Recorded Webinar: Europe's new Medical Device Regulations (MDR)

 

The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include:

  • How the MDR is organized
  • Scope of the legislation
  • Device classification rules
  • New clinical evaluation requirements
  • UDI and EUDAMED database
  • Adverse event reporting
  • And much more...

You can also download a copy of the entire 350-page MDR or our white paper on the EU MDR.

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