RAPS Webcast: MDR by The Numbers

1.5
RAC Credits
Virtual ProgramsVirtual Programs
Thursday, 23 February 2023 (9:00 AM) - Thursday, 23 February 2023 (10:30 AM) Mountain Time (US & Canada)

After the announcement of medical device regulation (MDR)and a deadline extension, the EU market is bracing for the new requirements. Now facing the possibility of another extension, industry doesn’t even know if or when it must comply.

MDR by the numbers now:
8,120—the number of applications.
1,990—the number of certificates issued.
7000—the number of certificates that may be issued in total by May 2024.
22,793—the number of certificates under medical device directives (MDD) set to expire by May 2024.
425,00—the number of devices under said MDD certificates that will be unavailable after May 2024 without drastic and immediate action.

This webinar looks at MDR implementation by the cold, hard, numbers. The webinar presents the results of research on recent MDCG guidance, industry and Notified Body surveys, and personal interviews with stakeholders regarding their first-hand experiences with implementation.


Registration Fees

Free


Learning Objectives

At the conclusion of this workshop, participants should know:

  • Where MDR stands—an extensive look at published data from competent authorities, notified bodies and industry
  • How to review recently published MDCG guidance
  • Nuances of the MDR “extension”
  • What industry needs to do

  • Audience Learning Level:

    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.

    Who Should Attend?

    Medical Device Regulatory Professionals and Industry


    Instructors:

    Michelle Lott

    Michelle Lott

    Michelle Lott is founder and principal of leanRAQA (leanraqa.com). She's supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services—and grief counseling, because dealing with regulators can be emotionally draining! Lott served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee. She holds a BS in chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University.

    Cancellations

    RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

    All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

    To transfer a registration, email raps@raps.org with the event title, name of the original registrant, and contact information for the new attendee.


    Proof of Attendance

    A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

     

    Questions

    For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

    For account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

    Discover more of what matters to you

    News »

      10;16;18;29;31;32;