60601 GAP Assessments

Jvalerio

Registered
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.
 

mr9000

Involved In Discussions
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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