Are You Prepared for the New Requirements of the EU’s Medical Device Regulation?
How a 3rd Party Analytical Lab Can Help Support Your Company’s Compliance with EU’s MDR
Recorded: Thursday, March 5, 2020
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.
What you will learn:
- 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
About the Presenters:
Carolyn J. Otten, Ph.D., Senior Manager of Analytical Services
Carolyn J. Otten, PhD has over 15 years of experience in directing and performing analytical chemistry investigations. Dr. Otten has served as a scientific-technical consultant and expert witness, providing testimony for cases involving product liability and patent infringement. She has designed and managed projects involving contaminant identification, polymer characterization, reverse engineering/deformulation, failure analysis and investigative analytical chemistry projects. Skilled in communicating results to clients, she is responsible for technical accuracy and data quality. Dr. Otten received her Bachelor of Science degree in Chemistry from Missouri University of Science and Technology (formerly University of Missouri-Rolla) in 1997 and her PhD in Chemistry in the area of nanoscience and materials chemistry from Washington University in St. Louis in 2004.
Scott Graham, Ph.D., Team Leader Analytical Services
Scott Graham, PhD has a background in analytical and inorganic chemistry with five years of industry experience in the field of analytical chemistry. Dr. Graham began his career as a bench chemist and now serves as a project manager. Dr. Graham specializes in non-routine work related to the reverse engineering of pharmaceuticals, medical device analysis, consumer product analysis and contaminant isolation/identification. Each project is an interesting and unique endeavor, but all share a common goal of helping the client solve their problems with meaningful solutions using the vast array of experience and technology within the EAG network. As the world continues to grow and evolve, new markets and regulations continue to emerge. Dr. Graham and the EAG team aim to provide analytical support whether that involves preparing upfront to comply with new regulations or quickly finding solutions when adversity strikes.