Requirements for Declaration of Conformity - Compliance to MDD

[temujin]

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.

[ScottK]

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

[DannyK]

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.

[Roland Cooke]

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.

[temujin]

...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.

[Roland Cooke]

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....?

[wrodnigg]

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 [URL="http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm"]Blue Guide.
[/URL

And finally notified body consensus statement S/01/99 on “Declaration of conformity” (attached file)

[Persson]

Originally Posted by Roland Cooke

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:

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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)

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