What is sufficient clinical data ?


We are glad to host the ECLEVAR International Conference about clinical requirement under MDR, which will be organized in Paris. This conference will focus on several topics about the introduction of EU MDR and its impact on clinical evaluation, premarket clinical trials and post market clinical follow-up.
Several speakers from notified bodies to medical device companies will discuss the upcoming changes in Medical Device areas.

This one day conference topics will include :
– What is sufficient clinical data?, Matthias Fink, TÜV SÜD
– IVDR, the challenge of clinical evidence requirements, Andreas Stange, TÜV SÜD
– Real World Data and Clinical Data Solution, Alexandre Templier and Frederic Couriol, ECLEVAR
– Industry perspective on MDR implementation, Henk Snyman, COOK MEDICAL
– Digital Clinical Data, Tobias Schreiegg, SIEMENS HEALTHINEERS
– Clinical Evaluation Report, Dona Occhipinti, HILLROM
– Automated Clinical Evaluation Report, Chems Hachani and Sébastien Tourlet, ECLEVAR


Andreas Stange

Vice President, TÜV SÜD

Matthias Fink

Clinical Reviewer, Clinical Centre of Excellence, TÜV SÜD

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Chems Hachani

CEO & Chairman, ECLEVAR

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Henk Snyman

Director Regulatory Affairs, COOK MEDICAL

Dona Occhipinti

Medical Affairs EU MDR Project Manager, BECTON DICKINSON

Alexandre Templier

Lead Human Data Science, ECLEVAR

Sébastien Tourlet

Director Strategic Innovation, ECLEVAR

Frederic SITE

Frederic Couriol

Senior Director, Real World Data Science, ECLEVAR

contact :

00 33 1 45 01 61 60