CE Mark source

M

Thread Starter

M.Farzad

Hello List,

The manufacturer of some medical equipment we use claims that the products have CE approval but we want to confirm this subject directly from CE
organization.So if it is possible lead us directly to the organization which gives the CE approval to the products. Thank you very much for your cooperation and remain yours.

Best regards
M.Farzad
General manager
 
R

R A Peterson

I think if you do a bit of research you will find that there is no CE organization. It is not a testing lab like UL or FM, and as such there is no
"CE approval".

Compliance with CE directives can be confirmed either through in house or external sources.

As best I can tell you, putting the CE mark on a product is akin to 'certifying" drawings. It is basically meaningless but is an extra step the
manufacturer takes to say that he is in compliance with certain requirements.
 
L

List Management Account

The manufacture must issue the EC Declaration of Conformity and in turn file the EC Declaration of Conformity in such a way as to make the information available to "national authorities" for a period of no less then five years after the last product was manufactured. This
documentation consists of test reports, drawings, risk analysis, standards applied, etc. Usually the manufacturer contracts to an European Union Competent Body representative to present this
information and obtain the CE mark indicating compliance.
 
B
The European Community does not have an authority which actually approves equipment by providing CE marking. CE actually stands for 'Conformit=E9 Europ=E9en' or European Conformity. The person or
legal entity (eg the supplying company) who affixes the CE marking on the product is legally responsible for the claimed compliance with the appropriate directives.

Normally that person would be resident in Europe and in the case of equipment manufactured outside the EEA, the agent who places the product on the market becomes responsible. When a product is
legitimately CE marked, the product may be offered for sale throughout the EEA without further need for testing. However, the national authorities that control the sale, circulation and use of industrial equipment are entitled to check that CE marking schemes are being properly used. Where the CE marking arrangements have not been properly applied, prosecution can follow. Misleading use of the CE mark is prohibited.

So basically, the answer to your question would be that there is no one other than the vendor, who can vouch for the validity of the CE mark.
If the vendor had CE marked his equipment and it did not comply with the various European directives then he could be prosecuted.

Hope this helps!

Bryan Weir.
 
B

Boyes, Walt/SeaMetrics

Well, yes and no. There is no CE mark organization, but it isn't exactly the same thing as certifying drawings. You can "self-certify" CE
compliance, but if you are not a manufacturer based in the European Community, you are begging your competitors to ask their respective customs
people to bag your stuff until you _prove_ compliance. Now, nobody would do that, just to harass you, would they? <evil laugh> Or just to scare people into buying from a good, european vendor?

CE compliance testing isn't as expensive as it was at first, and there are multiple lab venues around the world who do it, not just UL and FM and CSA, etc.

It is cheaper to have the testing done so an independent lab can "certify" compliance.

Walt Boyes

------------------Walt Boyes----------------
SeaMetrics Inc. Flow Meters and Controls
P. O. Box 1589 Kent, WA 98035 USA
253-872-0284 voice 253-872-0285 fax
mailto:[email protected]
http://www.seametrics.com
------------------------------------------
 
G
Even though the CE mark has been around for a while now there are still a lot of confused people even in Europe about what it means.

I don't claim to be the world's greatest expert but as a manufacturer of product in Europe I have had to navigate this subject a little.

I will try to add a little to the information already given to put this into some context.

It is a legal requirement that every product (yes EVERY product) sold in the EC carries the CE mark.

Please note here, this is a HEAVY legal requirement. The legislation states that authorities may impose prison sentences and / or fines on INDIVIDUALS within companies found responsible for placing non-compliant products on the market.

It isn't just a corporate slap on the wrist for the owners of the company, it can be applied to designers, production staff, installers etc if they cannot prove they showed "due diligence" in ensuring that the product complied with all necessary directives.

(It should also be worth noting that the legislation is designed to apply just as harshly to a purchaser who does not ensure that a product he buys is fully compliant. Generally speaking, he will guarantee this by asking the supplier to provide copies of certification.)

