Well said mate.It would appear we have all bases covered for the...

Well said mate.

It would appear we have all bases covered for the Class IIa "device" (ie. Safety + Efficacy)

IMO paediatric device approval means we are a shoe-in for Adult device approval (the PPA/NPA numbers for Adult trial were better).

And remember Europe has a larger Telehealth market than the USA.

Whilst CE is recognised in the 28 EU Member States and European free Trade Association (EFTA) countries, it it can also facilitate penetrating other markets by qualifying for a Certificate of Free Sales (CFS). This document guarantees the manufacturer and device alike meet the various health and safety requirements outlined in the CE marking process.

According to https://www.emergobyul.com/services/worldwide/certificate-free-sale a CFS document can allow a medical device to be sold into the following countries:

Argentina, Australia, Bolivia, Brazil, Chile, China, Colombia, Costa, Rica, Ecuador, Egypt, India, Iraq, Israel, Japan, Jordan, Lebanon, Mexico, Oman, Peru, Qatar, Russia, Saudi, Arabia, South Korea, Sri Lanka, Syria, Taiwan, Thailand, United, Arab, Emirates.

So...the CE Mark approval is a big, BIG deal....and we are almost there.

RAP will be a beast, have patience.