CE Mark Technical File

[Mike4321]

Hello

I'm from Canada and am trying to certify a product for the European market. The ATEX and EMC directives apply to the product.

I've read some guides about CE Marking and some say (for example

http://www.industry.gatech.edu/quality/quality_news_textfile.html

)
that the Technical File should be two parts. Basically one is a small version with no test reports or quality system information and the other is a larger version with everything the small one has plus test reports and quality system information.

The guides on the European Union On-line site (

http://europa.eu.int/comm/enterprise/atex/guide/index.htm)

and the directives themselves make no mention of this. Since these guides are made by the European Commision I would follow them rather than other guides.

Is the two part technical file necessary?
Also would anyone happen to have or know where I could find some example technical files?

Thanks

 

[buzzp]

I have always used one technical file. The so called smaller version they are referring to may be the declaration of conformity.

 

[buzzp]

Technical file requirements include keeping all design data, test results, etc, in one location. Something most people do anyway. I believe if you did not assemble this right away, then no harm done. I believe they are saying you need to provide all requested information in a reasonable amount of time.

 

[pgn]

Hello Mike.

Follow the EU guidelines! I can't see any reasons for a part technical file.

In principle, a technical file must contain all documents that support your statement that the product in question complies with all relevant EU directives.

A technical file very often contains company internal information why it can be difficult to obtain an example.

Rgds
PG Nilsson

 

[ccaserta]

Mike, I agree with Fawkes and Buzzp. The point of CE marking your product is to be able to prove you conform. I wouldn't wait to long to buid a table of context on where the proper documentation can be found. You know how priorities are, before you know there are 5 other things to be done and you lose site of the Technical File. The CE Mark is based on the File and if your company is ever challenged you don't want to be scrambling for information.

Normally your file should consist of reports and test data to support each Directive and standard used to show conformance, your company Product Licenses and Certificates if applicable, Photographs, Critical component list with Declarations of confomity or EU license for each critical component, All design information (Ratings, Schematics, layout drawings, mechnaical drawings etc.)Installation, Operation, Maintenance and Service manuals, Photographs and any other inhouse test data or safety critical information.

Christopher Caserta
ccaserta@us.tuv.com
Ph:904-225-0360

 

[stephenweinstein]

You are required to have all required information in the file. You are not required to organize it in two parts as you described. However, it is to you advantage to not have information that you consider proprietary or confidential and information that is likely to be requested by the authorities in the same part. This is so that you can provide them with the part(s) containing the requested information without providing the part(s) with the proprietary or confidential information.

 

[stephenweinstein]

Some Directives require both (1) documentation that your design or prototype is acceptable and (2) documentation that what you make in mass production will match the design or prototype. It makes sense to do this in two parts, but I do not know of a requirement to separate them. Also, the second of these two applies only to series manufacture (mass production) and is not applicable if you only make one. For example, the Machinery Directive requires:
(a) a technical construction file comprising:

- an overall drawing of the machinery together with drawings of the control circuits,

- full detailed drawings, accompanied by any calculation notes, test results, etc., required to check the conformity of the machinery with the essential health and safety requirements,

- a list of:

- the essential requirements of this Directive,

- standards, and

- other technical specifications, which were used when the machinery was designed,

- a description of methods adopted to eliminate hazards presented by the machinery,

- if he so desires, any technical report or certificate obtained from a competent body or laboratory (1),

- if he declares conformity with a harmonised standard which provides therefor, any technical report giving the results of tests carried out at his choice either by himself or by a competent body or laboratory (2),

- a copy of the instructions for the machinery;

(b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.

 

[stephenweinstein]

See "USEFUL FACTS IN RELATION TO THE MACHINERY DIRECTIVE 98/37/EC" (

http://europa.eu.int/comm/enterprise/mechan_equipment/machinery/facts.pdf)

page 17, Answer 63, which begins "The Directive does not require the technical file to be in two parts. The confusion probably stems from reading the general vade-mecum on the new approach, but this was drawn up in order to make it easier to apply Directives that are vague on one point or another, which is not the case with the Directive on machinery, at least insofar as the technical file is concerned."