Essentials of European Medical Device Regulatory Affairs

February 2018

The Basics of European Medical Device Regulatory Affairs

Janis Bayley Angela Stokes Neil Armstrong

Eli Lilly and Company Syneos Health, UK

MeddiQuest

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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