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 regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence, with […]
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 […]
Writing is not an innate talent, but a learned skill requiring extensive training and practice. Scientific writing is no exception. As scientists, we have all seen examples of how bad writing and ineffective communication can detract from good science. The goal of this presentation is to describe strategies to support effective partnerships between regulatory experts […]
Real world evidence is increasingly important for companies seeking to demonstrate device performance without the time and expense of extensive clinical trials. This webinar will explore how to effectively use real-world evidence in regulatory submissions to accelerate product approvals and meet post-market surveillance requirements. Learning Objectives: Summarize recent regulatory guidance pertaining to the use of […]
Overview Understand the intricacies of the FDA’s Pre-Determined Change Control Plan (PCCP) and its application across medical devices and in vitro diagnostics (IVDs). This webinar is designed for global regulatory and quality professionals aiming to streamline their strategies for managing post-market device modifications. Attendees will walk away with a deeper understanding of regulatory changes and […]
Here we are, nearly eight years after the publication of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and Medical Devices Regulation (EU) 2017/745 (MDR). As the May 2025 deadlines loom, many manufacturers are facing the reality of what implementing these regulations actually entails. While the manufacturers seem to have been given more […]
A well-executed systematic literature review (SLR) is more than just a regulatory compliance requirement—it’s a strategic asset for your entire organization. In this webinar, we’ll explore how a well-designed systematic literature review can support regulatory submissions, enhance competitive intelligence, and facilitate post-market surveillance while saving time, money, and resources. Using real-world examples, our experts will […]
