60601 GAP Assessments


We have a medical device already on the market that was tested to 60601-1:2012, 60601-2-22:2012, 60601-1-2:2014. We're currently not making any changes to the device, but I'm wondering if we need to meet the amendments for IEC 60601-1-2:2014/AMD1:2020, IEC 60601-2-22:2020, IEC 60601-1 Amd.2 Ed. 3.0 b:2020. From what I've searched the FDA only requires testing to the new editions for new product, but not for existing devices on the market.


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You could get a redline version of the newest version and check for differences, set up a gap analysis and come to the conclusion that the tests your device has passed are still valid for the newest version and therefore you do not need new tests.
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