DoC (Declaration of Conformance) update required for Class II Medical Device?

marmotte

Involved In Discussions
#1
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I don't feel too confident to issue today a DoC referring to standards that are explicitly out of date; Of course I don't want to issue one referring to the new standards either as I haven't tested my products for them (10993) nor re-issued my risk management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.
 
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Stijloor

Staff member
Super Moderator
#2
Re: DoC (Declaration of Conformance) update required for Calss II Medical Device?

A Quick Bump!

Can someone help?

Thank you very much!!
 

pkost

Trusted Information Resource
#3
Has your technical file been subject to notified body review in the intervening period and since the standards have been updated?

As a manufacturer you have an obligation to maintain your technical file and product in light of post market surveillance to ensure that it remains safe and effective. Updates to standards sugggest a change to the state of the art, with an an improved understanding of aspects to improve safety and effectivity. By not keeping up with standards and without justification you are not maintaing your product...Your notified body should be flagging it

That being said, there is no requirement for you to comply with harmonised standards, just presumed conformity when it comes to review, therefore there is no reason why you cannot rely on old standards, just expect to be challenged by your notified body when they come to review it.....your product will have been on the market for a period of time and you should have been receiving product feedback/complaints, therefore it should be reasonably easy to demonstrate that your product is safe and effective despite not complying with the new standards

In summary, do you feel you have sufficient confidence and documented evidence to sign a declaration that your products meet the essential requirements of the directive? If the answer is yes, sign the DoC


It goes without saying that you should not declare compliance with the new standards when you do not comply!


Of course, this is all answered from a regulatory standpoint; from a commercial standpoint if I was a customer receiving a DoC with out of date standards, I may have cause for concern
 
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