May I also refer to the earlier parts of this discussion ?
- The competent body has been repealed and will not be used
anymore.
- Every EMC related ce marking may be entirely carried out
by the manufacturer
- The Notified Body comes in place of CB and becomes a voluntary route.
- What was called technical construction file before is more or less
what is required now for EVERY product.
- A separate evaluation called "EMC assessment" is required
for EVERY product but :
-- applying ALL applicable harmonised standards is defined
equivalent to carrying out an assessment
-- the technical documentation should show (not prove) compliance
with the essential requirements
(the latter to cover for incomplete harmonised standards not covering
all phenomena, or not all relevant frequency ranges)
(these 2 rules are not fully inline and allow for interpretation
both authorities an manufacturers will read this differently !!)
The differences are that :
- more documentation must be made up, but most manufacturers
will have most information at hand.
- the files do not have to reside on EC soil anymore.
- the representative's signature has been deleted from the DoC requirements
The following has been copied from my earlier contributions:
==================================================
The basis of CE is trust.
The legal framework requires manufacturers to accept liability, by signing
up a legal document that is called EC declaration of Compliance.
CE marking without EC Doc is an economical type of fraud.
In Europe that is a serious type of Fraud, that ultimately may lead to
fiscal authorities come over and empty your administrative department,
searching for much more then just a piece of illegal marked equipment.
CE marking is a manufacturer initiated process, not a testimonial type
approval such as VDE of TUV marking. No one backs up your DoC, even if you
use VDE (just an example) itself (f.a.) to do your testing.
Even if the testing agency make a huge mistake, the manufacturer remains
liable for all consequences.
A CE-mark that has been backed up by a ECDoc proves the authorities (and
thus customers) that a manufacturer is liable to all failure of compliance.
Getting your right is a relatively easy route in legal sense.
There is no obligation to test whatsoever, as long as the manufacturer
accepts liability. This has lead to a situation where a risk assessment
showed less scrupulous manufacturers that selling without testing is an
acceptable option.
To reduce this the new EMCD will require a technical documentation proving
compliance in addition to the ECDoC.
So what needs to be proved?
All CE marking directives (called NEW APPROACH) require compliance to
Essential Requirements.
These are simple phrases exactly formulating the GOAL of the directive
(Annex I).
Differently to other type of legislations, where exact rules are specified
(such as automotive
directive) , making those legislation susceptible to aging, and creating
loopholes for new technologies, this approach is inherently resistant to
aging.
One of the methods to get a presumption of compliance to the GOALS of the
directive is to show compliance to market driven and EC approved harmonized
standards.
If one of these standards fail to cover the GOALS of the directive,
compliance is NOT achieved.
The NEW EMCD will in emphasize this addition to proving compliance with
standards by requiring the manufacturer to show compliance with the GOALS of
the directive in Annex II point 3.
Hope this shines even more light on CE-marking and old and new EMCD.
Regards,
Gert Gremmen
Approvals manager
======================================================
ce-test, qualified testing
Member of EMC committee CENELEC/IEC
+ Independent Consultancy Services
+ Compliance Testing and Design for CE
+ Improvement of product quality and reliability
+ Testing services according to:
Electro magnetic Compatibility 89/336/EC
Electrical Safety 73/23/EC
Medical Devices 93/42/EC
Radio & Telecommunication Terminal equipment 99/5/EC
Website: www.ce-test.nl
Phone : +31 10 415 24 26
Fax : +31 10 415 49 53
======================================================
FW>-----Original Message-----
FW>From: [email protected] [mailto:owner-emc-
FW>[email protected]] On Behalf Of T.Sato
FW>Sent: zaterdag 15 januari 2005 03:16
FW>To: [email protected]
FW>Subject: Re: New EMC directive
FW>
FW>On Fri, 14 Jan 2005 15:31:40 -0800,
FW> "Jim Eichner" <[email protected]> wrote:
FW>
FW>> The one thing I thought they were going to change that was significant,
FW>> turns out not to have been changed. There had been some discussions
FW>> about allowing the Essential Requirements (TCF) route to compliance (as
FW>> opposed to the harmonized standards route) to be used withOUT the
FW>> involvement of a Notified Body, but the new Directive still requires a
FW>> Notified Body.
FW>
FW>I think that the involvement of a competent body (now notified body)
FW>will become no longer required under the new EMCD.
FW>Manufacturers may ask the notified body AT THE DISCRETION OF THE
FW>MANUFACTURER.
FW>Please read Article 7, and (15) in the "whereas" section of the
FW>Directive.
FW>
FW>Another changes, already manufacturers may already do that, are:
FW>
FW> - Manufacturers must draw up a technical documentation even if
FW> harmonized standards are fully applied, and the technical
FW> documentation and DoC must be held in the Community territory.
FW>
FW> - Name and address of the manufacturer, and of the representative
FW> in the Community if the manufacturer is not in the Community,
FW> will become required.
FW>
FW>Regards,
FW>Tom
FW>
FW>--------------------------------------------------
FW>Tomonori Sato <[email protected]>
FW>URL: http://homepage3.nifty.com/tsato/
FW>
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