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Can Class IIa Dental Medical Devices be sold into the EU without CE

#1
a manufacturer of Class IIa devices (Dental) wants to know if any products can be purchased by companies in the EU without a CE mark. A quality system is in place but the NB states at least 6 months of compliance with ISO 13485 is required before they will audit this company.

Can companies in the EU purchase devices if they have the CE and a technical file for the device?
Thanks!
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
a manufacturer of Class IIa devices (Dental) wants to know if any products can be purchased by companies in the EU without a CE mark. A quality system is in place but the NB states at least 6 months of compliance with ISO 13485 is required before they will audit this company.

Can companies in the EU purchase devices if they have the CE and a technical file for the device?
Thanks!
Not sure I understood the question (because you are in the US).

You want to know if a company from outside Europe can buy a product without CE marking, or a company inside EU can buy a product without CE Marking?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#3
Oh, just noted the thread title, so you want to know if a company in the EU can buy a product without CE Marking.

They can buy it, but it cannot be put into the market (it cannot even enter the EU, in fact).
 


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