Essentials of European Medical Device Regulatory Affairs - October 2019

October 2019

Essentials of European Medical Device Regulatory Affairs

Janis Bayley

Eli Lilly and Company

Jane Arnold-Round NAMSA

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

Agenda • Housekeeping

• What is a Device? • Who’s who – Key Stakeholders • Legislation • Classification of Devices • Conformity Assessment • Device Labelling • Clinical Evaluations • Post Market Requirements

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