to basic ques­tions on the UDI sys­tem require­ments under the new Reg­u­la­tions and how those relate to the oblig­a­tions of eco­nom­ic operators.

Source: Euro­pean Commission

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