Essentials of European Medical Device Regulatory Affairs

Essentials of European Medical Device Regulatory Affairs

Essentials of European Medical Device Regulatory Affairs Janis Bayley Eli Lilly and Company Jane Arnold-Round NAMSA

Norgine Training 16 th Ja uary 2020

Theresa Jeary, Regulatory & Scientific Affairs Ltd

The Organisationfor Professionals inRegulatory Affairs

Agenda

• Housekeeping

• Legislation – MDD Vs MDR and key highlights • Who’s who – key stakeholders and useful guidance • Device classification and borderline products • Conformity assessment and technical documentation • Clinical evaluation requirements • Post Market Requirements - Vigilance / PSURs • Device labelling / IFU/advertising & promotion

The Organisationfor Professionals inRegulatory Affairs