Medical Device Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR) EU Compliance, Strategies and Goals
Program Speaker:
Evangeline Loh, Ph.D., RAC (US, EU)
Global Manager, Regulatory Affairs
Emergo by UL
Event Agenda
DATE: Tuesday, 05 Dec 2023
TIME:
6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:30 PM Program Presentation
7:30 – 8:30 PM Q & A
LOCATION: This is a virtual event
- Click here to register for this event (Virtual attendance option). If you register to attend virtually, you will receive the zoom link 1 to 2 days before the event. ·
Program Details
This presentation will provide context to the regulation as well as an outline of the main elements of the legislation (Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostic Devices Regulation (IVDR, 2017/746)), both of which were published in April 2017. The amending legislations will also be profiled (April 2017 to IVDR DoA): expansion of legacy device definition to MDR, one-year delay in MDR DoA, and extension of compliance dates for legacy devices to IVDR. An explanation of the events that led to Regulation 2023/607, which delays MDR compliance dates for legacy devices and eliminates sell-off dates for medical devices and IVDs, will be shared, including regulatory strategy considerations related to Regulation 2023/607.
Lessons learned from MDR and IVDR compliance will be addressed, as will common notified body findings from MDR and IVDR assessments. There will be general advice and recommendations to consider in a manufacturer’s compliance journey and a reminder of areas that all manufacturers must address in the future.
Speaker Biography
Evangeline Loh, Ph.D., RAC (US, EU) , Emergo by UL, Manager, Global Quality & Regulatory Affairs
During her over 17-year tenure at Emergo by UL, Evangeline has assisted hundreds of manufacturers with global regulatory strategy, registration and consulting projects. Evangeline’s areas of expertise include European CE Marking, clinical evaluation reports, and now performance evaluation reports, global vigilance, and device classification in markets worldwide. She has been intimately involved in the EU transition from the Directives to the Regulations, and all the related regulatory requirements.
Evangeline is a key architect in developing tools for Emergo’s Regulatory Affairs Management Suite (RAMS) software. She has most recently been championing the organization’s Thought Leadership presence, as well more visibly sharing Emergo by UL’s global regulatory expertise.
She previously worked for Cook Medical as a regulatory scientist and at the Association of American Medical Schools lobbying for medical schools and graduate research programs. She has her Regulatory Affairs Certification (RAC), US and EU, in the days before there were discipline specific RACs, holds a Ph.D. in pharmacology from The University of Texas Health Sciences Center at San Antonio, and a B.S. in microbiology from Cornell University.
While she would purport that she has no spare time, if she did, she would enjoy contemplating methods of how to be more efficient, working-out as a means to enjoy food, and traveling for leisure.
Registration Information:
Registration to attend VIRTUALLY ends Monday, 04 December 2023
Click here to register for this event (Virtual attendance option)
Contact
Pricing – Registration
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Cancellation Policy
There will be no refunds for cancellations.
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