IVDR: Implementation NOW - Learn from early adaptors

12.0
RAC Credits
Wednesday, 16 June 2021 (9:00 AM) - Thursday, 17 June 2021 (3:00 PM) Eastern Time (US & Canada)

Roughly 85% or more of the IVD products currently on the market are self-certified and have not been scrutinized by a Notified Body but will require Notified Body oversight for IVDR CE certification. It is crucial for regulatory professionals to keep up-to-date with developing guidances and know how to implement the IVDR requirements within their company to be assured of CE marking in time to meet the IVDR deadlines.

This workshop will look at what we know and have learned in the last year, building the new requirements and processes into the QMS to support pre- and post-market devices, and know the extent of IVDR Technical Documentation and handling of "legacy data" to successfully assemble their Technical Documentation file. It is best suited for professionals who are already familiar with the IVDR and are looking to build practical experience.

Who Should Attend

This workshop is directed to attendees who are already familiar with the IVDR and are looking to build current thinking and practical experience. Participants will benefit from working on challenging exercises and working with hands-on case studies.


Pricing Amounts & Deadlines

5 February 2021–14 May 2021: Early Bird Member $800 | Nonmember $900
15 May 2021-15 June 2021: Regular Member $900 | Nonmember $1000


Objectives

    Apply the latest knowledge from new guidances and lessons learned by a Notified Body to:
  • Make their IVDR Quality Management System operational.
  • Determine the extent of IVDR Technical Documentation and handling of "legacy data" to successfully assemble their Technical Documentation file for submission.

Agenda

Day 1  Wednesday, 16 June 2021 Eastern Time (US & Canada)

9:00 am-9:15 am        Introduction

9:30 am-10:30 am      Current State of Play with the IVDR

  • What do we know now that we did not know last year at this time?
  • What do we still not know?
  • What is not in your control?
  • What is in your control and what to do.

10:30 am-10:45 am    15-minute break

10:45 am-11:30 am    QMS Must Haves…

  • Meeting the requirements for Relationships with Economic Operators:Authorized Representative, Importer, Distributors
  • Short exercise
  • Person responsible for Regulatory Requirement (PRRC);
    • Expectations  - Hosting the on-site Notified Body Audit (…. i.e. how to handle NB requests to take samples etc.)
  • Implementing Post Market Surveillance, Vigilance procedures Clinical Evidence and new elements - PSUR, Eudamed, Processes for PMPF

11:30 am-12:00 pm    Regulatory Strategies - Risks to consider in making your Regulatory Plan

  • Considerations for the long game; what to be aware of in determining your strategy.
    • Short exercises - case examples

12:00 pm- 12:45 pm   Lunch

12:45 pm-2:00 pm      Applying the classification Rules and Selecting a Conformity Assessment Route 

  • Intended Use drives classification
  • Classification drives conformity assessment strategy
  • Short exercises - case examples

2:00 pm-2:15 pm        15-minute break

2:15 pm- 2:30 pm       Review Group Exercise 

2:30 pm-3:00 pm        Panel Discussion    All speakers

3:00 pm                       End of the day

 

Day 2 Thursday, 17 June 2021 Eastern Time (US & Canada)

9:00 am-9:15 am        Introduction

9:00 am-10:30 am      Case Study Exercises                             

  • Classification
  • Conformity Assessment choices
  • What Regulatory Strategy and why?
  • Special considerations

10:30 am-10:45 am    15-minute break

10:45 am – 12:00 am  Technical Documentation: Best Practices – Organization and Assembly of

the Technical Documentation File

  • Lessons learned from the MDR
  • Notified Body Perspective
  • Demonstration General Safety and Performance Requirements
  • Application to the presented Case Study - Challenge exercises
  • How to approach and manage a new submission with “legacy data”
  • How to manage the new clinical evaluation requirements
  • Application to the presented Case Study - Exercise
  • Maintaining the Technical Documentation - Living Documentation

12:00 am - 12:45pm   Lunch

12:45 pm-2:00 pm      Clinical Evidence, Clinical Performance Investigation; Post-Market

Performance follow up

  • Having enough clinical data
  • Clinical evaluation process and risk management, including Performance Evaluation Presentation
  • Group Exercise / Application to the Case Study

2:00 pm – 2:15 pm     15-minute break

2:15 pm – 2:30 pm     Review Group Exercise 

2:30 pm - 3:00 pm      Panel Discussion    All speakers

3:00 pm                       End of meeting


Speakers

Connie Del Buono, Synoptyx In
Connie provides guidance for managing the quality and regulatory functions in medical device companies. She has 37 years of experience in the management of in vitro and medical devices manufacturing and their regulation. She has been a certification project manager for a Notified Body for eight years and continues on contract to perform audits and Technical File reviews. She has performed numerous assessments of non-active and in vitro diagnostic medical device dossiers for safety, performance, and regulatory requirements for CE marking. Connie is a frequent ASQ and RAPS speaker and teacher in quality management systems and regulatory compliance and has a focus on the European IVDR. She is Notified Body / Registrar, certified in the MDD, MDR and IVDD European Medical Device Directives, ISO 9001:2015, ISO 13485:2016 and MDSAP and is focused on implementation of the IVDR. She has also taught IVD regulatory compliance at Ohlone College in California and at UC Santa Cruz Extension program.


Dr. Andreas Stange, TÜV SÜD
Andreas F. Stange, PhD is a vice president for the medical and health services group at TÜV SÜD Product Service. He serves as the global representative, responsible for the invitro diagnostic devices business line.

Dr. Stange joined TÜV SÜD in 2001 as a medical device expert where he has held various positions since joining the organization. He was previously president & CEO of TÜV SÜD in Japan.



Anja Wiersma, mi-CE Consultancy
Anja Wiersma, PhD is a medical biologist by training with a PhD in the neuroharmacological –behavioural - physiology field. After working for eight years at a multinational pharmaceutical company (Organon), first as scientific researcher and later as a strategist in the department of Strategy and Business Development, she transitioned to the field of medical devices and in vitro diagnostic medical devices.




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 event title.

Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.

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.