Essentials of European Medical Device Regulatory Affairs

Learning Outcomes

• To provide a basic understanding of European medical device regulatory

requirements and how to ensure compliance • Aim today is to highlight some key changes and discuss the current and the future legislation

The Organisationfor Professionals inRegulatory Affairs

Module 1

• Legislation in Europe • Directives Vs Regulation • Key changes in the Regulation • Transition to the New Regulations

• Guidelines (MEDDEVs) • Harmonised standards • MDCG Guidance

The Organisationfor Professionals inRegulatory Affairs