This session is presented from the point of view of seasoned MDR-compliant CER medical writers. In this 45-minute live Q&A, we will answer questions regarding critical concepts for a clinical evaluation report template such as safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio. We hope to provide you with best practices and writing strategies to support solid planning during your own writing process.
During this session, come prepared with your questions for our experts to answer. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also, please be aware that answers will be limited to 3 minutes per question.
This forum will answer questions on a first come first serve basis, so please submit all your questions when you register for this event.
Click here to watch the recording of this session.
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions.
Are you looking for best tips on how to create a robust systematic literature review process? And maybe even an informative case study illustrating the process? Watch our webinar on effective systematic literature review for post-market surveillance to understand how to continually support your device once your clinical evaluation report is completed and submitted. Learn how leveraging published data can help meet regulatory expectations and inform internal decision-making, the steps for conducting a methodologically-sound SLR, and even how data obtained through SLR can empower the successful execution of post-market surveillance activities, drive efficiencies, and support regulatory compliance.
Do you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant?
Download our free white paper, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
Joining Criterion Edge’s President Laurie Mitchell, is our guest speaker, Queenita Fernandes, Medtronic’s Medical Safety Manager, Patient Monitoring & Respiratory Interventions. In this webinar, we will discuss how to deploy systematic literature review in order to augment post-market clinical surveillance, and share our best tips on a robust systematic literature review process. Following this, our guest speaker will share an informative case study illustrating more.
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.
Click here to watch the webinar recording.
Performing a methodologically sound literature review in the early stages of product development, as well as in the later stages, can help reduce most of the inadequacies highlighted by the European Commission in section A6 of MEDDEV 2.7/1 revision 4. Section A6 provides examples of studies that lack scientific validity for the demonstration of adequate clinical performance and/or safety.
Here are the seven areas highlighted in section A6 of MEDDEV 2.7/1 revision 4 that manufacturers tend to have the most problems in proving scientific validity:
Read more about the implications of these problems and how to improve in our blog post, here.
Author: Suzanne Broussard
The newest guidance documents for post-market clinical follow-up (PMCF) requirements have just been released by the Medical Device Coordination Group (MDCG). The two documents provide guidance templates for the PMCF plan and the PMCF evaluation report to help manufacturers meet the stricter regulatory requirements under Medical Device Regulation (MDR) 2017/745.
Here are the links to the 2 newest PMCF guidance documents:
These templates should help manufacturers understand more clearly what needs to be included in the PMCF as well as present the information in a harmonized manner. Indeed, these templates provide guidance on the presentation of post-market clinical data to assist notified bodies and competent authorities find information in an organized format.
The PMCF plan template provides a clear outline of the PMCF plan in Sections A through G. The intent is that PMCF is a continuous process designed to “proactively collect and evaluate clinical data from use in or on humans of a CE marked medical device, placed on the market or put into service within its intended purpose, as referred to in the relevant conformity assessment procedure.” Presenting all this data in an organized, cohesive, and convincing manner just got a little easier thanks to the PMCF document templates.
The PMCF plan is designed to be implanted and the results documented in the PMCF evaluation report. The link between the 2 is evident by the symmetry in these templates.
(more…)Author: Suzanne Broussard
Post-market clinical follow-up (PMCF) requirements have increased under the newest Medical Device Regulations (MDR) 2017/745. All medical devices will be required to meet these standards, and the deadline is here. The possible 1-year extension for the application of MDR might give manufacturers a little wiggle room to achieve compliance, but not much.
The European Commission (EC) states in a nutshell that one of the reasons for the new regulations is to strengthen post-market surveillance requirements for manufacturers.
The goals for these new regulations are to:
The EC considers these newest regulations as providing extremely important improvements to modernize the current system and, therefore, medical device manufacturers need to make every effort to be compliant or risk further delays in obtaining a CE marking for their device.
In a recent post, we discussed one of the most challenging areas in the CER: Defining Measurable Safety and Performance Endpoints.
The PMCF plan must establish processes that proactively and systematically collect information from a variety of sources. These sources include serious incidents, Periodic Safety Update Reports (PSUR), field safety corrective actions, inputs on non-serious injury, undesirable side-effects, trend reports, literature, databases, registers, feedback and complaint sources form users, distributers and importers, as well as publicly available information on similar medical devices (MDR 2017/745, Annex III).
(more…)The EU’s new medtech regulations introduce much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. What do they entail, and why are there problems in understanding what will be required? Consultant Sarah Sorrel offers insights in an interview with Medtech Insight.
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.
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.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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