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.
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
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 ?
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
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