• Psephos

Software/AI Medical Device EU MDR CE Marking Workshop


This one day workshop was run by SEHTA and Psephos Biomedica on 24th April 2019


There has been an explosion of new digital health technologies such as mobile health apps and artificial intelligence (AI) and software Medical Devices. To sell software and AI as a medical device in the UK and Europe it must have the CE mark. The EU Medical Device Regulation (MDR) is in its implementation phase and will be fully effective from May 2020. All medical devices including new digital health technologies will need to comply with these new Regulations.


This one-day event provided an overview of the:


Software/AI medical device CE Marking Process, Software Device Classification and Conformity Assessment, Technical File, Quality Management & Post Market Surveillance & Vigilance and the opportunity to hear from your peers.


Outcomes:

  • Gain an overview of the new EU Medical Device CE marking Process for software

  • Understand the key areas of compliance required

  • Understand the technical documentation that should be in place for each device

  • Key pointers for next steps

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