Medical Device registration

Cayde-6

Registered
We deliver our products in a specific country, but our client export our product to another country(for example, we deliver in a European country but our client exports it to UK) in this situation are we responsible? Do we need to register the product even if we don’t deliver the product in the final country ?
 

Alan_DB

Involved In Discussions
All devices in sold in the UK must be registered with the MHRA. If the manufacturer is located outside the UK then they need a UK Rep. Similar to having an EU rep if outside the EU.

I presume your client in the EU is a distributor?
 

Cayde-6

Registered
All devices in sold in the UK must be registered with the MHRA. If the manufacturer is located outside the UK then they need a UK Rep. Similar to having an EU rep if outside the EU.

I presume your client in the EU is a distributor?
Yes. The client is a distributor. I understand the product needs to be registered with MHRA. It’s just that who is responsible the distributor or the manufacturer?
 
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