So anyone purchasing CE marked equipment from non-member states is likely to be very keen to see very convincing certification (why should I carry the can if I find that the CE marked product I buy in from Bongo-Bongo kills somebody because it doesn't meet the required standards?).

The CE mark indicates that the product complies with ALL NECESSARY European Directives.

It is up to the individual to find out which directives he needs to comply with, this depends on the nature of the product and its intended
application.

For instance, at the moment our products have to comply with the Low Voltage Directive and the EMC directive.

Both of these directives define broad objectives for electrical safety, emissions and interference. Depending upon the type of equipment you are talking about and the environment you are going to put it into, you then
need to select a list of European standards (which define very precise tests and the required results) which you test against.

When you pass these tests you have proved you comply with the standards and hence you comply with the various directive.

You are then legally entitled to afix the CE mark to your product.

You can perform the tests yourself and record the results in what is called a Technical Construction File or you can have the tests preformed by independant certified laboratories. The choice is yours and may often depend on your available budget and on how often you think you are going to be repeating the process.

A word of warning on self certification.

The letter of the law is you must show "due diligence". It seems the courts are most willing to believe you have shown due dilligence if you have had your results verified by a certified test house.

The whole CE issue is very hazy. This is because it deals with directives which in themselves do not relate to standards but instead define a range of objectives which will mean different things under different sets of circumstances.

Its comforting to know you just need to look for one mark on say a toy to know that it is safe instead of having to know what a dozen different
standards symbols mean, but it makes the manufactures life a little more awkward when you're trying to work out which standards you need to comply with.

By the way, don't be fooled into thinking that if you build a product from CE marked components the finished product automatically adopts the CE mark.

If you don't have a compliance consultant to hand the best sources are the standards institutes in member states, they can point you towards people on the relevant committees.

Try the British Standards Institute in the UK or National Standards Institute of Ireland here in Ireland.

Prosecutions for CE mark fraud are not all that common in the UK and Ireland, mostly because of the enormous resources that would be required by
governments of member states to try to check out every new product that comes on to the market, but the CE marking issue is used as a marketing/propaganda tool when other competitive advantages run out.

Hope this is of some help to somebody

Regards

Geoff Moore

Straight Forward Solutions Ltd
Maynooth Road, Prosperous, Naas,
Co.Kildare, Ireland
+353 (0)45 892739
[email protected]


----- Original Message -----
From: Boyes, Walt/SeaMetrics <[email protected]>

> Well, yes and no. There is no CE mark organization, but it isn't exactly
> the same thing as certifying drawings. You can "self-certify" CE
> compliance, but if you are not a manufacturer based in the European
> Community, you are begging your competitors to ask their respective
> customs people to bag your stuff until you _prove_ compliance. ...<clip>
 
R
> Please note here, this is a HEAVY legal requirement. The legislation states
> that authorities may impose prison sentences and / or fines on INDIVIDUALS
> within companies found responsible for placing non-compliant products on the
> market.

Prison sentences etc. (i.e. criminal offecences) come about by marking products falsely with the CE mark.
Not putting the CE mark is a lesser offence.

> It isn't just a corporate slap on the wrist for the owners of the company,
> it can be applied to designers, production staff, installers etc if they
> cannot prove they showed "due diligence" in ensuring that the product
> complied with all necessary directives.

Umm... Certainly not in Italy, a normal employee cannot be held responsible for a companys action. A Director (i.e. the technical director) yes, and I believe certain other management grades (such as
quadri) are held responsible for violation. Normally it is the Technical director or higher who 'declares' the apparatus to be compliant, on the basis of tests carried out by an accredated laboratory.

