Announcements

The MHRA has published a new work programme for software as a medical device (including on artificial intelligence), alongside its much anticipated public consultation inviting proposals from industry participants. This comes as part of a broader movement of innovation in UK healthcare regulation post-Brexit and provide a great opportunity to both shape and clarify the future regulatory requirements for medical software. Read an article reporting on the two significant updates here: https://www.sidley.com/en/insights/newsupdates/2021/09/digital-health-in-the-uk-mhra-bold-new-regulatory-world

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https://www.gov.uk/government/publications/software-and-ai-as-a-medical-device-change-programme/software-and-ai-as-a-medical-device-change-programme

https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom

https://www.sidley.com/en/insights/newsupdates/2021/09/digital-health-in-the-uk-mhra-bold-new-regulatory-world