Ann: Appendix 4D and Half Year Financial Report, page-20

Fda Shutdown delays add very little only a couple of weeks.
Probably only catch the tail end as the application is not submitted yet.

At time of shutdown 41% of workers not working.
More to do with recalls and inspections
No new 510k and other app reviews till restart and funding is back.


Ce from Brexit delays?

Medical devices after brexit will continue to adhere to the ce mark (recognise it)
for now. draft legislation being hashed out still. no provisions on the UKCA mark.
So for now smooth sailing for CE mark medical devices.
Most products appear to need a seperate UK mark  while
construction products, medical devices and rail interoperability dealt seperately.
Nothing 100% till new legislation
Some mention of transition period as well.


Not investment advice, do your own research, and consult a licensed adviser