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

[Bridget]

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]

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]

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).