Essentials of European Medical Device Regulatory Affairs

July 2019

Essentials of European Medical Device Regulatory Affairs

Janis Bayley Eli Lilly and Company Theresa Jeary SFL Regulatory Affairs

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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