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Products | UK Regulatory Outlook November 2022

European Union, United Kingdom - November 29 2022 From 1 January 2023, businesses were being asked to use the UKCA marking instead of the CE mark, but the government has announced this month that…

Veronica Webster Celda, Anna Lundy, Thomas Stables, Katie Vickery

UK lays out roadmap for regulation of software and AI as medical devices

United Kingdom - October 28 2022 The Medicines and Healthcare products Regulatory Agency (MHRA) has published its "roadmap" for regulating software as a medical device (SaMD) and…

Anna Lundy, Marcus Vass

Products | UK regulatory outlook October 2022

European Union, United Kingdom - October 26 2022 On 28 September, the European Commission announced the adoption of two new proposals to adapt new liability rules for products and artificial…

Veronica Webster Celda, Anna Lundy, Thomas Stables, Katie Vickery

MHRA moves to assuage medical device manufacturers over UK's post-Brexit plans

European Union, United Kingdom - October 26 2022 Medical device manufacturers placing products on the market in Great Britain face a range of regulatory challenges, including the advent of the new…

Stefaine Lo, Anna Lundy

Products | Regulatory Outlook September 2022

European Union, United Kingdom - September 27 2022 On 15 September, the European Commission adopted a proposal for a new Cyber Resilience Act. The Act will introduce cyber security requirements for…

Veronica Webster Celda, Anna Lundy, Thomas Stables, Katie Vickery