Dear all,
My company manufactures some class IIa products. We have released them in Europe a few years back. (e.g. before the new EN14971:2012 and 10993:2009), with a DoC dated from then, referring to the previous versions of these harmonized standards.
There has been some hiccups in the communication with my EC Rep, who is now asking me to provide updated DoC for these products, and it is asking me to use as specific template which is slightly different from the one used back then.
I don't feel too confident to issue today a DoC referring to standards that are explicitly out of date; Of course I don't want to issue one referring to the new standards either as I haven't tested my products for them (10993) nor re-issued my risk management file (14971). I am planning to generate and document a proper gap-analyis for those of course but I'd like first to address my EC Rep requests.
What would you advise me to do? Just resend to my EC Rep the old DoC and insist that it is the most up to date one?
Thanks in advance.
My company manufactures some class IIa products. We have released them in Europe a few years back. (e.g. before the new EN14971:2012 and 10993:2009), with a DoC dated from then, referring to the previous versions of these harmonized standards.
There has been some hiccups in the communication with my EC Rep, who is now asking me to provide updated DoC for these products, and it is asking me to use as specific template which is slightly different from the one used back then.
I don't feel too confident to issue today a DoC referring to standards that are explicitly out of date; Of course I don't want to issue one referring to the new standards either as I haven't tested my products for them (10993) nor re-issued my risk management file (14971). I am planning to generate and document a proper gap-analyis for those of course but I'd like first to address my EC Rep requests.
What would you advise me to do? Just resend to my EC Rep the old DoC and insist that it is the most up to date one?
Thanks in advance.
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