Author: Criterion Edge Writers
Regulatory Affairs (RA) professionals are poised to play a key role in supporting the clinical or performance evaluation report (CER or PER) process. Regulatory Affairs is active throughout the entire process, from pre-project planning through scoping and kick-off, report writing, review and sign-off, and finally, submission to the notified body.
The CER and PER are highly complex reports—not just because of the large amount of data they contain, but because they must tell a complex story. Putting all the evidence together for a successful submission is a difficult task, but RA is strategically positioned to provide critically important support and guidance to the evaluation writing team.
Author: Criterion Edge Writers
Regulatory advertising and promotion (A&P) professionals bring a unique set of skills to their role. While they typically work within a multidisciplinary group of medical, legal, and commercial experts who review device promotional content, A&P professionals have considerable knowledge of European Union (EU) and Food and Drug Administration (FDA) regulations that can additionally benefit product development in areas outside of the promotional review process.
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 reports: the State-of-the-Art section of an EU MDR-compliant Clinical Evaluation Report (CER) and the EU IVDR Scientific Validity Report (SVR).
Participants will understand the required and critical content that is common to both documents and learn best-practice writing strategies to support successful completion of these challenging projects. Come with your questions ready to get feedback from our experts!
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.
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 or Scientific Validity Reports for IVDR submissions. Anyone interested in learning more about the requirements for these reports is also welcome to attend.
Click here to watch the recording of this session.
The large number of mentions of state of the art throughout MEDDEV 2.7/1 rev 4 provide not only a comprehensive description of the importance, purpose, and role of establishing the state of the art, but also inform on how to incorporate this analysis into the clinical evaluation. The image below summarizes several core roles of this analysis.
Establishing and describing state of the art is not an isolated task, but is central to the entire clinical evaluation. Defining the current, accepted best treatment options, and describing the risks and benefits of these options, provides essential information for multiple aspects of the clinical evaluation. Thus, establishing state of the art yields information that is essential for determining if the safety and performance of a device is compatible with current standards (in comparison to available treatment options). In other words, state of the art establishes a reference standard that is used throughout the clinical evaluation.
If you want to find out more about State of the Art according in MEDDEV 2.7/1 rev 4, you can download our full whitepaper.
This white paper is 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 and 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.
Establishing your device’s safety and performance is a critical component of the clinical evaluation process. However, how to use the state of the art section within the Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) to establish the device’s safety and performance objectives and acceptance criteria can seem ambiguous.
First, clearly understand the difference between safety and performance objectives and acceptance criteria. Then, use…
Download the rest of this white paper here.
Criterion Edge has the expertise and resources to write your Clinical Evaluation or Performance Evaluation Report. Ready for a free consult?
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 these issues might have been avoidable with thorough pre-planning, proper project scoping and asking the right questions from the beginning. In this “Ask the Expert” question-and-answer session, we will show you some of the most common issues our writing team encounters with clients who face these revisions and discuss how they can be avoided. Presented from the perspective of experienced medical writers, we hope to provide examples of how solid planning during your own writing process can help you avoid the most common missteps in your own CER or PER.
During this 45-minute session, come prepared with your questions for our experts to answer regarding your notified body review findings. Please submit them ahead of time while registering 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.
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.
Click here to watch the recording of this session.
Notified Bodies (NBs) across Europe along with global manufacturers are facing resource constraints. The cause? Additional requirements imposed by the new MDR/IVDR Regulations. Team-NB, the European notified body association, issued a position paper to express concerns about lack of resources and guidance to assist in meeting the certification deadlines.
The primary concern cited is the likely device shortage for patients. More complex and longer certification processes required under MDR/IVDR are influencing this shortage. In conjunction, the demands are too great for the small number of MDR/IVDR designated Notified Bodies (NBs). With only 25 NBs for MDR and 6 for IVDR, the demand outweighs supply. Compared with 51 NBs designated for MDD and 21 under the AIMDD/IVDD Directives, manufacturers are in a tough situation now compared to years prior.
Team-NB identified the following four primary contributing factors, summarized in our recent blog post here.
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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