We’re just a few months away from the implementation of European Union’s Medical Device Regulations in May 2020, so compliance with the sweeping changes is undoubtedly a priority if your company is involved in manufacturing and marketing medical devices for the EU. If you're an IVD manufacturer, you must prepare for the coming In Vitro Diagnostics Regulation (IVDR), taking effect in May 2022.
The new regulations aim to modernize the processes by which medical devices and IVDs come to market. “All actors involved with medical devices, from their manufacture to their use, will have to comply with the new regulations by May 2020 (May 2022 for in vitro diagnostic medical devices),” writes the European Commission. “It is important that all actors are fully aware of the changes and start preparing for the implementation of the new regulations as soon as possible.”
Several sessions at the upcoming Medical Design & Manufacturing (MD&M) West 2020 conference program on February 11 will provide key perspectives on preparing for the EU MDR and IVDR. Attendees will hear from regulatory affairs professionals from medical device and IVD companies such as Edwards Lifesciences, Zap Surgical, Abbott, and Agendia. Anthony Rizzo, assistant vice president healthcare development at BSI Medical Devices, will also speak; BSI's UK notified body was the first in Europe to be designated to the new MDR (EU 2017/745).
Attendees will also hear from regulatory experts such as Kim Trautman, formerly with FDA and now executive vice president, medical device international services at NSF International; Kim Walker, independent global regulatory affairs, quality assurance, and clinical affairs consultant at Kim Walker Consulting; and other experts.
Feb 11. conference sessions in Room 210D include:
- 10:45 – 11:45 am Panel: Strategies for Implementing the New EU MDR Requirements
- 1:15 to 2:00 pm EU MDR & IVDR Compliance: Tales from the Trenches
- 2:05: 3:00 pm How to Design an Easy to Maintain Risk Management System
- 3:15-4:00 pm: The Impact of IVDR Requirements on Manufacturers and Strategies
In addition to the paid conference sessions above, there will be a free on-floor session at Tech Theater (Booth 637) on EUDAMED on Thursday at 1:30 pm. Entitled EUDAMED and Global UDI Registration. Are you ready? the session will be presented by Corey Cashmere, global healthcare solutions at atrify GmbH.
The changing regulatory landscape thanks to the EU MDR and IVDR was included in MD+DI's annual trends review, Medtech Trends to Watch in 2020.