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

DannyK

Trusted Information Resource
Hello,

Please share your experience with ITC, Notified body 1023 from the Czech Republic for medical devices.

Thank you,

Danny
 

Marc

Fully vaccinated are you?
Leader
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
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
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
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

Leader
Admin
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
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
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.
 
Top Bottom