> (It should also be worth noting that the legislation is designed to apply
> just as harshly to a purchaser who does not ensure that a product he buys is
> fully compliant. Generally speaking, he will guarantee this by asking the
> supplier to provide copies of certification.)
>
> So anyone purchasing CE marked equipment from non-member states is likely to
> be very keen to see very convincing certification (why should I carry the
> can if I find that the CE marked product I buy in from Bongo-Bongo kills
> somebody because it doesn't meet the required standards?).
>
> The CE mark indicates that the product complies with ALL NECESSARY European
> Directives.
>
> It is up to the individual to find out which directives he needs to comply
> with, this depends on the nature of the product and its intended
> application.
>
> For instance, at the moment our products have to comply with the Low Voltage
> Directive and the EMC directive.

Note: Low voltage means 230V, not 24V.

> You can perform the tests yourself and record the results in what is called
> a Technical Construction File or you can have the tests preformed by
> independant certified laboratories. The choice is yours and may often depend
> on your available budget and on how often you think you are going to be
> repeating the process.
...
> A word of warning on self certification.
>
> The letter of the law is you must show "due diligence". It seems the courts
> are most willing to believe you have shown due dilligence if you have had
> your results verified by a certified test house.

Self certification is usefull for e.g. modified equipment were you demonstrate that you have not done anything to the product which is likely to influence compatibility.

> Prosecutions for CE mark fraud are not all that common in the UK and
> Ireland, mostly because of the enormous resources that would be required by
> governments of member states to try to check out every new product that
> comes on to the market, but the CE marking issue is used as a
> marketing/propaganda tool when other competitive advantages run out.

I believe the CE mark system RELIES on complaints from competitors.


In Italy there is a branch of the police who specificly deal with CE compliance and radio homogolation.

Shipments of electrical equipment has been blocked at frontiers by customs because of no CE mark.
 
G
>snip>
>
> > Prosecutions for CE mark fraud are not all that common in the UK and
> > Ireland, mostly because of the enormous resources that would be required
by
> > governments of member states to try to check out every new product that
> > comes on to the market, but the CE marking issue is used as a
> > marketing/propaganda tool when other competitive advantages run out.
>
> I believe the CE mark system RELIES on complaints from competitors.

Yes, that's right, the system here is complaints driven, and as you point out, the people who complain most are your competitors, especially if
they've just spent a pile of money getting their products certified!

> In Italy there is a branch of the police who specificly deal with CE
compliance and radio homogolation.
>
> Shipments of electrical equipment has been blocked at frontiers by customs
because of no CE mark.
>

In the UK and Ireland it is the responsibility of trading standards officers. These are local government officials who are also responsible for
a whole lot of other things. Their resources, capabilities and motivations seem to vary quite dramatically from one area to another. I don't keep a very close eye on these things but I have only heard of a couple of prosecutions so far in the UK (and none in Ireland) for CE fraud.

It sounds like things are tougher in Italy!!


Geoff Moore
Straight Forward Solutions Ltd
 
J

Johnson Lukose

<clip>
> Note: Low voltage means 230V, not 24V.
<clip>
In Schneider Electric, anything below 1000V is Low Voltage, 1kV to 66kV is Medium Voltage, 66kV to 132kV is High Voltage and more than 132kV is Extra High Voltage. I believe this is the standard that all electrical utilities and manufacturers use as reference. 24V must be for pussy cats...

thanks.
 
G
That is the same throughout UK/Ireland in the power industry, below 1000v =
low voltage.

As it was explained to me during safety training for UK NGC, low voltages are those which tend to remain within their conductors. Voltages over about 1000v tend to jump out and bite you.


> <clip>
> > Note: Low voltage means 230V, not 24V.
> <clip>
> In Schneider Electric, anything below 1000V is Low Voltage, 1kV to 66kV is
> Medium Voltage, 66kV to 132kV is High Voltage and more than 132kV is Extra
> High Voltage. I believe this is the standard that all electrical
utilities
> and manufacturers use as reference. 24V must be for pussy cats...
>
 
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