Countdown to IVDR Date of Application – Key Requirements and Challenges

August 26, 2021 | 9-10am CDT

Preparing for the In Vitro Diagnostic Device Regulation (EU) 2017/746 (IVDR) will require manufacturers to develop new practices, apply new concepts, and potentially develop entirely new procedures in order to comply with the new standards. This webinar walks you through key milestones as your company prepares for the IVDR date of application in May 2022, including:

  • Quality Management System standards to address IVDR Article 10
  • Outlining a gap analysis between IVD and IVDR requirements
  • Annex II requirements for your Technical Documentation
  • Revised agreements with your Economic Operators
  • Confirming your Notified Body will be designated to IVDR

Aug 26, 2021