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Session 5: Medical Devices: Clinical Trial Disclosure Requirements in the EU Medical Device Regulation and in ISO 14155:2020
Session Chair(s)
Matthias Zerm, PHD
Lead Expert, Clinical Trial Disclosure and R&D Processes
Germany
The EU Medical Device Regulation (MDR) (Regulation (EU) 2017/745) and the new version of ISO 14155:2020 introduce many new clinical trial disclosure and transparency requirements relating to clinical investigations with medical devices in the EU and beyond. We will look at the MDR and ISO 14155 requirements and provide an update on the progress of the clinical module in Eudamed which is scheduled to become available in May 2022.
Speaker(s)
EudaMed Updates
Celine Bourguignon, PHARMD, MPHARM, MS
GSK, Belgium
Senior Director Regulatory Policy & Intelligence
ISO 14155 Requirements
Matthias Zerm, PHD
Germany
Lead Expert, Clinical Trial Disclosure and R&D Processes