Are You Prepared for the New EU Medical Device Regulation Webinar

In this webinar we introduce how a 3rd Party Analytical Lab Can Help Support Your Company’s Compliance with EU’s MDR.

In today’s economy, it is common for companies to outsource analytical services to third parties to save money and avoid having to specialize in every aspect of business. In the case of medical device manufacturers, using a third-party testing lab also eliminates concerns of biasing the test results in favor of a manufacturer, and may give a client added confidence in the results. There are many different testing laboratories that market service offerings — so how does one go about selecting a lab they would be proud to describe as a partner? These are questions that medical device companies must ask themselves while simultaneously weighing cost, quality and turnaround time associated with the performance and safety of their product.

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)

This webinar will delve into the offerings of an investigative lab such as EAG Laboratories, which offer services such as medical device testing, extractables and leachables, deformulation/reverse engineering, failure analysis, custom synthesis, materials identification and polymer analysis to clients in many industry sectors. This webinar will showcase three examples of the types of testing offered by EAG Laboratories that aim to address requirements under the new MDR. Their case studies will include characterization of the base polymer of a medical device as well as analytical approaches for identification and quantitation of additives. The featured speakers will also discuss extractables and leachables studies designed to assess the potential for patient exposure using worst-case scenario (extractable) as well as typical exposure conditions (leachable). Finally, the webinar will also describe some possible follow-up steps after the testing is complete and results reported.

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.

In this webinar we will cover:

  • 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 EAG Laboratories, presented as case studies
  • Extractables and leachables studies
  • Potential follow-up steps after testing

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