US Made class I CE Mark product for export only to EU

[divinagati2]

Are there FDA regulations to comply with?

 

[Marcelo]

Hello, and welcome to the Cove!

Please see Exporting Unapproved Devices.

 

[divinagati2]

Thanks, Marcelo. That helps. We are new to CE Marking and I hope you don't mind assisting me with two more questions. (1) Since our product is CE IVD, do we need to register our company as an exporter to FDA even if we are not seeking for FDA approval in the US?, and (2) Can we still release a Declaration of Conformity under the Directive 98/79/EC although IVDR 476 is already in place?

 

[Marcelo]

(1) Since our product is CE IVD, do we need to register our company as an exporter to FDA even if we are not seeking for FDA approval in the US?

Yes, this is written in the second paragraph of the link I sent you:

U.S. manufacturers that export medical devices outside the U.S. are required to register their facility and list their devices even if the devices are not distributed in the U.S. (21 CFR 807).

(2) Can we still release a Declaration of Conformity under the Directive 98/79/EC although IVDR 476 is already in place?

Yes. IVDR entry into force was 25 May 2017, but the date of application is 26 May 2022.

 

[divinagati2]

Thank you for your help!