Rollercoaster Ride Ahead: Time Is Short for EU IVDR Transition

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RAC Credits
Virtual Programs
Wednesday, 10 November 2021 (10:00 AM) - Thursday, 11 November 2021 (3:30 PM) Eastern Time (US & Canada)

The EU IVDR substantially changes the regulatory framework for placing any new in vitro diagnostic medical device on the market, but it does not provide much clarity and guidance on the interpretations of the new requirements. Also, the framework for product conformity assessments by Notified Bodies, and the essential central European Database EUDAMED are far from complete.

Legacy devices cannot be “grandfathered” into compliance and the implications are extremely significant, as most currently self-regulated products will need to be certified externally before 26 May 2022. The impact ranges from updating technical documentation with the addition of many new reports, to changing product labels, and demonstrating robust clinical performance evidence.

At this stage, manufacturers must be finalizing their transition plan for applying these new requirements to keep their devices in the EU market. 

This workshop is aimed both at the mid-level regulatory affairs professional who is responsible for applying the EU IVDR requirements to his/her organization’s products and the deciding management levels in the organization. Knowledge of the IVDD is not required but does help provide a better understanding the of the impact of the changes on legacy products. It will enable attendees to leave the workshop with a clearer path for creating the transition plan. 

Program Schedule 

10 November 2021 (9:00am–5:00pm) 

Topics will include (but not limited to): 

Interpreting the transition timelines 

  • Key changes to the legislation
  • Classification changes on legacy devices 
  • No grandfathering means way more conformity assessments 
  • Initial certification for legacy devices 
  • Working with Notified Bodies and understanding their expectations
  • Challenges with notified body designation
  • Distances sales and CDx


11 November 2021 (9:00am-5:00pm) 

  • Performance Evaluation including PEP/PER requirements 
  • Planning for continuous PMS and PMPF
  • Labeling changes– new requirements and symbols 
  • Updating the technical documentation 
  • UDI and EUDAMED requirements


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.

 

Pricing Amounts & Deadlines 

11 November 2020 – 11 October 2021: Early Bird $480.00 Member | $540.00 Nonmember

12 October – 10 November 2021: Regular $540.00 Member | $600.00 Nonmember

 

Who Should Attend? 

This workshop is aimed both at the mid-level regulatory affairs professional who is responsible for applying the EU IVDR requirements to his/her organization’s products and the deciding management levels in the organization. Knowledge of the IVDD is not required but does help provide a better understanding the of the impact of the changes on legacy products. It will enable attendees to leave the workshop with a clearer path for creating the transition plan.


Speakers

Gert Bos

Gert Bos is an expert in European regulations based on 18 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, Head of notified body and strategic consultant. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level. From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer and consultant with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession he has been awarded as Fellow of RAPS. Gert is president of RAPS, and serves as board member of RAPS Europe.

Sue Spencer

Sue Spencer leads Qserve’s In Vitro Diagnostics (IVD) service. She has more than 30 years’ experience in the medical device and IVD industries, including extensive notified body experience. Spencer’s key areas of expertise include IVDD and IVDR regulations; QMS implementation; internal, supplier, and compliance audits; risk management; training; and working with small start-ups and multinationals. She has worked for several IVD companies where she has held positions in R&D, manufacturing, and quality assurance. Spencer worked for three notified bodies, establishing two from scratch. She chaired the European IVD Notified Body Working Group, coordinating the notified body responses to the regulations, and also participated in the Commission IVD Technical Work Group for many years. Spencer is an experienced trainer on a variety of IVD topics, and particularly enjoys creating workshops to improve hands-on experience with the requirements.


Cancellation Policy

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. All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.


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 or email raps@raps.org.

 

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