ATX West, MD&M West, Plastec West, West Pack, and Design & Manufacturing West is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

2020 MDM West Presentation Viewer


Welcome to the MDM West Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

Sign In Create Account Export | Need Help?
All Sessions Speakers My Schedule

The Impact of IVDR Requirements on Manufacturers & Strategies

Jon Goveia  (Director, Regulatory Affairs, Abbott)

Location: 210D

Date: Tuesday, February 11

Time: 3:15 pm - 4:00 pm

Track: MD&M Conference: Keeping Up & Staying Compliant with Global & FDA Regulations

Vault Recording: TBD

The IVDR requirements have brought new challenges to manufacturers who make diagnostic devices for the European market. Manufacturers are facing reclassification and new certification requirements for their products. The tight timeline, limited information from the regulations, and resource constraints with the Notified Bodies that can have the IVDR designation add more stress to manufacturers to be in compliance by May 2022.

Topics covered include:

  • Strategies for performing the gap analysis to facilitate the new Technical File construction following the IVDR requirements
  • Processes for manufacturers to be fully in compliance on all changes that will occur under the IVDR
  • Lessons learned while focusing on the IVDR implementation process