jonherries: To be clear, these regulations from 2003 (not 2013) aren't very useful because they don't provide useful descriptions of what a medical device is, particularly in the context of software and more interestingly 3D bio-printing and genomics (like Car-T Cell therapy), this is a fundamental issue and a large part of the reason for developing new legislation. You can read more here about some of these issues here (there are more issues than are listed here):
This is also useful to read in this context (the definition of what a medical device is according to the regulations):
Secondly and maybe more importantly, which it appears Apple and @BlinkyBill have failed to realise is this is a registration only, not an approval.
Thanks; sorry about the typo.
it’s interesting ... I had thought, I guess assumed, that medical devices needed to be approved for use. Given the possible negative affects of over-medicalising a medical event, a possible AFib, to me it makes sense that a medical device should only be used when it is shown to me medically safe and medically useful, which are two different things.
I’m going to start selling my Robodoc2000 immediately - no need for trials or evidence that it works.
I’m having breakfast with Bloomers in a couple of weeks - it’ll be interesting to see what he says.