Documentation for CE 6

[BruceAxtell]

Has anyone done the self-declaration technical file for products going into Europe?&nbsp;&nbsp;Can you provide any information about the process?&nbsp;&nbsp;Thanks.<br><br>Bruce

 

[wrjohnst]

I have prepared a couple CE Technical Files. I see that you entry was May of 2000, are you still interested in making a Technical File?

 

[BruceAxtell]

Yes, I'm still interested. I don't have anything to declare at the moment, but anticipate so in the future and would like to get a heads up as to what is involcved.

Thanks.

Bruce

 

[koolkid]

I do want to get spec for CE qualification. Any lead or links are welcome.

 

[wrjohnst]

CE Self-Certification is the process by which a company documents that their product or machine conforms to the relevant requirements. Applying the CE Mark to your machine or product indicates that the equipment complies. The manufacturer must provide a Declaration of Conformity with the machine or Declaration of Incorporation for parts of a machine. This Declaration describes the machine and lists the Directives and EN Standards that the mahcine or product conforms to. Additionally the manufacturer must put together a Technical File or Technical Construction File that contains the documentation the supports the claims to conformity.

The first step is to determine which EU Directives apply to your machine or product. EU Directives describe the general requirements (usually safety). The manufacturer should use the appropriate harmonized (EN) standards to demonstrate compliance with the relevant directives. It is not necessary to use EN standards but it would be more difficult to demostrate conformance without them. Small special purpose equipment may only need to conform to one directive where larger machines will probably need to comply with a couple of directives i.e. 98/37/EC Safety of Machinery, 73/23/EEC Low voltage equipment, and 89/336/EEC EMC.

A good place to start is at the offical EU site, (

http://www.newapproach.org/directiveList.asp

). This site lists the directives (which can be downloaded at no charge) and their harmonized standards (standards have to be purchased). If your company belongs to any trade groups check with them, they will usually have some good information for you. The European Commission has published a document &quot;Guide to the Implementation of directives based on the New Approach and the Global Approach&quot; which is free. I don't have the web address but it may be available on the newapproach website mentioned above. The NIST also publishes a free document &quot;NIST Special Publication 951, A Guide to EU Standards and Conformity Assessment&quot;. This is available at (

http://ts.nist.gov/ts/htdocs/210/217/eu-guide/sp951.htm

).

 

[koolkid]

Thank you wrjohnst for the links. I also did a search for EN/IEC-61000 standard and found their site, bought and download a standard, and did a SPICE simulation to make sure of EFT conformity. I had to pay 89 Swiss franks but that's a cost of doing business. I'm the company, shuck . I didn't think IEEE or SAE would have the authority to resell them at member discount so I went ahead, downloaded and got the job done quickly.

 

[AshShepley]

I am involved in self cert CE marking of a range of machinery and electrical equipment. Should you still require information let me know and i will try and help. Difficult to give a blow by blow account as i am sure you will appreciate the complexity.

 

[ccaserta]

Hi I just joined the website, my main expertise is in European certifications (CE Mark). As you probably have already found out. You can only CE Mark a product if it falls under one of the &quot;New Approach Directives&quot;, most likely there are at least 2 if not 3 Directives your product will fall under. You are required by law to show conformance to all applicable standards. To show conformance you must Build a TCF (Technical Construction File) as mentioned by wrjohnst. To build a TCF you will need the applicable standards assessments, Safety and EMC test data, Critical components list, all the Declarations of Conformity and EU licenses for the critical components, Complete design information, Manuals for operations, maintenance, service,(if its machinery in designated countries language except for service manual), and photographs. For more details and appropriate standards give me a call. There is to much detail to this process to list everything that's necessary. Christopher Caserta
Sr. Regulatory Engineer
ccaserta@enorthhampton.com
Ph:904-225-0360
Fax:904-225-0340

 

[buzzp]

Worth noting: You can not self declare if there is no harmonized standard that would encompass your product. You can test on your own but the results would need to be reviewed and approved by a notified body. Also, if you read all the literature and standards they all say that you need an authorized rep in the EU to be responsible for your product. However, I have read cases where the company has the relevant documenation on their server and at the request of an EU authority would give the files over to them. I have learned that most US companies and some EU countries do not take CE marking seriously. This will continue to be the case until enforcement efforts are increased or the company suffers a law suit due to injury. These companies I refer to are large motor control companies (top 5). I had to be the CE expert for one of them that was private labeling our product and they were already selling numerous products to the EU. And believe me, I am no expert. I had to teach myself by reading the standards. I am sure you agree, interpretting standards (especially EU standards) is a pain in the neck.

 

[ccaserta]

Sorry no offense buzzp, All products have a standard, if it's not an EN you can use an IEC even a DIN. Use a standard that closely fits your product if no other is available.The point is to try to meet the essential safety requirements. If your product falls under one of the new Approach Directives you must CE mark. There is no requirement to use a Notified Body unless the product is a Invasive medical devie, falls into Anex IV of the Machinery Directive, is Explosive Atmosphere or possible a pressure vessel. Most all other products can be self Declared by the manufacture or like you said tested inhouse as long as the appropriate standards and test are provided. As far as a representative on EU soil this is only true for Type Approvals not for the CE Mark. A manufacture must hold the TCF (Technical Construction File)for 10 years after the last model is put into the market place. The file can be kept at the manufactures facility wherever that facility is.

Your right about people taking the mark seriously but it's changing, I'm finding that more and more companies are because the market (customers)are requesting it. I've also found that large manufactures who build product for the US are trying to standardize their Bill of materials which initiates the questioning of the CE certification and the need to start conforming.
Sorry for the long response! Christopher Caserta
Sr. Regulatory Engineer
ccaserta@enorthhampton.com
Ph:904-225-0360
Fax:904-225-0340

 

[buzzp]

Thanks for the clarification!