Bunny

Quite Involved in Discussions
#1
We are the medical device manufacturer, our sales channel is a larger medical device manufacturer. We are selling our class I medical devices to them and they are placing them on the EU market. They have not asked us to perform any translation services of our GUI or user manual. I recently questioned this and now we are trying to meet the requirements. Are we obliged to perform the translations, update the GUI and manuals and sign the DOC or is it the responsiblity of the organization placing the product on the market?
 

somashekar

Super Moderator
Staff member
Super Moderator
#2
We are the medical device manufacturer, our sales channel is a larger medical device manufacturer. We are selling our class I medical devices to them and they are placing them on the EU market. They have not asked us to perform any translation services of our GUI or user manual. I recently questioned this and now we are trying to meet the requirements. Are we obliged to perform the translations, update the GUI and manuals and sign the DOC or is it the responsiblity of the organization placing the product on the market?
It is the responsibility of the legal manufacturer, as appearing on the device label alongside the factory symbol.
 

MIREGMGR

Inactive Registered Visitor
#3
"Placing on the market" should be definitive, and maybe it is.

Do you and they agree, perhaps in your business agreement or in the POs that they send to you and you acknowledge, that they are regulatorily responsible for the product? Or, do they see themselves as a distributor?

Is the CE Mark placed on the product label by your determination and per your CE certificate, or at their direction and per their CE certificate? Who is stated on the product label as the Manufacturer? Who maintains the tech file?
 

Bunny

Quite Involved in Discussions
#4
I am not sure what the agreement says.

We place the CE Mark on the product.

We are listed as the Manufacturer.

We maintain the tech file.

I guess that it is up to us then.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
We are the medical device manufacturer, our sales channel is a larger medical device manufacturer. We are selling our class I medical devices to them and they are placing them on the EU market. They have not asked us to perform any translation services of our GUI or user manual. I recently questioned this and now we are trying to meet the requirements. Are we obliged to perform the translations, update the GUI and manuals and sign the DOC or is it the responsiblity of the organization placing the product on the market?
When I was making CE marked components for use in medical devices and O2 systems it was up to us to offer translation of our User Instructions but we didn't automatically provide it and the end users rarely requested it.

best thing to do is consult with your Notified Body.
 

somashekar

Super Moderator
Staff member
Super Moderator
#6
I am not sure what the agreement says.

We place the CE Mark on the product.

We are listed as the Manufacturer.

We maintain the tech file.

I guess that it is up to us then.
As a part of your technical file, do you not have a procedure for determination of language requirements ?
Somewhere you would have made a commitment to the NB that you will determine and implement the language requirements as and when your devices are getting ready to be placed in any specific EU member country.
 

SilkTie

Involved In Discussions
#7
[..]
best thing to do is consult with your Notified Body.
Not only that, beware of the stickler auditor who prefers the translations performed by an NB approved translator, if possible, and all translations validated, either by the manufacturer or the customer.

I had it with IV pumps where the NB 'adviced' us to use an approved translator and required the translations to be validated by a doctor in the target market. The 'advice' we left for what it was, the validations we filed diligently.
 
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