IVD manufacturers planning to sell or continue selling IVD products in the EU are bracing for the upcoming IVDR transition deadlines starting in 2026 for Class C devices and continuing in 2027 with Class B devices.
For many manufacturers, the devices they plan to transition to the IVDR are also being developed concurrently to go through the FDA marketing authorization process (typically 510(k) or De Novo Request). The IVDR conformity assessment and the FDA device regulatory frameworks have key differences that must be addressed early and systematically in the design and development process to keep product commercialization on track. Without this planning, problems typically surface during the design validation stage of development, particularly in analytical and clinical validation. These issues then become the crux of the IVDR technical documentation and/or the FDA marketing authorization submission.
This webcast will identify the common pitfalls IVD manufacturers experience due to the inherent differences in the US and EU IVD regulatory frameworks. Case study examples will illustrate how planning in the design and development process could prevent these critical and often expensive failures.
Learning Objective
- Identify key differences between the IVDR conformity assessment and FDA marketing authorization frameworks that affect design and development planning.
- Recognize common pitfalls that surface during the design validation stage of development, particularly in analytical and clinical validation, when parallel EU/US regulatory requirements are not addressed early in the process.
- Apply case study lessons to integrate parallel regulatory planning into the design and development process, reducing risk of costly delays to product commercialization
Who Should Attend:
This webcast is directed towards those who work in Regulatory Affairs, Quality Assurance, Research and Development, Project Management, and IVD Executive Leadership.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Cancellations and Refunds
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 to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speaker
