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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
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.
Who are the Panelists?
Stacie Beecham and Dr. Sarah Chavez
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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
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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
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.
Who are the Panelists?
President Laurie Mitchell
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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Author: Criterion Edge Writers
The Medical Device Coordination Group (MDCG) released a new document (MDCG 2022-12) to establish guidelines for in vitro diagnostic medical device (IVD) manufacturers while the EU awaits the European Database on Medical Devices (EUDAMED), a project that was scheduled to be completed years earlier than its now-projected date of Q2 2024.
(more…)Author: Criterion Edge Writers
Already delayed by 4 years, the European Database on Medical Devices (EUDAMED), a European Union (EU) database considered to be the foundation of the EU medical device and in vitro diagnostic regulations (MDR and IVDR), now has an updated timeline for launch, according to the European Commission.
When the database becomes operational, the following timeline is expected. Of note, it remains uncertain whether EUDAMED modules will have a staggered release.
(more…)
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How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? In this webinar, our medical regulatory experts, Dr. Sarah Chavez and Stacie Beecham, answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device.
Key Takeaways
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.
Who are the Panelists?
Dr. Sarah Chavez, Director of IVD & Scientific Writing Services
Stacie Beecham, Principal Medical Writer
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
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