Upcoming Webinar Hosted by Xtalks: Are You Prepared for the New Requirements of the EU’s Medical Device Regulation?

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Learn about what to expect in terms of the scope of the testing, the analytical approach and turnaround times involved in order to address the new requirements of the MDR, which go into full-force effect in May 2020.

Xtalks Life Science Webinars

The timeline provided by MDR was three years, which extends until 25 May 2020

In 2017, the EU’s revamped Medical Device Regulation (MDR) was published, which expanded the scope of regulations and requirements that currently govern medical device manufacturers under the Medical Devices Directive (MDD); the timeline provided by MDR was three years, which extends until 25 May 2020. Major changes from the previous MDD include:

  • Elimination of the “grandfathering” mechanism, which necessitates that all medical devices on the market must apply to be accredited, regardless of whether or not they were previously approved under earlier directives
  • Empirical evaluation and testing that demonstrates that devices are biocompatible, in alignment with ISO 10993-1:2018, and not merely relying on historical data that supports a device’s safety
  • Documentation that medical devices do not contain carcinogens, mutagens, or reproductive toxic substances. This can be accomplished by identifying and quantifying the materials that compose the medical device above 0.1 percent (by weight)

Join Scott Graham, PhD, Team Leader at EAG and Carolyn J. Otten, PhD, Senior Manager of Analytical Services at EAG in a live webinar on Thursday, March 5, 2020 at 2pm EST (11am PST) to learn about:

  • What manufacturers need to know about the EU MDR
  • Overview of the scope of testing, the analytical approach and turnaround times involved to address new MDR requirements
  • Three examples of the types of tests offered by Eurofins EAG, presented as case studies
  • Extractables and leachables studies
  • Potential follow-up steps after testing

This webinar will be followed by a live Q&A with the featured speakers.

For more information or to register for this event, visit Are You Prepared for the New Requirements of the EU’s Medical Device Regulation?

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Mira Nabulsi
Xtalks
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