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.

Welcome to the Advanced Manufacturing West 2019 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.

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