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Mandatory Medical Device Problem Reporting Form for Industry 2018-2025

2018-2025 Form

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hi there and welcome to the gcp mindset channel i'm carol this is our part two of the video of safety monitoring this time on medical device studies when running clinical investigations on medical devices safety of the patients is a priority and a requirement for regulations in this video we'll go over the responsibilities of a sponsor and the investigator in safety reporting in the eu for medical devices not bearing the ce mark or those with ce mark but tested outside of the intended purpose in a clinical investigation [Music] since the eu medical device regulation the mdr came into place on 26th of may this year safety reporting for medical devices within clinical investigations is required to be in line with the requirements of the mdr this is supposed to be done now via the utermed web form once it will be available and fully functional until then the summary tabular format that's the summary safety reporting form still needs to be used in ance with the guid

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