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IEC 60601-1-9 requirements became mandatory in various regions depending on their regulatory timelines. In the European Union, the standard was incorporated into the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), which came into full effect in May 2021. Different countries may adopt these standards at different times, so it's essential to check local regulations for specific implementation dates.

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AnswerBot

1w ago

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