Overview of European Regulations of Medical Device

C

Caravan

#11
[FONT=&quot]Hi Mike

for the countries you listed there is no real problem, except Italy. Nevertheless, this is only a formality. Your local distri must register himself with the Italien authorities.

Yes, you are right with the Non-EU countries, but most of them already recognizing an EU registration in combination with a CE mark issued by a notified body. This makes it a bit easier.[/FONT]
[FONT=&quot]
[/FONT]
[FONT=&quot]However, keep in mind there is a major change in the EU legislation, as the MDD will be replaced by a new MD regulation.[/FONT]


Regards
J?rgen
 
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Ronen E

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Moderator
#12
[FONT=&quot]Hi Mike

for the countries you listed there is no real problem, except Italy. Nevertheless, this is only a formality. Your local distri must register himself with the Italien authorities.

Yes, you are right with the Non-EU countries, but most of them already recognizing an EU registration in combination with a CE mark issued by a notified body. This makes it a bit easier.[/FONT]
[FONT=&quot]
[/FONT]
[FONT=&quot]However, keep in mind there is a major change in the EU legislation, as the MDD will be replaced by a new MD regulation.[/FONT]


Regards
J?rgen
It's important to note that the change to EC regulations will probably not come into force earlier than 2018-2019.
 
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