Is there an Expiry Date for "Declaration of Conformity" (DOC) for Medical Devices?

S

sasiv

#1
Is there an expiry date for "Decleration of Conformity" (DOC) for medical devices?
Is there a requirement for renewal of the DOC in any time (for example if re-certificate the ISO 13485)?
 
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S

sasiv

#2
Decleration of Conformity

Is there an expiry date for "Decleration of Conformity" (DOC) for medical devices?
Is there a requirement for renewal of the DOC in any time (for example if re-certificate the ISO 13485)?
 

harry

Super Moderator
#3
Re: Is there an expiry date for "Declaration of Conformity" (DOC) for medical devices

Welcome to the Cove.

There is no need for multiple posting because moderators will move your post(s) to the right forum. Some one will respond to your post soon. Meanwhile, have a look at the threads in the 'Similar Discussion Threads' area towards the bottom of this page (just scroll down).
 
S

SteveK

#4
Re: Decleration of Conformity

Is there an expiry date for "Decleration of Conformity" (DOC) for medical devices?
Is there a requirement for renewal of the DOC in any time (for example if re-certificate the ISO 13485)?
I am not aware of an expiry date for DoC. In our case our DoC lists our series of medical devices, so if I add a variant (which does not fall outside our CE Certificate product listing) I then add it to the listing and update and reissue the DoC.

However, in the directive it indicates:

Annex II

6.1. ►M5 The manufacturer or his authorised representative must, for a periodending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities: ◄

— the declaration of conformity,


So I guess after these dates I guess it can kind of 'expire', cease to exist, push off its mortal coil etc (sorry, slipped into Monty Python ‘dead parrot’ mode).

Steve
 
A

Alexisss

#5
Re: Is there an Expiry Date for "Declaration of Conformity" (DOC) for Medical Devices

The DoC is needed in order to place the product in the market, therefore is not "expiring", even if the product use-by or expiry date passes.

Depending on your document management policy, you can include a document version indication and a document revision date, but as part of your 13485 document handling process and will not mean that the DoC "expired".

You must have the document available (for audit/inspection by CAs etc) for 5/15 years after the last manufacture of the product, but this doesn't imply that the DoCs that you have already sent out cease to be valid after this period.
 
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