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Requirements for Declaration of Conformity - Compliance to MDD


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Some Related Topic Tags (Not all threads are Tagged)
declaration of conformity, mdd requirements, mdd (medical device directive)
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  Post Number #1  
Old 25th September 2007, 11:12 AM
temujin's Avatar
temujin

 
 
Total Posts: 165
Please Help! Requirements for Declaration of Conformity - Compliance to MDD

Hi Folks,

A basic question at the end o fthe day, (at least for me...)

What exactly are the requirements for the content of the Declaration of Conformity? (Apart from the list of standards used to prove compliance to MDD)?

Appended:I mean compliance to the Medical Device Directive - 93/42/EEC

best regards
t.

Last edited by temujin; 25th September 2007 at 02:54 PM.

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  Post Number #2  
Old 25th September 2007, 11:15 AM
ScottK's Avatar
ScottK

 
 
Total Posts: 2,584
Re: Requirements for Declaration of Conformity

what directive(s) are you following?

My company CE Marks to 97/23/EC (pressure equipment directive) and there is an annex detailing the requirements.

http://ec.europa.eu/enterprise/press...annex7_en.html
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  Post Number #3  
Old 25th September 2007, 05:32 PM
DannyK

 
 
Total Posts: 666
Re: Requirements for Declaration of Conformity - Compliance to MDD

The Declaration of Conformity is a legal document which indicates that the manuafacturer or his authorized representative fulfills the obligations imposed in the applicable annex. (product satisfies the essential requirements, products are designed, manufactured and tested in accordance with technical documents)

The name of the manufacturer and address, details of product, conformity assessment route, statement that devices comply and time based control are required to be included.
Thank You to DannyK for your informative Post and/or Attachment!
  Post Number #4  
Old 26th September 2007, 01:05 PM
Roland Cooke

 
 
Total Posts: 613
Re: Requirements for Declaration of Conformity - Compliance to MDD

I would expect to see an individual identified, and signing the document on behalf of the company. It is a legal document after all.

(I would tend to then confirm that the signer actually understood what it was that he/she was signing, but that's another matter!)

Some companies have multiple DoCs, one for each product range, sometimes one for each production batch. There are pros and cons with doing that, but legally it's fine.
  Post Number #5  
Old 28th September 2007, 07:03 AM
temujin's Avatar
temujin

 
 
Total Posts: 165
Re: Requirements for Declaration of Conformity - Compliance to MDD

...an additional question:

By googling I have found a number of DoCs with the CE-Mark being on the document, normally as part of the title.

Is there any requirement related to this, (or maybe it should not be used there at all) ?

regards
t.
  Post Number #6  
Old 5th October 2007, 12:38 PM
Roland Cooke

 
 
Total Posts: 613
Re: Requirements for Declaration of Conformity - Compliance to MDD

There was a NB-MED Consensus Statement on the content of DOCs, written years ago, but I'm fairly confident it is still okay.

http://www.meddev.info/

Open up the Consensus statement link, the one you want is S/01/99.


As for putting the CE-mark on things other than certified or self-certified devices and their various levels of packaging, strictly-speaking you shouldn't, and that would apply to the DoC.

Whilst Notified Bodies and CAs don't tend to get too excited about stuff like that, it is better to avoid misplacement of the CE mark wherever possible. After all, do you really want to risk getting a regulatory non-conformance issued against your just-printed 10,000 advertising brochures....?
Thank You to Roland Cooke for your informative Post and/or Attachment!
  Post Number #7  
Old 5th October 2007, 04:09 PM
wrodnigg's Avatar
wrodnigg

 
 
Total Posts: 254
Re: Requirements for Declaration of Conformity - Compliance to MDD

The required content of a declaration of conformity is specified in Annex VII of the MDD 93/42/ECC.

There also two Standards according to this topic:
EN ISO 17050-1, EN ISO 17050-2

Additional information can be found in the Blue Guide [dead hyperlink removed Dec 2016].

And finally notified body consensus statement S/01/99 on “Declaration of conformity” (attached file)
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf NBMED Declaration of Conformity.pdf (77.7 KB, 1056 views)

Last edited by Ronen E; 13th December 2016 at 09:43 PM. Reason: Removed dead hyperlink.
Thank You to wrodnigg for your informative Post and/or Attachment!
  Post Number #8  
Old 10th March 2009, 08:07 PM
Persson - 2010

 
 
Total Posts: 40
Re: Requirements for Declaration of Conformity - Compliance to MDD

Quote:
In Reply to Parent Post by Roland Cooke View Post

There was a NB-MED Consensus Statement on the content of DOCs, written years ago, but I'm fairly confident it is still okay.

http://www.meddev.info/

?
The newest (August 2008) required content for DoC are:

-----------------------------------------------------------
EC DECLARATION OF CONFORMITY

1.
No xxxxxx (unique identification of the product):

2.
Name and address of the manufacturer and/or his authorised representative:

3.
This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):

4.
Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):

5.
The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: ………

6.
References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:

7.
Where applicable, the notified body ... (name, number)… performed … (description of intervention) … and issued the certificate: ….

8.
Additional information:

Signed for and on behalf of: ………………………….

(place and date of issue)

(name, function) (signature)

-----------------------------------------------------------
Thanks to Persson - 2010 for your informative Post and/or Attachment!
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