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
...
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:
4) I’m a bit confused on interpreting deviations 5 & 6 in Annex ZA in 14971:2012 (and I know I’m not the only one...I read the posts
). They seem to indicate that BOTH “inherently safe design” AND “protection measures” are to be applied, ...taking into account the generally acknowledged state of the art..., and it actually says that the MDD (93/42) says that these are to be applied “cumulatively”. I don’t see in the MDD any reference that they must be applied cumulatively, because it actually says “In selecting the most appropriate solutions...”. I interpret the MDR as saying that we can still choose between either the first or second bullet (inherent design/protective measure), but 14971 seems to say that both must be applied. Am I interpreting Annex ZA correctly or not?
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
...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:
4) I’m a bit confused on interpreting deviations 5 & 6 in Annex ZA in 14971:2012 (and I know I’m not the only one...I read the posts
). They seem to indicate that BOTH “inherently safe design” AND “protection measures” are to be applied, ...taking into account the generally acknowledged state of the art..., and it actually says that the MDD (93/42) says that these are to be applied “cumulatively”. I don’t see in the MDD any reference that they must be applied cumulatively, because it actually says “In selecting the most appropriate solutions...”. I interpret the MDR as saying that we can still choose between either the first or second bullet (inherent design/protective measure), but 14971 seems to say that both must be applied. Am I interpreting Annex ZA correctly or not?
