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Chicago Chapter Webcast: Sufficient clinical data? EU MDCG Guidance Documents Explained

2.0
RAC Credits
Monday, 03 August 2020 (11:00 AM) - Monday, 03 August 2020 (1:00 PM) Central Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.

Description

The medical device regulation 2017/745 was published in May 2017 and was amended in April 2020 to include a delay of Date of Application by one-year on 26 May 2021. This additional year can prepare the clinical evidence needed to show compliance with this regulation. 

The text of the regulation MDR includes higher clinical requirements for all devices. There is a need to clarify the level of evidence needed for devices moving from the old directives to the new regulation in comparison to devices entering the market for the first time the new legislation. The medical device coordination group MDCG published various guidance on this topic (also mentioned during this program).

Attendees to this webcast will learn:

A Q&A session will be provided in the middle and end of the webcast.

This event is brought to you by the RAPS Chicago chapter to encourage knowledge sharing and community development. RAC holders may claim 2.0 RAC recertification credits.

Learning Level: 
Intermediate

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 

This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. 

Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the 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 before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured Speaker:
Dr. Bassil AkraCEO, QUNIQUE GmbH