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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