Register today for the upcoming CORE-MD Webinar on “Pivotal Clinical Investigations of High-Risk Medical Devices: “What Guidance Do We Need and by Whom?“ taking place on Monday 27 November 2023 from 17:00 to 18:15 CET.

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 Group and its role in the European Medical Device Regulatory 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.
subscribe to our newsletter