Buying and selling Class I and II medical devices

JoCam

JoCam

Trusted Information Resource
#1
#1
Hi All,

I work for a medical device manufacturer in the UK. If we were to purchase Class I and II medical devices manufactured by an American manufacturer to sell in Europe (under the manufacturers name not ours), what documentation would we need to obtain from the OEM?

Regards,

Jo
 
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Ronen E

Ronen E

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#2
#2
Hi,

As a start, for class I non-sterile and non-measuring devices you need a record of notification to (registration with) an EU competent authority, and for higher-classification devices you need the EC certificate issued by a NB. The devices' labelling should show the EC rep details and of course the CE Mark.

Cheers,
Ronen.
 
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