Hey everyone.
I am currently in the process of closing an agreement with an EU Rep. since I am marketing some products outside of Europe and thus, I need an EAR.
Could you please inform me if a class Ia medical device product, needs to be audited (class I=self-declaration)? Or am I only required to have the technical files for it reviewed and approved by my European Authorized Representative?
Thank you in advance for your time and help!
I am currently in the process of closing an agreement with an EU Rep. since I am marketing some products outside of Europe and thus, I need an EAR.
Could you please inform me if a class Ia medical device product, needs to be audited (class I=self-declaration)? Or am I only required to have the technical files for it reviewed and approved by my European Authorized Representative?
Thank you in advance for your time and help!