New report from the National Institute for Public Health and the Environment – RIVM from the Netherlands – Apps under the medical devices legislation
RIVM – Apps under the medical devices legislation
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- Australia – TGA – Actual and potential harm caused by medical software
- EU – MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
- Australia – New TGA Classification Rules for Software that is a Medical Device – IMPORTANT DATES
- TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD)
- EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
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