UK market access, handled.
UK medical device regulatory support for software-based products — MHRA requirements, device registration where applicable, and a plan that holds as the UK framework continues to change.
What we do for UK-bound programmes.
A pragmatic view of what the UK actually requires today, and what you should be building towards.
UK medical device regulatory requirements
Establishing which requirements apply to your product, including software-specific expectations.
MHRA requirements
Understanding and meeting MHRA obligations, including UK Responsible Person arrangements where relevant.
UK market access strategy
Sequencing UK access alongside your EU or US plans so evidence is reused rather than rebuilt.
Registration support where applicable
Preparing and supporting MHRA device registration — the one place where 'registration' is the correct term.
Preparing for evolving requirements
Planning for the UKCA transition and the future UK regulatory framework without over-building now.
UK device registration with the MHRA is a genuine registration step — but it is not a conformity assessment and it does not, by itself, demonstrate compliance. Knowing which obligations are administrative and which are evidential is what keeps UK programmes proportionate.
Bringing a product to the UK?
We'll set out what applies now, what is changing and what your evidence set needs to cover.