Safety & EMC certificate updated when MCU (MIcro-Controller) is changed?



We have the 3rd version of Safety 60601-1 & EMC 60601-1-2 certificate

As our current-used MCU will be faded out, we need to change to other MCU (micro-controller) with same function.
For this change, it will cause
  • PCB layout change only &
  • Accordingly, some component in PCBA was changed
(Note: The main point is no change in Intended for use, performance, output, outercase)

Certificate need to re-apply ?
For this case, do we need to update the Safety & EMC certificate?
In case if not update, what documentation is required?
For our planned action is to prepare some documentation by comparing the difference between OLD MCU & NEW MCU, & providing the related internal test & external test (For external test, we concern for EMC, we will have test from 3rd party), is it enough?

FDA 510(k) need to re-apply ?
I have checked the “Deciding When to Submit a 510(k) for a Change to an Existing Device”, for our case, for class 2 medical device products, it seems that the above change are required to “documentation” only, is it correct ?


With respect to your 510(k): as this is about replacing an obsolete component, this is almost certainly a change that does not require submission of a new 510(k). Please note that it is still the same amount of work (documentation) but no need to submit to FDA.

With respect to IEC60601: you have to demonstrate why your 60601-1 and 60601-1-2 testreports (and derived certificates) are still valid after applying the change. Small layout changes can have impact on EMC compliance just as introducing a new processor running on different clock frequencies. I have even seen an example where a 'small layout change' reduced creepage on a board from 10mm to 2mm where 8mm was required leading to a large recall.

As whether or not to retest depends on many other factors (architecture, critical parts changed, were you close to the limits in the current design, etc). Many testlabs are willing to discuss with you if retesting is required although you (legal manufacturer) will always be finally responsible.
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