Our NB says that IEC 62304 is an ISO 14971 Requirement

blah01

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#1
Hello all,
I have some questions regarding interpretation of the requirements related to EN ISO 14971:2012 (I use ‘ISO 14971’ interchangeably below) and ISO 62304:2006. Note that I am fairly new to the Cove; I posted 1 question last year and couldn't even figure out how to find it again on the site...a bit pathetic on my part I guess :bonk:...

I have spent nearly 2 days reading through the many posts on these standards to make sure I didn't simply throw out questions that were answered already, and found it to be very informative, although I still have a couple of questions left over which I would greatly appreciate some guidance on.

First as background information, we are a North American manufacturer and our product is a stand-alone software which is considered "aids for disabled/handicapped people", per definition "2.9 medical device" Note 2 in ISO 14971:2012, and which we have classified as a Class A device under ISO 62304. We are compliant to ISO 62304 and are now in the process of implementing EN ISO 14971:2012 since we will be selling in Europe. Note that I am also familiar with the Essential Requirements in MDD 93/42, of which the relevant requirements are addressed by Annex ZA in EN ISO 14971.

My questions are as follows:

2) We've been told by our NB that IEC 62304 is a requirement so we did it (note that this was a good ‘hand in glove’ fit for us so it was no big deal...we would have spent more time debating it than just doing it). However, it is unclear if ISO 14971 is a requirement. IEC 62304 section 4.2 says we need to have a risk management process complying with ISO 14971, however per definition "2.9 medical device" Note 2 in EN ISO 14971:2012, it indicates that there is no harmonized approach yet to devices such as ours, so it is unclear if ISO 14971 is indeed a requirement or not for "aids for disabled/handicapped people". Could anyone shed some light on this?

3) In parallel with question 2, is the approach we took in defining the safety classification of our device per 62304 correct, meaning that we only considered “when used under the conditions and for the purposes intended”, and not “misuse”? When defining our ‘intended use’ statement, we actually identified some exclusions to this, meaning we identified uses of the product which it is not intended for (for example, “does not include rock climbing” ...again, our device is a software product, so the prosthetic/rock climbing example is simply an analogy).
 
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