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Current regulatory requirements for medical apps Presentation at the medical.device.forum of TÜV SÜD

This year's medical.device.forum of TÜV SÜD will take place on 01./02.12.2020. Dr. Gerrit Hötzel will report on "Current regulatory requirements for medical apps" on 02.12.2020. The topics in detail:

  • Digital Healthcare Act, digital health apps and initial experiences

  • The "new MEDDEVs": MDCG document 2019-11 on the classification and categorization of medical apps

  • Regulatory requirements of the GDPR, telemedicine and IT security, requirements of the data protection supervisory authorities

  • Examples of previous fails and best practices as well as an example of a "networked app" digitalization project

  • Know-how protection for medical device manufacturers

  • New EU manufacturer requirements for long-term software updates

Registration is possible via the TÜV SÜD website.

Please also note our current brochure Potentials MedTech 2021 on the topic of MedTech.