The CORE-MD Consortium has organised it’s seventh webinar for Monday 27 of November. The title of this webinar is “Pivotal Clinical Investigations of High-Risk Medical Devices: “What Guidance Do We Need and by Whom?”.
Moderator: Prof. Alan Fraser
The Webinar will address the following topics:
- 17.00 – 17.05 | Introduction by Moderator, Prof. Alan Fraser, BioMed Alliance, Scientific Coordinator of CORE-MD.
- 17.05 – 17.25 | Results of the Review on Recommendations on the Trial Design of Pivotal Clinical Investigations of High-risk Medical Devices – Dr.Petra Schnell-Inderst, MPH, Dipl.-Biol., Institute of Public Health, Medical Decision Making and Health Technology Assessment, UMIT TIROL, Austria.
- 17.25 – 17.40 | What Guidance Do the Notified Bodies need? – Richard Holborow, Head of Clinical Compliance BSI Group.
- 17.40 – 17.55 | Guidance by the CIE Working Groupand its role in the European medical device approval system – Gearóid McGauran, MD, MSc, CIE Working Group of the Medical Device Coordination Group, Health Products Regulatory Authority, Ireland.
- 17.55 – 18.15 | Moderated discussion and Q&A from the audience.
Learning Objectives:
- To become familiar with the existing recommendations on Trial Designs of pivotal clinical investigation for medical devices.
- To explore notified bodies’ needs and expectations, in the context of the implementation of the MDR.
- To understand the role of EU regulators with respect to clinical investigations in the EU.
- To interact with key players in the field of clinical evaluation of high-risk medical devices.
