MDR update: Common themes from medical device manufacturers

New documents and support services help manufacturers adjust to a complex regulatory environment.

Join us!

September 29, 2022 at 9 -10 am CST

Sep 29, 2022

The Date of Application for Medical Device Regulation 2017/745 established several new documents and support services to help manufacturers adjust to the new regulatory environment.

This presentation will include a review of resources developed by the European Commission, including:

  • European medical device nomenclature
  • Medical Device Coordination Group clinical investigation application documents
  • Unique Device Identification help desk

 

PRESENTERS

  • Evangeline Loh, PhD, RAC, global manager

    Evangeline Loh holds one of the most senior positions in the Emergo by UL consulting group and has more than 15 years of global regulatory experience. Her background includes compiling European technical files and design dossiers, European technical file reviews and gap assessments, borderline classifications and more than 100 peer reviews of technical files, including clinical evaluation report reviews and responding to Notified Body findings. She specializes in borderline classification assessments, global vigilance and global regulatory strategy. As the global regulatory manager, Loh manages Emergo by UL’s in-country representation services, including EU Authorized Representative, U.S. agent and Australian sponsor, and oversees global vigilance activities for these customers. She also supervises a team of international consultants and reviews dozens of device submissions and clinical evaluation reports each year. Prior to joining Emergo by UL, she held positions at Cook Incorporated and The Association of American Medical Colleges. Loh holds a doctorate in pharmacology from the University of Texas Health Science Center at San Antonio and studied microbiology at Cornell University. She joined Emergo by UL in 2007.