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Declaration of Conformity for a Class III Medical Device Implant

D

danush

#1
Hello all!

My company developed a class III implant and we are now in the process of conformity assessment. One of the reviewers of the technical file raise the follwoing issue related to DoC:
According to the general interpretation by authorities, the declaration of conformity has to be limited to a series of specific devices (SN / LOT) manufactured or limited validity (expiry date) of the declaration should be indicated.

It seems that he requires us to specify all LOTs that we plan to manufacture or limit the DoC itself in time, which is not in line with MDD requiremenst, as far as I understand.

Can anyone clarify?
Thanks.
 
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rob73

looking for answers
#2
I am a bit sketchy on higher class products but I think it depends on which annex your classification route took you down. In annex III I think (could be wrong) your NB would asses each batch for conformity, therefore a batch number on the DoC would be appropriate.
Our product are Class 1, we do not identify by batch, we only state when the product was first placed on the market.
Rob
 
#3
There are several routes available to allow the Declaration of Conformity. These are described in Annexes II to VI of the directive.

Limiting a DoC to specific lots is appropriate if you are using annex VI -product quality assurance (probably in conjunction with annex III - EC type examination).

If you have an Annex II (Full quality assurance system) then there should be no need for the DoC to be limited to specific lots. But, of course, Annex II for a class III product is difficult to achieve.
 
Last edited:
D

danush

#4
We do apply for Annex II for which the directive says ' This declaration must cover one or more medical devices, clearly identified by means of product name, product code or other unambiguous reference' so we provided a list of catalogue numbers for our product line.

 

c.mitch

Quite Involved in Discussions
#5
Hello all!

My company developed a class III implant and we are now in the process of conformity assessment. One of the reviewers of the technical file raise the follwoing issue related to DoC:
According to the general interpretation by authorities, the declaration of conformity has to be limited to a series of specific devices (SN / LOT) manufactured or limited validity (expiry date) of the declaration should be indicated.

It seems that he requires us to specify all LOTs that we plan to manufacture or limit the DoC itself in time, which is not in line with MDD requiremenst, as far as I understand.

Can anyone clarify?
Thanks.
Hello danush,

If you apply article 11.1.a and annex II of the EC directive, the most common case for class III devices, then the declaration of conformity shall contain:
-the list of products, clearly identified as indicated in annex II.2
-an expiration date of the conformity.
The conformity can be valid a maximum of 5 years, see article 11, paragraph 11. It is the decision of the notified body to fix the duration of validity.

Maybe the reviewer was talking about this expiration date.

Regards,

Mitch.
 
D

danush

#6
c.mitch,

i think you're right. i haven't considered the fact that CE need to be re-newed and it can be a validity limiting factor for DoC.

thanks!
 
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