Indiana Chapter Webcast: MDR Update and Status of Implementation

When:  Dec 4, 2019 from 3:00 PM to 4:00 PM (ET)

RAPS Members:  $25
Nonmembers:  $35

Join the RAPS Indiana chapter online or in-person to hear Dr. Bassil Akra, vice president at TÜV SÜD speak on the implementation status of the EU MDR update. When registering, you will automatically be selected for the webcast. If you are local and want to attend in-person at Barnes & Thornburg LLP, make sure to add this option to your cart prior to checking out.

On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745. There is a three-year transitional period, ending in May 2020, after which the regulation will take effect. The new regulation introduces larger scope, more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification.

Device manufacturers have the duration of this transition period to update their technical documentation and quality management processes to meet the new requirements. Come join us and learn strategies that can help your device company navigate the higher level of scrutiny, including:

  • The scope of the new regulation
  • The new classification rules
  • The new conformity assessment rules
  • The technical documentation expectations
  • The increase pre- and post-market clinical requirements
  • The new reporting requirements

This activity, hosted by Barnes & Thornburg LLP, is brought to you by the RAPS Indiana chapter and is intended to encourage professional development and engagement with others in the local regulatory community. Light refreshments will be provided at the in-person event and RAC holders may claim one RAC recertification credits whether they attend in-person or register for the webcast.

Featured speaker:
Dr. Bassil Akra, vice president, global focus teams, TÜV SÜD

How Does It Work?

Virtual Only...
For the best webcast experience, please use a Google Chrome browser. RAPS Webcasts are also mobile and tablet accessible for your convenience. Registrants will receive instructions on how to log in 48 hours prior to the start of the webcast. A live Q&A portion with the speaker(s) will follow the presentation and all registrants will have access to the presentation slides and the on-demand recording for one year.

In-Person Event...
Show up onsite at Barnes & Thornburg LLP by 2:30 pm. Enjoy some light refreshments and network with your colleagues. Watch the live webcast with the group and then engage in a group discussion about the content. Those that participate in the In-Person event will also have access to the presentation slides and the on-demand recording for one year.