Chicago Chapter In-Person Event: EU MDR – Status of Play After Six Years of Official Publication

When:  Jun 14, 2023 from 17:30 to 20:30 (ET)

The European Medical Device Regulation (EU MDR) introduced fundamental changes to medical device regulation in the European Union, and stakeholders have been busy for more than six years responding to those changes and navigating the challenges and opportunities they present.

This session will review updates on the status of the EU MDR, provide helpful information regarding the recently published amendment and Medical Device Coordination Group (MDCG) Documents, and present guidance on the best approach to achieving EU MDR compliance and successful certification.


REGISTRATION FEES & DEADLINES

Free

Learning Objectives

At the conclusion of this workshop, participants should:

  • Be informed about the status of the EU MDR Implementation in the EU
  • Understand the expectations of the EU Notified Bodies
  • Be familiar with the key learning from the initial certification.

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?

Regulatory professionals engaged with placing devices on the market in the EU.


Instructors:

Bassil Akra
Chief Executive Officer, Akra Team


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.

Location

150 Saunders Rd
Lake Forest, IL 60045-2509