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Getting Ready for EU MDR/IVDR Device Certification & Recertification: Updates & Implications for Manufacturers

Eri Hirumie (Regulatory Affairs Specialist, MicroVention)

Evangeline Loh, PhD (Global Regulatory Manager, Ermergo by UL)

Location: 210D

Date: Tuesday, February 5

Time: 1:15pm - 3:00pm

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

By May 26, 2020, medical device manufacturers active in Europe must be fully compliant with the new EU Medical Device Regulations. The countdown to the MDR/IVDR’s date of application (May 26, 2022) has also begun. These significant changes are increasing the pressure on manufacturers to comply to keep products on the market. In this session, we’ll discuss the current status of the EU MDR/IVD regulations and explore compliance challenges for industry.

Topics covered include:
  • What significant impacts will medical device manufacturers see on their current business?
  • Performing product portfolio assessments – is it cost-effective to recertify?
  • Effect on IVD companies who are now 80% under direct review by Notified Bodies
  • A practical checklist and a suggested timeline will be provided for manufacturers

Presentation Files

Getting_Ready_for_EU_MDRIVDR_Device_Certification__Recertification_Updates__Implications_for_Manufacturers_.pdf
Getting_Ready_for_EU_MDRIVDR_Device_Certification__Recertification_Updates__Implications_for_Manufacturers_2.ppt