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.
Key Takeaways
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
In September 2022, European Commissioners published updates to the Manual on Borderline and Classification for Medical Devices, which provides clarifications for classifying devices as medical or in vitro diagnostic devices under the MDR and IVDR. This guidance describes how to distinguish medical devices from medicinal products, biocides, and personal protective equipment, and how to distinguish between in vitro diagnostic medical devices and general laboratory equipment.
In this “Critical Concepts” webinar, we discuss rules for device classification under each regulation, as well as the risk-based classification rules as described in MDCH 2021-24 and MDCG 2020-16.
Key Takeaways
Learn the potential impact of risk-based classifications on your data collection strategies
Understand how to support data sufficiency in the CER and PER
Gain best-practice strategies for device classification
Who Should Watch?
Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.
In this webinar, we review the conformity requirements for legacy devices under the MDR and established devices under the IVDR to help you harness the potential of effective post market activities.
We discuss how legacy devices, defined as those previously certified under MDD/AIMDD, can demonstrate conformity to the general safety and performance requirements under the MDR through a collection of pre-market and post-market data.
Key Takeaways
Learn which types of clinical data are appropriate to use for legacy devices
How to effectively identify, present and analyze clinical data for both MDR and IVDR requirements
Understand the MDCG 2020-6 guidance on clinical data for legacy devices
Who Should Watch?
Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for IVDR or MDR submissions.
Presented from the point of view of seasoned MDR-compliant CER medical writers, this session takes a practical approach to define safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio related to the CER. Our experts discuss how to develop MDR-aligned safety and performance objectives, how clinical outcomes are leveraged, and tie it all together in the Risk-Benefit section of the CER.
Key Takeaways
How to effectively identify, present and analyze CER parameters
Understand how clinical outcomes differentiate from S&P objectives
Learn how these key foundational concepts “tell the story” of the CER
Who Should Watch?
Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
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