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This is a rather specific situation and I would like to propose the call. But before that, I advise you to go through these guidelines published by EU Commission:
Is your software a medical device - https://ec.europa.eu/health/system/files/2021-03/md_mdcg_2021_mdsw_en_0.pdf MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR - https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdf
I believe that you will find your answers here. If not, let me know and we will arrange a meeting.
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Jan 21, 2022