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
Registration from 17 June to 9 July 2019
RAPS Members: $1,150
NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted.
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.
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.
Courtyard by Marriott Boston Waltham
387 Winter Street
Waltham, MA 02451
250 2nd Avenue
Waltham, MA 02451
The Westin Waltham Boston
70 3rd Avenue
Waltham, MA 02451
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.
If you wish to substitute a registrant, please send the original registrant's name, along with the replacement participant information, via email, to firstname.lastname@example.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.
Call RAPS Solutions Center at +1 301.770.2920, Ext 200
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.
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.
+1 301 770 2920, Ext 291