Additional National requirements for placing MD in the EU countries

[iparlatore]

Hello to all,

I am trying to find information about additional requirements for placing MD in the EU on top of CE marking. For example, I know in Italy there is the Repertorio when MD must be listed. I believe also Germany and France have something similar. Can anybody advice a good way of finding this info?

Thanks,

IP

 

[shimonv]

The national requirements are mostly about language and listing requirements, and they are published in the local languge.
It would be best to consult your EU Rep. It simply isn't worth your time to figure these out by yourself.


Shimon

 

[iparlatore]

Thank you Shimon. I am doing this work for a small start up who is starting now to place product in the EU. They are based in Italy so they don't have a EU rep.

 

[shimonv]

Well, second best option is to talk to potential distributors when the company begins to scale up.

 

[iparlatore]

Sure, that's good advice. Thanks

 

[Chrisx]

I received the following from our EU AR.

 

[iparlatore]

Thank you so much Chrisx, the document you share is very helpful!

 

[Philip B]

I normally email the Competent Authority in the applicable country and have always found them to be helpful.