RAPS Texas Chapter: EU In Vitro Diagnostic Device Regulation—Are You Prepared for the Changes?

Come engage with professionals from your local regulatory community over dinner and hear an interactive presentation on the new EU In Vitro Diagnostic Device Regulation (IVDR) in the European Union. This event is coordinated by the RAPS Texas Chapter and is intended to encourage knowledge sharing and community development. A meal will be provided. RAC holders may claim 1.5 RAC recertification credits.

The new EU IVDR will replace and repeal the existing IVD Directive 98/79/EC when it is published, currently expected during the second quarter of 2017. With the aim of tightening and strengthening the approval system for IVDs, the new regulation introduces a number of important changes, including:

  • Scope of regulated IVDs
  • Classification and conformity assessment requirements
  • Person responsible for regulatory compliance
  • Identification and traceability
  • Performance evaluation report
  • Vigilance and market surveillance
  • Notified Bodies
  • Timetable for introduction and transition

Come join us to learn how you can proactively prepare for the introduction of, and transition to, the new EU regulation once it comes into effect.

Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate.




  • At a Glance
  • Objectives
  • Agenda
  • Speaker
  • Registration Info
  • Cancellation

At a Glance

Date:

Thursday, 20 July 2017  (6:00–8:00 pm CDT) 

Location:

Emergo Group Headquarters 
2500 Bee Cave Road, Building One,
Conference Room B120
Austin, TX 78746 

Directions are available online or by calling +1 521 222 0262.

RAC Credits:

1.5 RAC certification credits upon completion of the program 

Registration Fees:

Prior to 13 July 2017
RAPS Members: $30      
List: $45

On or after 13 July 2017
RAPS Members: $40     
List: $55

Objectives

Upon the presentation’s conclusion, you’ll have a better understanding of

  • Planning for significant increases in both personnel and financial resource
  • The increased role of Notified Bodies under the regulation and how it will extend approval times and costs
  • Transitioning your current devices to new certificates
  • Maintaining an up-to-date quality management system (QMS)

Agenda

Thursday, 20 July 2017 (6:00–8:00 pm CDT)

6:00–6:30 pm          Registration, Networking and Refreshments
6:30–8:00 pm          Speaker Presentations and Q/A Session

Speaker

Susan Mecca, technical manager, medical devices, LRQA North America 

Registration Info

Prior to 13 July 2017
RAPS Members: $30      
List: $45

On or after 13 July 2017
RAPS Members: $40     
List: $55

Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate.

>> Registration Online

>> Registration Form (PDF) – for registration by mail or fax.

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.

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

Program Contact

Trilo Das, chair, RAPS Texas Chapter

Wesley Carr, senior program manager, chapter and volunteer relations, RAPS

 

 

 

Cancellation

Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.