LS&HC Horizons 2023 - Flipbook - Page 63
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Europe
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Developments in UK life sciences and health care regulation in 2023
2023 is shaping up to be an active year for
UK life sciences and health care regulation,
with the anticipated publication of major
legislation and government guidance that will
provide more clarity on the UK’s post-Brexit
regulatory landscape. Note that EU regulatory
requirements continue to apply in Northern
Ireland post-Brexit.
Three developments to look out for in 2023 are:
1. Consultation response on UK clinical
trials legislation
The UK Medicines and Healthcare products
Regulatory Agency (MHRA) consulted on
proposals to strengthen UK clinical trials
legislation in 2022. Publication of the
consultation response is expected in the first
half of 2023 and will indicate the direction of
the future UK legislation including the extent
of the overlap with and divergence from the
EU’s Clinical Trials Regulation.
2. Updated medical device legislation
Publication of the updated regime to
replace the current UK Medical Devices
Regulations 2002 was planned for 2022
and subsequently pushed back until Spring
2023. The new legislation is anticipated to
Jane Summerfield
Partner, London
come into effect from 1 July 2024, subject
to various transitional arrangements.
It is expected to align closely with the
requirements of the EU Medical Devices
Regulation (MDR) and EU In Vitro
Diagnostic Medical Devices Regulation
(IVDR) but diverge in some respects
including an abridged assessment process
based on approvals from other countries.
For more on the anticipated content, see our
previous articles here and here.
3. MHRA’s software as a medical device
(SaMD) and AI as a medical device
(AIMD) guidance
In late 2022, the MHRA published a
“Roadmap” for its Software and Artificial
Intelligence (AI) as a Medical Device Change
Program, which is intended to clarify the
application of medical device regulatory
requirements to software and AI devices.
Publication of the first tranche of guidance,
focusing on post-market surveillance,
AI rigor and AI adaptivity, is expected
in early 2023.
Bonella Ramsay
Counsel, London
Bea Watts
Associate, London
Alexandra Wood
Associate, London
