Chicago Chapter: EU In Vitro Medical Device Regulation (IVDR Requirements-2019)

RAC Credits
Thursday, 27 June 2019 (5:30 PM) - Thursday, 27 June 2019 (8:30 PM) (Eastern Time (US & Canada))
26525 N Riverwoods Blvd
Mettawa, Illinois, USA, 60045-3440

RAPS Member: $30
Nonmember: $45

On 5 May 2017, the European Commission adopted the In Vitro Medical Device Regulation (EU IVDR) 2017/746. There is a five-year transitional period, ending in May 2022, after which the regulation will take effect. IVD manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards.

 Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Join us and learn strategies that can help your company navigate the higher level of scrutiny, including:

  • key differences between the new regulation and the directives it replaces
  • data from clinical investigations vs. literature review
  • concept of equivalence
  • additional scrutiny in the pre- and post-market phase
  • how to ensure a smooth transition to IVDR certification

This program, hosted by AbbVie Inc, is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim two RAC recertification credits.

Featured speaker:
Dr. Julien Senac, PhD, global director, IVD Focus Team, TÜV SÜD