Requirements for Declaration of Conformity - Compliance to MDD

R

Roland Cooke

#11
Well it's from a Directive, though not the MDD. I'll try to identify it.

Content looks reasonable at first glance.
 
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P

Persson - 2010

#12
Well it's from a Directive, though not the MDD. I'll try to identify it.

Content looks reasonable at first glance.
Our consultants from Wellkang says "... this EC declaration of conformity is the latest model structure set out by the European Parliament and the Council which shall apply to all CE-marking related directives and it is the single declaration drawn up by the manufacturer in respect of all Community acts applicable to their products placed on the EEA market."

We were requested by Wellkang, our EC Representative to revise our EC Declaration of Conformity according to this model structure.
 
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R

Roland Cooke

#13
Yes that makes sense, I know there has been a lot of pressure to harmonise all this stuff. If Wellkang can identify the original document (it says Annex III, but unclear pertaining to what), that would be helpful.
 
P

Persson - 2010

#14
Yes that makes sense, I know there has been a lot of pressure to harmonise all this stuff. If Wellkang can identify the original document (it says Annex III, but unclear pertaining to what), that would be helpful.
I will ask our consultants in Wellkang and get back to you asap.
 
P

Persson - 2010

#15
Yes that makes sense, I know there has been a lot of pressure to harmonise all this stuff. If Wellkang can identify the original document (it says Annex III, but unclear pertaining to what), that would be helpful.
Attached is the original document we got from Wellkang.

DECISION No 768/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC.

Annex III is on the last page no. 47.
 

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kapinka

Starting to get Involved
#16
Hi guys,

I have a question.
We are certified according to EN ISO 13485, but we do not have a CE mark, we do not produce under our own trademark, but we are subcontractors (producing for the client, semifinished (unsterile) products).

Our cliet is asking for a Certificate of Conformity to be sent with every shipment and this document to be included in our Quality Assurance System.

So I was wondering if this is correct, if I can include it in the system and issue it even though we do not have Ce mark?

Thank you, wishing you all lovely day,
kapinka
 

Marcelo

Inactive Registered Visitor
#17
A ""Declaration" of confotmity" is a regulatory document required by the medical device directive and other directives.

On the other hand, a ""Certificate" of Conformity" is something which might be issued for anything by anybody, in principle. When inside a certification scheme, it has to hava some kind of traceability, for example.

But you can also issued your own certificate of conformity if you or your client wants. This seems what your client wnats, that you have an internal document in which you claim conformance to something.
 

kapinka

Starting to get Involved
#18
Correct, they want internal document, we have already e-mailed one to them for approval and they didn't like the content in it, "too much information in it" they said, so I took off the parts "identification of manufacturer" and "customer information". I'm not quite sure if there is some prescriptive right for the content of CoC.
 

Marcelo

Inactive Registered Visitor
#19
Well, you might ask you client exactly what he wants in this declaration of conformance, as he is the one asking for it.

Anyway, there´s a standards which might help (i´ve never seem it´s contents so i´m not totally sure): ISO/IEC 17050-1:2004 - Conformity assessment -- Supplier's declaration of conformity -- Part 1: General requirements
Media and price
 
P

Persson - 2010

#20
A ""Declaration" of confotmity" is a regulatory document required by the medical device directive and other directives.

On the other hand, a ""Certificate" of Conformity" is something which might be issued for anything by anybody, in principle. When inside a certification scheme, it has to hava some kind of traceability, for example.

But you can also issued your own certificate of conformity if you or your client wants. This seems what your client wnats, that you have an internal document in which you claim conformance to something.
Although I have never seen a "Certificate of Conformity" myself. According to the information update we receive periodically from our EC Rep, Wellkang Tech Consulting in London, UK, the "Certificate of Conformity" seems to be a kind of certificates issued by a Notified Body, this is what Wellkang says on its website:
http://www.ce-marking.com/medical-d...issue-under-3-medical-devices-directives.html

Hope this helps.
 
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