Thank you, Mike.
Meanwhile, perhaps one of the Gurus
at Eastwood Park might like to review it (and update where necessary).
Presumably their students are given the latest information?
In case any lingering doubts remain, the MHRA document "Managing Medical Devices
" (Apr 2015) provides the current official guidance in the UK.
See also Legislation ...
... which also contains some links that no longer work.
That's the trouble with placing links in documents; keeping them up to date becomes a full time job!