The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence, with up to 80% of IVDs requiring Notified Body certificates under IVDR.
In October 2022, the AAMI/FDA/BSI Annual Conference sought to discuss current knowledge and practical strategies to meet these new clinical evidence requirements. Dr. Sarah Chavez, Criterion Edge Director of IVD Writing Services, was honored to be an invited speaker and join with other regulatory, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”.
Attendees to this Criterion Edge webinar will benefit from key insider insights gleaned from this meeting, as Sarah will be share and discuss the key take-aways from the Symposium, including clinical evidence requirements and strategies to keep your report writing and data collection on track. Most companies are in the early stages of planning for IVDR, so the goal of this webinar is to provide helpful suggestions for IVDR planning and preparation from the perspective of experienced regulatory writers.
What are the major changes from IVDD to IVDR?
How does IVDR define “Clinical Evidence,” and where can you find it?
What are the Notified Body’s expectations (and advice)?
Who Should Watch?
Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of performance evaluation reports for IVDR submissions.
Who are the Panelists?
Dr. Sarah Chavez, Director, IVD & Scientific Writing Services
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