LS&HC Horizons 2022 - Flipbook - Page 63
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
63
Europe
Proposed reform of UK medical devices regulation
The UK Government is proposing to reform existing UK medical
devices legislation with effect from 1 July 2023. Currently, UK medical
devices legislation continues to be based on previous EU legislation.
At a high level, the reform is intended to further protect patients and
to support the UK as an attractive market to develop, produce and
supply medical devices.
As one of the first reforms of industry-sector level legislation
post-Brexit, the UK Government is seeking both to minimise the
regulatory burden on business by aligning with EU and international
requirements, while also using its increased legislative flexibility
to navigate some of the challenges of those requirements, create a
flexible and proportionate regulatory system, and focus on innovation.
The proposed changes include:
• Bringing UK legislation into closer alignment with the new EU
Medical Devices Regulation (EU MDR) and In-Vitro Diagnostic
Medical Devices Regulation (IVDR), as well as with international
standards;
• Increased collaboration with international regulators, including a
fast-track access pathway that would enable medical devices to be
approved in the UK based on approval in other trusted markets
such as the US and Canada;
• A specific framework for regulating software and artificial
intelligence solutions as medical devices;
• Introducing new measures such as impact assessments to support
sustainable manufacturing and improve supply chain resilience.
The Medicines and Healthcare products Regulatory Agency (MHRA)
consulted on the initial proposals at the end of 2021 and draft
amending legislation is in development.
Jane Summerfield
Partner, London
Bonella Ramsay
Counsel, London
Alexandra Wood
Associate, London
