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PRODID:-//YourOrganization//EventDownload//DE
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UID:69e4b9d369ecf@leapup.bitshifters.cloud
DTSTAMP:20260419T131739Z
DTSTART:20250209T090000Z
DTEND:20250209T151500Z
SUMMARY:Approval of software as medical device in Europe: Overview of the requirements and insights from practice
DESCRIPTION:Manufacturers of software with a medical intended purpose are subject to many laws and other regulations in Europe. These are primarily the Medical Device Regulation (MDR) and the In-vitro Diagnostic Medical Devices Regulation (IVDR). Manufacturers must also comply with the relevant guidelines and technical standards. In addition\, there are requirements from horizontal EU legislation such as the Artificial Intelligence Act (AIA) or the existing General Data Protection Regulation (GDPR) as well as from national legislation such as the Medical Devices Implementation Act (MPDG) in Germany. 
LOCATION:MS Teams\, Offenbach am Main
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