The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect for a few years, 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) will outline the most important changes you need to know including:
- 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...
ABOUT THE PRESENTER: Ronald Boumans is Senior Regulatory Consultant at Emergo’s office in The Hague. He previously served as Inspector of Medical Technology at the Dutch Healthcare Inspectorate (IGZ), and his areas of expertise include European medical device legislation, Competent Authority supervision, and CE Marking requirements.
THIS WEBINAR WAS RECORDED ON OCTOBER 26, 2017
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