Indiana Chapter: Clinical Consideration for EU Regulation 2017/745

When:  Jun 13, 2018 from 5:30 PM to 8:00 PM

Wednesday, 13 June 2018
5:30-8:00 pm CDT
The Rathskeller Restaurant
401 East Michigan Street
Indianapolis, IN 46204
+1 317 636 0396


On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745. There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device 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 breakfast and 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. Come join us to learn strategies that can help your device 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
  • The concept of equivalence
  • The additional scrutiny in the pre- and post-market phase
  • MEDDEV 2.7/1 rev. 4 as a possible first step to compliance with the MDR
  • How to ensure a smooth transition to MDR certification

This event is coordinated by the RAPS Indiana chapter and is intended to encourage knowledge sharing and community development. Refreshments will be available for all attendees and RAC holders may claim two RAC recertification credits.


Featured Speaker:
Matthias Fink, MD, clinical reviewer, Clinical Centre of Excellence at TÜV SÜD


Registration Information:
RAPS Members: $25
Nonmembers: $40

Location

401 East Michigan Street
Indianapolis, IN 46204