The EU Reg. 2017/745 on Medical device regulation (Mdr): challenges and opportunities

The Medical device regulation (Regulation (EU) 2017/745, Mdr) will become applicable on 26 May 2021. It aims to improve patient safety by strengthening the procedures for conformity assessment and post-marketing surveillance. The MDR is expected to impact both the market for medical devices and national health systems (NHSs). As regards the former, many eHealth applications fall under the scope of the MDR. Since they process personal data, including health data, such applications are also subject to data protection law. As regards NHSs, the MDR is expected to impact public governance for medical devices. 

Agenda:

14.00 – 14.10 ETHOS and the new frontiers of R&D&I, Denise Amram, Scuola Superiore Sant’Anna

14.10 – 14.25 The new Medical Device Regulation: Compliance Pills, Andrea Parziale, Scuola Superiore Sant’Anna

14.25 – 14.40 The Medical Device Regulation and the GDPR in the Development of eHealth Apps, Giulia Schneider, Scuola Superiore Sant’Anna

14.40 – 14.55 The Medical Device Regulation: a New NHS Governance Model for Medical Devices?, Mirko Claus MD, Università di Padova

14.55 – 15.05 Future Challenges for R&D&I Giovanni Comandé, Scuola Superiore Sant’Anna

15.05 – 15.15 Discussion (Q&A)

Registration is reccomended: segrliderlab@santannapisa.it

Join the Webinar https://sssup.webex.com/sssup/onstage/g.php?MTID=e6a39370a6c16e340ba1cc822b2ea8ead