European Union Device Regulation (EU MDR)

Overview:
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 “Articles” in 10 “Chapters” and 17 “Annexes”. In contrast, the MDD has 60 pages. New requirements are added and existing requirements are expanded. The MDR is effective in May 2020 leaving limited time to prepare. These new and expanded requirements will be explained.
Attendees should have a reasonable understanding of FDA regulations.

Why Should You Attend:
The EU MDR will be effective in May 2020. Products intended to be imported into the EU must conform to these new regulations. Arrangements must be made with a Notified Body, an Authorized Representative, and a Person Responsible for Regulatory Compliance. There is extensive preparation necessary. This webinar will explain what needs to be done to meet the deadline.

Areas Covered in the Session:
•  EU MDR objectives
•  QMS requirements
•  Device classification changes
•  Documentation requirements
•  Clinical evaluation requirements
•  UDI and labelling requirements
•  Post-market surveillance
•  New Notified Body obligations
•  Human Factors/ Usability requirements