Posts with tag Medical Devices

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AI as a Medical Device
To add to all the chatter about AI, let's talk about AI as a medical device. Last month, the Medicines & Healthcare products Regulatory Agency ("MHRA") published guidance on "Software and Artificial Intelligence (AI) as a Medical Device". It didn't necessarily provide for any new regulatory approach to AI in the therapeutic space, but it brought together some important material during this period of increasing interest in AI to effectively remind software...
May 22, 2023
3 min read
Proposed updates to the regulation of medical devi...
While it might be challenging for manufacturers of medical devices...
May 10, 2023
3 min read
The Impact of the NIS2 Directive and the CER Directive...
The rise in the volume of cyber incidents, the war in Ukraine,...
February 17, 2023
9 min read
Update on the UK’s future medical device regulations:...
The UK’s Medicines & Healthcare products Regulatory Agency...
October 31, 2022
2 min read
The Activation of Payback on Medical Devices
The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure...
October 7, 2022
1 min read
UK medical devices regime set for an upgrade
Just 7 months after the expiry of the Brexit transition period, the Medicines and Healthcare products...
October 7, 2021
4 min read
Worldwide Interpol operation Pangea XIV leads to shutdowns and arrests
Operation Pangea is a yearly recurring operation in which Interpol aims to remove the online sale of...
June 24, 2021
2 min read
Impact of Brexit on Artificial Intelligence in Healthcare
AI developments in the UK The UK is starting to uncover significant opportunities...
February 5, 2021
5 min read
Post-Transition Brexit: New MHRA Guidelines on Medical Devices
With a post-transition Brexit looming on the horizon, the Medicines and Healthcare products Regulatory...
September 21, 2020
4 min read
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