![MHRA Roadmap on SaMD Change Programme: AIaMD](https://www.regdesk.co/wp-content/uploads/2023/05/MHRA-on-SaMD-regulation-improvement-AIaMD1.png)
May 24, 2023
Europe
The new article addresses the matters related to the regulatory status of the products based on artificial intelligence technology, regulated as medical devices. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), a UK authority in the...
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![MHRA Roadmap on Software/AI Framework Improvement: Cybersecurity](https://www.regdesk.co/wp-content/uploads/2023/05/surgeon-with-arms-crossed-standing-near-ultrasonic-device-machine-1080x675.jpg)
May 1, 2023
Europe
The new article highlights the aspects related to cybersecurity for software-based medical devices intended to be marketed and used in the UK. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), a UK regulating authority in the sphere of...
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![MHRA Roadmap on Software and AI as a Medical Device Change Program: Post Market](https://www.regdesk.co/wp-content/uploads/2023/04/young-bearded-doctor-with-both-hands-keyboard-typing-recipe-patient-doctor-concentrating-his-work-clinic-1080x675.jpg)
Apr 10, 2023
Europe
The new article highlights the aspects related to post market activities intended to ensure continuous safety and proper performance of medical devices allowed to be marketed and used in the country. Table of Contents The Medicines and Healthcare Products Regulatory...
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![MHRA Roadmap on Software and AI as a Medical Device Change Programme: Premarket Requirements](https://www.regdesk.co/wp-content/uploads/2023/03/hand-medical-glove-pointing-virtual-screen-medical-technology-1080x675.jpg)
Mar 23, 2023
Europe
The new article describes in detail the aspects related to the existing premarket requirements and the improvement they require. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare...
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![MHRA Roadmap on SaMD Regulatory Improvement: Classification](https://www.regdesk.co/wp-content/uploads/2023/03/scientist-coverall-suit-with-coronavirus-sample-british-flag-1080x675.jpg)
Mar 2, 2023
Europe
The new article highlights the aspects related to the classification of medical devices the UK authority intends to improve by the virtue of amending the existing regulatory framework. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA),...
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![MHRA Guidance on SaMD: Qualification and Concepts](https://www.regdesk.co/wp-content/uploads/2023/01/pexels-david-peterson-344775-1080x675.jpg)
Jan 23, 2023
Europe
The article highlights the key points related to the qualification of medical devices for the purpose of determination of their regulatory status, and also provides additional details regarding the most important concepts used. Table of Contents The UK Medicines &...
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