The New European Medical Devices Regulation (MDR 2017/745)

Learn more about the European Medical Devices Regulation (MDR 2017/745), including how the MDR is organized, the scope of the legislation and device classification rules.

THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

Watch now: The new European Medical Devices Regulation (MDR 2017/745)

Learn more about the European Medical Devices Regulation (MDR 2017/745), including how the MDR is organized, the scope of the legislation and device classification rules.

Webinar date

Oct. 26, 2017

Speaker

Ronald Boumans, senior regulatory consultant, Emergo by UL

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.

Learning objectives:

How the MDR is organized
Scope of the legislation
Device classification rules

New clinical evaluation requirements
UDI and EUDAMED database
Adverse event reporting

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.

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