Our November 2019 webinar looked at how to assess products and more.
May 26, 2022 is the IVDR date of applicability, which replaces the IVD Directive. The deadline sounds far away, right? Eh… not so, considering the significant changes your organization will need to make in terms of infrastructure, planning, and resources to proceed with successful implementation. Under the IVD directives, most manufacturers were able to self-certify to place their products on the market. This is changing with IVDR as now there is an expected increase in requirement for notified body certification changing from 20% to more than 80% of all IVD products. This poses significant challenges for organizations that self-certified in the past and we are here to help.
This webinar will help you assess your products from both the portfolio-level and technical documentation level.
From a portfolio perspective, we’ll cover:
– IVDR timelines
– Updated classification rules
– Requirements of clinical data
– Cost assessment for remediation activities
– ROI based on current and changing market share using a case-study portfolio as an example.
At the technical documentation level, we’ll address:
– Details of the updated classification rules
– Conformity assessment procedures
– Economic operators
– The impact of Brexit
– Required involvement from notified bodies (a first for many companies in this space)
– Requirements for performance evaluation reports
– Submission updates
– Strategies you can take to fit all of this together
Attendees should expect to leave this webinar with a clear understanding of the regulation and actionable takeaways to get their organization moving towards compliance. This webinar is especially perfect for you and will serve as your IVDR guide! Like any significant regulation change, planning is imperative to success and we walk you through key points to help you do just that!