RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

The Impact of the EU MDR Regulation on Legacy Devices

12.0
RAC Credits
Wednesday, 23 September 2020 (9:00 AM) - Thursday, 24 September 2020 (5:00 PM) Eastern Time (US & Canada)

In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as an online workshop. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

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 cannot be “grandfathered” into compliance and the implications are significant, from updating technical documentation to changing product labels and demonstrating robust clinical evidence. Manufacturers must ensure their transition plan meets these new requirements in order to continue marketing their devices on the EU market.

Join RAPS for a two-day workshop to ensure your transition plan includes the key requirements for device compliance on 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 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.

 

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

 

Program Schedule

Topics will include (but are not limited to):

 

Wednesday, 23 September (9:00am–5:00pm)

 

  • Interpreting the transition timelines
  • Challenges with notified-body designation
  • Understanding and selecting a conformity assessment
  • Impact on the Quality Management System
  • Classification changes on legacy devices
  • New “essential” requirements (general safety and performance (GSPR) requirements) and other “watch out” requirements
  • Use of ISO vs EN standards
  • Labeling changes – new requirements and symbols

 

Thursday, 24 September (9:00am-5:00pm)

  • Rebuilding the technical file
  • CER requirements
  • Planning for continuous PMS and PMCF
  • Strategy planning

  

In group activities, attendees will work on:

  • Identification of key activities and milestones
  • Priority setting
  • Budgeting resources for short- and long-term

 

NOTE: The agenda may vary based on changing requirements. This workshop will be recorded.

 

Faculty

 

Pricing

Before 23 August:

Member – $800

Nonmember – $900

 

24 August – 21 September 2020

Member – $900

Nonmember – $1,000

 


RAPS Online Workshop Experience

Join from anywhere to advance your continuing education goals and earn RAC credits. Secure and high-quality live online classroom experience. Interactive tools to foster collaboration. Peer-to-peer engagement and support from instructors.

Cancellation or Substitutions

RAPS reserves the right to cancel this program at its sole discretion.

All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.

Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived.  Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months.

Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.  Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event.

 

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

 

Program Contact

Stephany Evans

sevans@raps.org

+1 301 770 2920 Ext 229