medicines-medical devices-regulatory affairs
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 Advice (SNSA) from the National Competent Authorities (NCAs) in February 2020. The pilot was extended to the end…
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…
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…
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…
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…
The TGA, Australia has published a checklist for manufactures of medical devices to demonstrate compliance with the essential principles for their medical devices. TGA states that it is the manufacturer’s responsibility to demonstrate compliance with the essential principles for their…