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The Impact of the EU MDR Regulation on Legacy Devices

12.0
RAC Credits
Thursday, 12 March 2020 (9:00 AM) - Friday, 13 March 2020 (4:00 PM) Pacific Time (US & Canada)
860 Winter St
Waltham, Massachusetts, USA, 02451-1449

The EU MDR will apply to legacy devices with valid MDD certifications. Join RAPS for a two-day workshop to help you create a transition plan to keep your device in the EU Market.

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 March 2020
Refund Deadline: 11 February 2020

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

Will the meeting be recorded? No

Registration to 12 January 11 February 2020
RAPS Members: $1050
Nonmembers: $1150

Registration from 12 February 9 March 2020
RAPS Members: $1150
Nonmembers: $1250

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


Program Schedule
Thursday, 12 March (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

Friday, 13 March (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

Cancellation or Substitutions
All requests for cancellation must be received in writing or by calling customer service by 11 February. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified. Substitutions may be accepted with written approval from RAPS by 27 February 2020. Details related to cancellations or substitutions should be sent via email to raps@raps.org.

Location
The Conference Center at Waltham Woods
860 Winter Street
Waltham, MA 02451

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

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