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Session 5: Transparency Implications of the EU Medical Device Regulations (MDR)
Session Chair(s)
Matthias Zerm, PhD
Lead Expert, Clinical Trial Disclosure and R&D Processes
Germany
The EU Medical Device Regulation (Regulation (EU) 2017/745) in conjunction with the upcoming new version of EN ISO 14155 introduces many new clinical trial disclosure and transparency requirements relating to clinical investigations with medical devices in the EU as from May 2020. The clinical module in Eudamed will serve as the central system for submitting, exchange of information, and reporting of clinical investigations and will be accessible to Regulatory Authorities, notified bodies, industry, and the public. Objectives: • Gain first hand insights on how information/documents relating to clinical investigations will be made publicly available in Eudamed: • What information/documents? • Publicly available at what point in time over the course of a clinical investigation? • What criteria and measures are foreseen to ensure protection of personal data and commercially confidential information potentially contained therein? • Learn about the new public disclosure provisions in the upcoming new version of EN ISO 14155:2018 and how they relate to the MDR and may become applicable beyond.
Speaker(s)
Industry View: Disclosure of clinical investigation information in Eudamed – what, when, how?”
Celine Bourguignon, PharmD
GSK, Belgium
Head Greater China and Intercontinental & Emerging Markets Regulatory Policy
New Version of ISO14155:2018
Danielle Giroud
World Medical Device Organization, Switzerland
Founder
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