The Impact of the EU MDR Regulation on Legacy Devices - Minneapolis

When:  Dec 4, 2018 from 09:00 to 17:00 (ET)
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





Location

1000 Lasalle Ave
Minneapolis, MN 55403-2025