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

New regulations were published June 2017 Aim today is to highlight some key changes as we discuss the current and the future legislation

Future learning opportunities: • TOPRA Introductory course (two days with case studies) • TOPRA MSC Medical Technology

Regulations published June 2017

3 year transition period

Medical Devices  Directive  (MDD)

Medical Devices  Regulation  (MDR)

Active Implantable  Medical Devices 

Directive  (AIMDD)

5 year transition period

In Vitro Diagnostics  Regulation  (IVDR)

In Vitro Diagnostics  Directive  (IVDD)

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