The EU MDR significantly changes the regulatory framework for placing any new medical device on the market, but it does not provide any specific instruction for applying the new requirements to legacy devices with valid certifications under the MDD. Legacy devices can no longer be “grandfathered” into compliance and the implications are significant, from updating technical documentation, to changing product labels, and demonstrating robust clinical evidence. Manufacturers must start considering their transition plan for applying these new requirements to keep their devices in the EU market.
This workshop is aimed at the mid-level regulatory affairs professional who is responsible for applying the EU MDR requirements to his/her organization’s products. Knowledge of the MDD is not required but does help provide a better understanding the of the impact of the changes on legacy products and will enable attendees to leave the workshop with a clearer path for creating the transition plan.
Registration Closes: 27 November 2018
Refund Deadline: 4 November 2018
RAC Credits: 12 (Upon attending and completing the program)
Will the meeting be recorded? No
Registration to 4 November 2018
RAPS Members: $850
Nonmembers: $950
Registration from 5 November to 27 November 2018
RAPS Members: $950
Nonmembers: $1050
NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted.
Program Schedule
Tuesday, 4 December (9:00am–5:00pm)
Topics will include (but not limited to):
Interpreting the transition timelines
• No grandfathering means more conformity assessments
• Impact on OBL manufacturers CMR substances
• Classification changes on legacy devices
• Certification renewals for legacy devices
• Challenges with notified body designation
Wednesday, 5 December (9:00am-5:00pm)
Labeling changes for legacy devices – new requirements and symbols
• Use of ISO vs EN standards
• Planning for continuous PMS and PMCF
• CER requirements
• SSCP uploads to Eudamed
• Updating the technical documentation
In group activities, attendees will work with:
• Considerations for product termination vs continuation
• Priority setting
• Portfolio revision
• Budgeting resources
NOTE: The agenda may vary based on changing requirements.
Faculty
Lena Cordie, president, Qualitas Professional Services, LLC
Gert Bos, executive director, Qserve
All requests for cancellation must be received in writing or by calling customer service by 4 November. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified.
Location
University of St. Thomas
1000 LaSalle Avenue, Schulze Hall, Room #421
Minneapolis, Minnesota 55403-2003
The University of St. Thomas Conference & Event Center will host the RAPS Legacy Products workshop in its state-of-the-art, technologically advanced event space.
Accommodation Options
Below is a list of nearby hotel properties near the University of St. Thomas.
Minneapolis Marriott City Center (located 3 blocks away, available via indoor skyway)
30 South 7th Street
Minneapolis, MN 55402
612-349-4094
Embassy Suites Downtown Minneapolis (located 6 blocks away)
12 South 6th Street
Minneapolis, MN 55402
612-334 0619
DoubleTree Suites by Hilton (located across the street)
1101 LaSalle Avenue
Minneapolis, MN
612-332-6800
Hampton Inn & Suites Minneapolis Downtown
(located 3 blocks from campus available via indoor skyway)
19 North 8th Street
Minneapolis, MN 55403
612-341-3333
Cancellation
All requests for cancellation must be received in writing or by calling customer service by 4 November. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified.
Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email to raps@raps.org. Substitutions may be accepted with written approval from RAPS by 20 November.
Proof of Attendance
RAPS will send an electronic letter or a certificate of attendance upon request.
Questions
Call RAPS Solutions Center at +1 301.770.2920, Ext 200
Other Information
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.
Registration Form
If it is your preference, please use the Registration Form to register by mail, email or fax. To expedite your registration for mail orders, your employer must include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer.
Program Contact
Nichelle Sankey
nsankey@raps.org
+1 301 770 2920, Ext 291