Skip to main content
RAPS Euro Convergence 2023 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back
ViewAttendees 10

IVD

Domain: Regulatory Frameworks & Strategy

Knowledge Area: Regulatory Strategy Development

Research Use Only (RUO): What does this mean for legacy devices and product development of new in vitro diagnostics under the IVDR?

Friday, May 12, 2023
12:00 – 13:00 CEST
Location: Pearl 1

Supported By
Description: While not intended for diagnostic purposes, the use of RUO/RUO-grade components has long been a part of IVD development and workflows, especially in novel technology whereby no other alternative and/or suitable component exists to meet the needs of an intended purpose. With the formal implementation of IVDR in May 2022 for new IVDs and legacy devices following close behind in the transition period of notified body reviews, strategic planning of manufacturers and service providers must ensure that they can meet the regulatory requirements of the IVDR while also ensuring patient safety and access in the market.

Learning Objectives:

  • Understand the implications and considerations related to use of RUO/RUO-grade components in IVDs under the IVDR
  • Consider potential strategic options for their products to meeting the new regulatory requirements
  • Understand the benefits between patient safety and access vs. risk of removal and burden of validation if no suitable alternative exist