Sale medical device to European Hospitals

#1
We are a Non-EU medical device manufacturer which has CE and ISO 13485 certificate. Doctors from UK and Belgium hospital would to use our product ( category IIb) now, but we don’t have any distributors in the Europe.

I would like to know,

1) Could we sale our product from China to EU hospitals directly?
2) If so, is there any specific requirements for hospitals?
 

Access2hc

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#2
It would be wise to inform your EU AR of these plans, as they are ultimately responsible for the product in the EU market. Traceability to the end-users very important, and any appointment of the transportation guys for the product must be known to the AR and qualified.

If need help just check with me

Cheers,
Ee Bin
Access2hc
 

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