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Workshop | New European Medical Device Regulations:
Keeping Your Orthopaedic and Spine Products on the Market

Tuesday, June 13
1:00 pm – 4:30 pm
Room 49

viewpresentation


Speakers

Li200x200
Yuan Li, RAC, Ph.D.

Orthopedic Product Specialist/Auditor
TÜV SÜD Medical and Health Services


 



Fink200x200
Matthias Fink, M.D.

Clinical Reviewer, Clinical Centre of Excellence
TÜV SÜD Product






 

 


Description


For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.

The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.

Dr. Li will cover highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He will explain the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.

 


Attendee Takeaways

  1. Significant changes to the regulation and timeline for compliance
  2. Pros and cons of the new system
  3. How to keep legacy devices on the market

Bios

Dr. Yuan Li is an orthopaedic product reviewer with 11+ years of experience in research and regulatory affairs focused on biomechanics of the human musculoskeletal system. He is also a QMS/MDSAP auditor with experience covering a variety of device manufacturers. Dr. Li is a proven project/country manager with problem solving skills to complete projects (e.g. regulatory submissions and verification tests) to the highest standard in a timely manner. He’s an effective liaison between product development teams and competent authorities, with solid engineering understanding. Dr. Li is RAC (Global) certified with knowledge on U.S., EU, Latin America and Asia-Pacific regulations. He has authored eight peer-reviewed journal publications and five conference presentations on biomedical engineering.

Matthias Fink, M.D., is a Clinical Reviewer for CE certification under the European Medical Device Directives for orthopaedic medical devices in the Clinical Centre of Excellence of TÜV SÜD. Dr. Fink has expert knowledge in the field of orthopaedic implants and cardiac devices, and is responsible for leading clinical teams within the department. He has the ability to build successful internal and external relationships, enabling optimization and streamlining of operational clinical processes. Dr. Fink has participated as investigator and co-investigator in national and international Phase III and IV clinical trials for medical device and pharmaceutical companies. He has profound medical and scientific knowledge, with a broad understanding of musculoskeletal and degenerative diseases and the current standard of care.  


Helpful links: Start Early: Converting Your Spinal Technical File into a Class III Design Dossier | EU Proposes Changes for Importers and Distributors