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AEMPS launches an accelerated evaluation procedure for clinical trials

AEMPS has launched an accelerated evaluation procedure or fast-track with the aim of making Spain a more attractive environment for research into innovative medicines. In general terms, Regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use establishes the maximum deadlines for…

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EU launches Phase 2 of the Simultaneous National Scientific Advice (SNSA) pilot

Last updated: 26 April 2024 To see updates, click on the ‘+’ sign below The EU Innovation Network (EU IN) has launched Phase 2 of the simultaneous national scientific advice (SNSA) pilot. The EU IN started Phase 1 of the pilot for Simultaneous National Scientific…

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UK, US and Canadian regulators identify ten guiding principles to be addressed when medical devices use AI or machine learning software

The UK, US and Canadian regulators have identified ten guiding principles to be addressed when medical devices use Artificial Intelligence (AI) or machine learning software. AI and machine learning technologies have the potential to transform health care by deriving new…

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Swissmedic provides practical interpretation on the requirements of an authorised representative (CH-REP) for drug-device combination products

Last updated: 4 October 2022 See updates at the end of the post. Swissmedic has provided practical interpretation on the requirement of an authorised representative (CH-REP) for drug-device combination products. Swiss authorised representative (CH-REP) The revision of the Medical Devices…

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Lucida Medical’s AI based and CE marked prostate cancer detection software Pi™ to be validated

Lucida Medical’s AI based and CE marked prostate cancer detection software, Prostate Intelligence™ (Pi™) is to undergo a retrospective cohort validation study . In May 2021, Lucida Medical was granted a CE Mark for Prostate Intelligence™ (Pi™ ), its AI-machine…

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TGA publishes guidance for developers and users of software to decide which software and apps are medical devices

The TGA, Australia has published guidance for developers and users of software to decide which software and apps are medical devices. The flowcharts in the guidance document show which software products are regulated as a medical device and which are…

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