Early clinical investigations of new high-risk medical devices – how lack of transparency inhibits improvement in evaluation

Programme 

(CET time zone)

17:00 - 17:05              Introduction by Moderator

                                    Prof. Alan Fraser, Cardiff University, CORE-MD Scientific Coordinator

17:05 – 17:15             The CORE-MD study of introducing novel methodology for clinical evidence development

                                   Prof. Peter McCulloch, University of Oxford.

17:15 – 17:25             Manufacturer’s challenges in implementing the MDR

                                    Prof. Mark Slack, co-founder and the Chief Medical Officer of CMR  Surgical

17:25 – 17:35             Patients perspective on clinical evidence for high-risk medical devices
                                    Ms Claudia Louati, Head of Policy, European Patient’s Forum

17:35-17:45                Discussant  

                                   Dr Gearóid McGauran, MD, MSc, CIE Working Group of the Medical Device Coordination Group, Health Products Regulatory Authority, Ireland

17:45 – 18:15             Questions and Answers with the audience

Learning objectives:

• Understand the challenges of early clinical investigation in the context of the medical device regulation.
• Receive viewpoints and perspectives from Patients, Manufacturers and Regulators.
• Explore possible solutions stemming from CORE-MD recommendation.

View the poster 

Please register via this link: https://zoom.us/webinar/register/WN_am1i-F0OTnO8Ctr-5Nn1dQ