The Impact of the EU MDR Regulation on Legacy Devices

When:  Nov 7, 2018 from 9:00 AM to 3:00 PM
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.

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

Program Schedule

Wednesday, 7 November (09:00 – 16:30)

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
Thursday, 8 November (09:00 - 15:00)
  • Labeling changes for legacy devices – new requirements, symbols, UDI 
  • 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, president, Qualitas Professional Services, LLC

All requests for cancellation must be received in writing or by calling customer service by 8 October. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified. 

Location

Park Plaza Victoria Amsterdam, Damrak 1-5, 1012 LG Amsterdam, Netherlands

Tel: +31 20 623 4255

Located in the center of Amsterdam, the Park Plaza Victoria hotel is your ideal starring point for both business and leisure travellers. A clever combination of antique and modern, Park Plaza Victoria Amsterdam boasts historic architecture and contemporary accommodation in the city centre, just a five-minute walk from Amsterdam Central Station. Check in to a room in our eye-catching building constructed in the 1890s. Hotel amenities include free Wi-Fi, flavourful on-site dining, a fitness centre, an indoor pool, a sauna and a solarium.

Accommodation

RAPS has negotiated a dedicated room allotment directly at the Park Plaza Victoria Amsterdam hotel for workshop participants. To benefit from these special rates, delegates are encouraged to book directly by using the hotel hyperlink above. Reservations made directly online via the hotel website or any alternative booking service sites will unfortunately not benefit from preferential rates.

Cancellation
All requests for cancellation must be received in writing or by calling customer service by 8 October. 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 24 October.

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





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Location

Damrak 1-5
1012 LG Amsterdam
Amsterdam