Experience with Notified Body - ITC from Czech Republic for Medical Devices

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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Re: Experience with Notified Body- ITC from Czech Republic for medical devices

I can't help, but you might want to be more specific about what you want to know about ITC.
 

DannyK

Trusted Information Resource
#5
Re: Experience with Notified Body- ITC from Czech Republic for medical devices

I can't help, but you might want to be more specific about what you want to know about ITC.
I am having a difficult time getting responses from their technical reviewers.
I wanted to know if there are others who are having the same or different difficulties.
 

pkost

Trusted Information Resource
#6
Re: Experience with Notified Body- ITC from Czech Republic for medical devices

All Notified bodies are reviewed and approved to the same standard ;)

In reality, I would avoid eastern block notified bodies as there is in some cases evidence of poor performance and generally a belief that they are not as good

That being said, in their defense, I am generally finding all notified bodies to be slow and unresponsive at the moment
 

DannyK

Trusted Information Resource
#7
Re: Experience with Notified Body- ITC from Czech Republic for medical devices

It seems odd that there are notified bodies that do not respond to emails and it is difficult for a company to make plans to sell in the EU.
Is there any organization that we can complain to since the NB is not providing the service noted in the contract ?
 

somashekar

Staff member
Super Moderator
#8
Re: Experience with Notified Body- ITC from Czech Republic for medical devices

Hi Danny..
ITC does not seem to have Canada office.
So I guess your contact is direct.
Is this correct, or is there a Canada liaison office of ITC ?
 

pkost

Trusted Information Resource
#9
Re: Experience with Notified Body- ITC from Czech Republic for medical devices

You can of course sue them for breach of contract. Or if they are failing in their responsibilities as a notified body you could complain to the competent authority, but note their responsibilities to the competent authority are different from their obligations to you! A competent authority won't care that you are unable to get a response from them
 

DannyK

Trusted Information Resource
#10
Re: Experience with Notified Body- ITC from Czech Republic for medical devices

Hi Danny..
ITC does not seem to have Canada office.
So I guess your contact is direct.
Is this correct, or is there a Canada liaison office of ITC ?
We deal with the person at the Czech office. There is no Canadian office to contact.
 
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