The Impact of the EU MDR Regulation on Legacy Devices - Waltham, MA

12.0
RAC Credits
Tuesday, 16 July 2019 (9:00 AM) - Wednesday, 17 July 2019 (5:00 PM) (Eastern Time (US & Canada))
860 Winter St
Waltham, Massachusetts, USA, 02451-1449
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:  9 July 2019
Refund Deadline:  16 June 2019

RAC Credits:  12 (Upon attending and completing the program)

Will the meeting be recorded?  No

Registration to 16 June 2019
RAPS Members: $1,050 
Nonmembers: $1,150 

Registration from 17 June to 9 July 2019
RAPS Members: $1,150 
Nonmembers:  $1,250 

NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted. 

Program Schedule 

Tuesday, 16 July  (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, 17 July  (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
Gert Bos, executive director, Qserve
Lena Cordie-Bancroft, president, Qualitas Professional Services, LLC 
Mindy McCann, vp regulatory compliance, Qserve

All requests for cancellation must be received in writing or by calling customer service by 16 June. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified. 

The Conference Center at Waltham Woods 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 Conference Center at Waltham Woods:

Courtyard by Marriott Boston Waltham
387 Winter Street
Waltham, MA 02451

Embassy Suites
250 2nd Avenue
Waltham, MA 02451

The Westin Waltham Boston
70 3rd Avenue
Waltham, MA 02451


Cancellation
All requests for cancellation must be received in writing or by calling customer service by 16 June Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified. 

Substitution
If you wish to substitute a registrant, please send the original registrant's name, along with the replacement participant information, via email, to raps@raps.org. Substitutions may be accepted with written approval from RAPS by 2 July.

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


Register