Thursday, 28 March 2019
8:00-11:30 am MDT
6350 South 3000 East
Salt Lake City, UT 84121
+1 801 942 4000
On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745 and the new In Vitro Diagnostic Regulation (IVDR) 2017/756. There is a three-year transition period, ending in May 2020 for the MDR, and a five-year transition period, ending in May 2022 for the IVDR, after which the respective regulations will take effect. Device manufacturers have the duration of the transition period to update their technical documents and processes to meet the standards
Join other regulatory, quality and life science professionals from your region for an interactive breakfast session on this important topic. You’ll hear from three seasoned professionals on the sections of the regulation that companies struggle with most: chapter VI, Clinical Evaluation and Clinical Investigations and chapter VII, Post-Market Surveillance, Vigilance and Market Surveillance. The parallel chapters of the IVDR will also be discussed.
By attending this session, participants will gain a better understanding of:
- How will devices and diagnostics, currently sold in the EU market, be impacted by the new regulatory changes?
- What clinical research and risk assessment methods should new product developers consider before selling in the EU?
- What areas (Quality, Regulatory and Clinical) are impacted by the new Medical Device Regulation?
- What are some planning steps to consider when beginning the implementation process?
This workshop, hosted by MasterControl and BioUtah's Regulatory, Compliance and Quality Committee, is brought to you by the RAPS Utah chapter and is intended to promote knowledge sharing and networking among professionals in the regulatory and related industry. Breakfast will be provided to all attendees and RAC holders may claim three RAC recertification credits.
Linda Chatwin, RAC, JD, senior customer solutions consultant, Health Sciences Division, Emergo, a UL Company
Dr. Kristen Kanack, PhD, senior vice president, regulatory and clinical affairs, BioFire Diagnostics, LLC
Dr. Michael Rinck, PhD, managing director, pharmacist and microbiologist, Promedt Consulting GmbH
RAPS Members: $30