Hi all,
I am working with a client who has a class II medical device that transmits data via Bluetooth wireless to custom software. They want to get CE marked. Other than the MDD, I believe the RTTE directive also applies. Is this correct? Are the other directives that I may not be aware of? Software guidances for EU?
Thanks!
I am working with a client who has a class II medical device that transmits data via Bluetooth wireless to custom software. They want to get CE marked. Other than the MDD, I believe the RTTE directive also applies. Is this correct? Are the other directives that I may not be aware of? Software guidances for EU?
Thanks!