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Panel: EU MDR & IVDR Implications for Manufacturers & Suppliers


Michael A. Swit, Esq. (Principal, Law Offices of Michael A. Swit)


Kim Walker (Vice President of Regulatory, Quality, and Clinical Affairs, Hycor Biomedical)

Vinay Goyal (Project Engineer , Johnson and Johnson Enterprise Product Stewardship)

Valynda Machen (Principal Medical Research Manager, Regulatory, NAMSA)

Location: 210D

Date: Wednesday, February 7

Time: 8:30am - 10:00am

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: MD&M: Regulatory & Quality Update

Vault Recording: TBD

The May 26, 2017, date for official entry into force of new European medical device and IVD regulations has been reached, paving the way for full implementation of these regulations in 2020 and 2022. By May 26, 2020, medical device manufacturers active in Europe must be fully compliant with the new regulations. The five-year countdown to the IVDR’s date of application (May 26, 2022) has also begun. This session will cover what you need to know to meet compliance deadlines.

Topics to be covered include:

  • What are the key changes in the regulations?
  • What is the scope of the regulation and how is the proposed regulation organized?
  • Will medical device manufacturers see significant impacts on their current business?