After I vent...what is it with all the tech file request?

M

medic61

#1
Hi folks,
I worked hard since 1997 to create the product tech files I have today. Now everyone who is now getting their CE thinks I have to hand them over! Even certain NB suggest our customers obtain copies from us.
Can someone tell me why our competitors shoud have my documents to copy from? The confidential information is not in "part A" but I have still put a lot of work in it.
We have Class IIa dental devices, nothing high level but this "ticks" me off. Anyone have anything to share about this? Is there any other type of document I can send them?
Thanks!
 
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Mark Meer

Trusted Information Resource
#3
Actually, you are not alone. ...and not just with Technical Files.

Several of our customers have requested copies of our SOPs or other quality documents.

We do what we can to deter copying (Non-disclosure Agreements, Watermarked/Locked PDFs, etc.).

...but ultimately there's no getting around that (a) if you want to do business you typically have to provide requested documents; and (b) despite measures above, documents can be copied... Frustrating for the authors to be sure...
 
M

medic61

#4
Thanks Normzone, it mad me laugh ( i dont drink coffee).

Mark I am glad to hear I am not the only one this is happening to.
 

somashekar

Staff member
Admin
#5
Hi folks,
I worked hard since 1997 to create the product tech files I have today. Now everyone who is now getting their CE thinks I have to hand them over! Even certain NB suggest our customers obtain copies from us.
Can someone tell me why our competitors shoud have my documents to copy from? The confidential information is not in "part A" but I have still put a lot of work in it.
We have Class IIa dental devices, nothing high level but this "ticks" me off. Anyone have anything to share about this? Is there any other type of document I can send them?
Thanks!
The intent of the technical file and its review as a part of the CE mark process is vastly different from what seems to be going on with the NB's.
A sort of fear psychosis is dominant than a rational thinking as I see.
You have all the right to decide what design output documents of yours will go into to form the technical file. Add to this the records of approval tests and other tests as applicable to your device. Then the QMS requirements + MDD requirements + PMS requirements.
When NB's want to review this (by there technical reviewer at their office) you end up sending the Files..and requests start flowing for more in pieces.
Demand that your MDD assessor (NB auditor) will review the technical file at your site during the MDD assessment. There is the final DoC anyway which obsolve all responsibilities from the NB and you declare to stand responsible for your devices for safety and effectiveness.
As regard to technical file to customer., a big NO. The OBL CE process ties you up again for the product safety and effectiveness anyway. Are you referring to OBL customer ?
You will be lucky if you find a NB who is with you on these.....
Let me know and I will also change by NB.
 
Last edited:
C

CBAL08

#6
Its been some years working in the field but non of Our Customer( Specially the big OEMS) have asked us Our technical files. Its strange that they have asked and that the NB supports it?
 
M

medic61

#7
Update:
This customer is not a big competitor (not an actual manufacturer) but a family owned company who hired a consultant to help him get his CE. I have worked with this consulting company before and yes, they try to get the process instructions from us but we refuse.

No, we do not label for them at our facility.

Second email I received said I don't need to send the files if I can submit "the Notified Body's report from the OEM's technical file review" I have never heard of this report and feel like it is specific to a NB?

It seems like our quallity certificates don't mean anything, used to mean that your system and tech files were audited and that was enough.

Any further comments will be welcome.
 
Q

Quarma

#8
The requirement has to do with the legal manufacturer. If you are the legal manufacturer, then you need to hold a complete technical file. If the label says:
Manufacturered by "OEM" for "Distributor", then the distributor has no responsibilities and does not need a technical file (no need to request copies).
If the distributor wants to hide that you manufactured it, and states that he is the legal manufacturer (manufactured by "distributor"), then he will request the technical file from you, as the NB wants him to have one. There used to be the situation, that you could refer to someone holding a CE cert for a certain device and the NB could then accept with a declaration of identity, that your NB has reviewed your technical file - and then they want to see the report of your NB for the device, which the German authorities expect to see (until now not all NB do a specific report for the review of the technical file, but the remaining NB after the big cleanup will). So whenever someone wants a TF file from you, he wants to market the device under his name - or wants to copy your device.
Just tell him to label: Manufacturered by "OEM" for "Distributor" and then there is no need for coping of technical files. (I would not give them out either)
 
A

Ariel W

#9
Many years ago I received a study protocol template from a colleague. After completing it I sent it by email to a friend in a different country for review. Minutes later he called me, astonished to let me know he was the original author of the template five years earlier...

Do SOPs/QMs have to be written from scratch for each company? Don't see why they should so long you are given permission.
 
#10
Hi folks,
I worked hard since 1997 to create the product tech files I have today. Now everyone who is now getting their CE thinks I have to hand them over! Even certain NB suggest our customers obtain copies from us.
Can someone tell me why our competitors shoud have my documents to copy from? The confidential information is not in "part A" but I have still put a lot of work in it.
We have Class IIa dental devices, nothing high level but this "ticks" me off. Anyone have anything to share about this? Is there any other type of document I can send them?
Thanks!
Hello Medic61. Several 'OBL's' seem to think they are entitled to this documentation and fail to realise that they are in fact ultimately responsible for this themselves. The copy and paste culture that is emerging is completely wrong and very irresponsible.

You can send them a brochure and anything else you wish to help them with, because they are customers, but you are right and need to draw the line somewhere. :applause:
 
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