Another Tech File Question 2

[Mike4321]

The directives say that the technical file must be kept by the manufacturer or representitive established in the community.

What is meant by "established"? Does that mean located in Europe or just recognized by the standard authorities there.

I'm assuming it means located in Europe. I'm located in Canada and we generally ship our product to customers ourselves and have our own employees install it. So we are the ones placing in the European market.

My question is where should the technical file be kept? (We had the testing done by the ITS Lab in Toronto, ITS has a location in the UK that is recognized as a notified body - would they keep the Tech File?)

Thanks

 

[buzzp]

I agree with Fawkes. However, the manufacturers rep in the EU has to hold the technical file. Now I am not sure about you, but I would not want to give this info to a distributor or sales rep in the EU because this is important info that I would not want in the wrong hands. What I do, is keep the Technical File in the US (as well as several other companies I know) and have no authorized rep in the EU. Now, technically, this may not be okay but the file is readily available to the authorities should they need it (by way of electronic copy ,etc). I think this requirement (to have authority in EU) is a bit dated since communications nowadays is so easily accomplished. I believe this requirement was instituted in the days before computers were so widely used (could be wrong). I did an awful lot of research in this area and technically your supposed to have a rep in the EU but I believe the authorities would understand my perspective (as well as many other companies).

 

[CurtB]

Buzzp,
I assume that we are discussing the Machinery Directive 98/37/EC
Some of your statements I partially agree with…
// the manufacturers rep in the EU has to hold the technical file\ This is true.
// I would not want to give this info to a distributor or sales rep in the EU\I agree also… however,
// What I do, is keep the Technical File in the US (as well as several other companies I know) and have no authorized rep in the EU\This is NOT the same understanding that I have. I believe that the reason a “manufacturer or representative established in the community” is required is so that there is someone liable in the EU for the product in case it fails to meet the applicable standard(s). There are several cases where persons are fined for non-conforming equipment and if you are outside the EU it is rather difficult to enforce a fine on you. If you do not have an manufacturer or representative established in the EU I would suggest you get someone that you can depend on. Also, their name should be on the declaration of conformity that you ship with your equipment.

 

[buzzp]

I am not referring to the machinery directive. I am aware of the technical file being located in the EU with an authorized rep. This is required as I understand it. I do know of several companies who do not do this. I have consulted with several experts in this area and it seems that not having an authorized rep is becoming common for importers. This determination should be made on a individual basis but technically, yes you need an authorized rep in the EU. So I do agree with CurtB but given the self regulation of the CE mark and the impracticallity of an authorized rep for smaller companies, many do not have an authorized rep. Yes this is still wrong and not the way it should be done.

 

[ccaserta]

I agree with CurtB, it depends on what type of product and Directive you fall under. Only the Directives that require a Notified Body license/certificate are required to have a copy of the Technical File on EU soil. Normally the Notified Body keeps a copy of the file, this is sufficient for EU soil. All other Directives like Low Voltage, EMC, Machinery Annex I, Toy and others that do not require a Notified Body License can be kept in the orignating country. I also know of very many companies who keep their own Files in the US, Cnanda, Brazil etc. I Know because that how I set them up for my customers as a Notified Body.

Mike4321, ITS should have been able to tell you this, if you need more specific info let me know.

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

 

[abbver98]

Mike4321
Technical files had to be kept by the representitive or the person responsible established in the community only when you apply module that doesn't require a quality system PED certification. For example, module A and A1. (I have experience with our supplier in US and Japan who supply sometimes with D1 module (no tech file)).
ITS could do it for you they accepted (this in case you apply module A or A1). Your representative could do it also.

 

[ccaserta]

abbver98, if Mike has a Pressure Vessel I'm sure you are correct. However those requirements are strictly for PED and donot apply to other products. There are at least 19 Directives that fall under New Approach Directives list. PED is only 1 of the 19. Every Directive is different and aeach has a it's own process that must be followed.

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

 

[abbver98]

ccaserta,

I speak about the PED only. As you say there is other directives. By instance LV, CEM and machinery. I have experience also with the 2 first. We certified the product coming from outside EU. I notice that the application of the conformity modules differ from directive to another (for the same module).