Another Tech File Question
Another Tech File Question
(OP)
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
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





RE: Another Tech File Question
A copy also has to be held by the manufacture etc. so I would put this question to the notified body.
The purpose of the manufacture of their representative being established in the EC is so that someone responsible for the equipment is within the scope of the EC's jurisdiction in case any thing goes wrong, so whomever you choose needs to be told that they are legally responsible for the equipment (and probably have to serve the jail sentence that follows a successful prosecution in the event of a fatal error).
RE: Another Tech File Question
RE: Another Tech File Question
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.
RE: Another Tech File Question
RE: Another Tech File Question
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
RE: Another Tech File Question
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.
RE: Another Tech File Question
Christopher Caserta
ccaserta@us.tuv.com
Ph:904-225-0360
RE: Another Tech File Question
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).