Clinical Data Sources: Leveraging Clinical Data in the Clinical Performance Report In Part 1 of our IVD Deep Dive series, we discussed the importance of selecting meaningful performance objectives and explained how these objectives help establish the acceptance criteria. Part 2 of our series will pick up from there with strategies to identify sources of […]
In this practical presentation, Dr. Sarah Chavez, will present a detailed outline of the IVDR State of the Art search within the Performance Evaluation Report (PER). Additionally, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example, the SLR approach, data screening, and data presentation will be addressed. […]
This session's topic: Tips For How to Avoid Common Notified Body Review Findings Criterion Edge is often approached by clients with MDR Clinical Evaluation Reports (CERs) that require extensive revisions based upon Notified Body review and feedback. Addressing NB feedback costs your team time and effort and may threaten critical submission deadlines. However many of […]
Ask the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and Best Practice Writing Strategies In this highly interactive question-and-answer session, Criterion Edge experts Laurie Mitchell, President, and Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, will outline the must-have elements for two very similar regulatory […]
Scoping Your MDR and IVDR Writing Projects - The Forgotten Step In most of our webinars, we’ve focused on the writing process including which steps to take and how to organize your thoughts onto paper. However, we’ve never discussed what happens before the writing process begins. So what do you need before you get started? […]
The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success Regulatory Affairs plays a critical role in supporting the current MDR and IVDR required clinical/performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. From the early planning stage […]
Ask the Expert: The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process Regulatory Affairs is poised to play a critical role in supporting the current MDR and IVDR required clinical and performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. In this session, […]
Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies 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 […]
New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in […]
The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria, therefore establishing that your IVD may be considered state of the art. Remember: the PER is a product, but it is documenting a process. Performance evaluation can be straightforward if your analyte has a well-established association […]
While the concept of a “performance evaluation” hasn’t changed much over the past two decades, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to the IVDD. Annex XIII of the IVDR specifies the contents of two new documents: the performance evaluation plan (PEP) and the performance evaluation report (PER). […]
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. Dr. Sarah […]
