Dear Cove,

I know from previous posts that the Declaration of Conformity" is a document with legal status.

Does anyone know the consequences of this?
Is it different signing a Doc that to sign i.e. a Biocompatibility test report? a design review document etc.?
Is the responsibility/liability of the signatory other that for other documents?

best regards
t.

Depending on which standard we're referring to, I have read the consequences can be severe. I expect they would vary from one locale and country to the next, and would be based on the risks to the customer.

For example, if a biomedical company declared it was in conformance with clean room requirements and was found to have no controls, the penalties for this misrepresentation could be based on both context (fraud) and damages (contaminated products caused infections that killed people).

Any one else have more specific input for this?

Dear Cove,

I know from previous posts that the Declaration of Conformity" is a document with legal status.

Does anyone know the consequences of this?
Is it different signing a Doc that to sign i.e. a Biocompatibility test report? a design review document etc.?
Is the responsibility/liability of the signatory other that for other documents?

best regards
t.

Temujin,

Your query is posted under the head CE marking / CB scheme while you talk regarding biocompatilbility. It would help if you provide further details regarding the type of product / usage you are referring to.

CE marking is done for a product and the declaration of conformity is issued by the manufacturer where allowed, else by specifically listed third parties for a limited but sensitive list of products. The declaration of conformity is a certification that the product has been designed and built to meet all specified safety related standards for the same. These standards are listed in the dclaration. The signatory is liable to compensate any damage to any human being that might occur while the product is in use within the EU.

The CB scheme has a very limited purvue. To my knowledge, it covers only electronic industry ( I may be time barred on this). This is only a certification by an NCB that a sample product that was submitted to it for testing meets certain norms. This can be used as an attachment and proof as a part of the CE documentation. The authority signing the CB certificate does not issue the declaration of conformity as envisaged by CE - and is in no way legally liable.

Dear Cove,

I know from previous posts that the Declaration of Conformity" is a document with legal status.

Does anyone know the consequences of this?
Is it different signing a Doc that to sign i.e. a Biocompatibility test report? a design review document etc.?
Is the responsibility/liability of the signatory other that for other documents?

best regards
t.
A declaration of conformity only has legal status in terms of the contract to supply. So if, for example, you have no contract to supply then the declaration has no significant status (except in your own market where any advertising or declaration may make implied terms of contract).

Regarding the EU and directives the responsibility under most of these directives is for the importer to ensure they comply with the laws in their country (as developed from EU directives). How they do that varies between directives.

One of the ways of demonstrating they have taken all reasonable steps to comply is by requiring any supplier from outside the EU to provide products that comply. They can again use a variety of means of doing that but most EU purchasers will at least make it a contractual requirement that products conform with relevant directive(s). As soon as it is a contractual requirement the declaration may be used as evidence that the supplier is providing products that conform with directives.

If products are found to be non-compliant then the declaration is likely to be used as evidence in a contract law dispute. So if, for example, the product you make injures someone then the importer is likely to be prosecuted under the local law (which meets the EU directive) and they are likely to try to recover those costs from the manufacturer under the terms of their contract.

I hope this helps!

I'm verry interested in this subject.
Could some on tell me if this declaration of conformity needs to be backed up by proof, e.g. testing by third party, or not? I know that proof is not usualy sent to client, but in case he asks for it I must give him proof or not.
More specific, if some one knows Romanian food package regulations, or EC for that mather, could you tell me if I need to supply proof of my declaration of conformity or it's up to the client to prove that the product does not meet the specification in it.

I'm verry interested in this subject.
Could some on tell me if this declaration of conformity needs to be backed up by proof, e.g. testing by third party, or not? I know that proof is not usualy sent to client, but in case he asks for it I must give him proof or not.
More specific, if some one knows Romanian food package regulations, or EC for that mather, could you tell me if I need to supply proof of my declaration of conformity or it's up to the client to prove that the product does not meet the specification in it.


We write D of C's all the time for the Pressure Equipment Directive 97/23/EC.
This directive contains in Annex VII exactly what needs to be included in a D of C.
http://ec.europa.eu/enterprise/pressure_equipment/ped/directive/directive_annex7_en.html
This is the only directive we CE mark to, so I can't speak for others. I would think other directives would have a similar annex defining D of C's.

Yes, the DoC needs to be backed up by proof. The proof would be compiled in what is called a "Technical File", a "Technical Construction File" or "Technical Documentation" depending on which directive you read.

It pretty much works like this:
With the CE marking you indicate that your product complies. With the DoC you specify with which directive(s) and standards the product complies. The Technical File will contain all documents with which you can prove the product meets the different requirements in the directives and standards.

About the legal implications of the DoC there are some discussions. In my view, the DoC is a statement by a company official on company letterhead (and with a signature). This can be used in a legal case (false statement), should the product not be in conformity.

Han