Tune into the second episode of Covington’s Life Sciences Audiocast, where Sarah Cowlishaw, Ellie Handy, and Léna Beley discuss key developments in the medical device sector in the EU and the UK. Our speakers review the major legal developments for medical devices in the last few years, including the issues surrounding the entry into force of the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation and the proposed measures to address them, the implications of the EU’s proposed Artificial Intelligence (“AI”) Act for software medical devices, and the effects of Brexit on the regulation of medical devices in the UK.
Our experts present the current state of play in the EU and the UK, and how these developments are expected to shape the coming years for medical devices.
Please note that since the date of recording this podcast, an agreement in principle has been reached by the UK and EU relating to post-Brexit trade issues in Northern Ireland. This agreement in principle is being referred to as the “Windsor Framework”. Unlike the position for medicines, the Windsor Framework does not include any changes to the regulatory arrangements for placing medical devices on the market in Northern Ireland.