RE: MHRA approved RNS8 Apr 2021 09:10
'Changes in the applicable legislation on 1 January 2021 mean that from 1 January 2022, all Class 1 medical devices, which includes the Pro Larva mask, will need to be registered with the MHRA.'
It's a continuation of existing certification due to a change in protocol. Fantastic they passed it but this isn't as exciting as some are making out. If my assumptions are wrong please say so..