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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, Peter Rudd-Clarke, 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…

Peter Rudd-Clarke, 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, Peter Rudd-Clarke, 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, Peter Rudd-Clarke

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, Peter Rudd-Clarke, Thomas Stables, Katie Vickery