Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated as drugs to devices, in implementing a recent court decision.
Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with capacity and new processes, are creating a clunky, slow and expensive EU regulatory system that could damage EU industry, delegates heard at the RAPS Convergence meeting earlier this week.
When it comes to guidances supporting the implementation of the Medical Device Regulation, major issues are being created because there is “no real possibility for industry to actively and meaningly engage in drafting EU guidances” and provide input on how to make the new system work efficiently, Elizabeth Gfoeller, corporate director, regulatory affairs at MED-EL, an EU manufacturer of globally marketed hearing loss solutions, told the first day of the meeting on 13 September.
Nearly four months after the full application date of the EU’s Medical Device Regulation, the EU standards bodies have updated the most critical medtech standard to align it with the new EU medtech regulations.
The European standards bodies, CEN and Cenelec, have published an update to the EU medical quality management system standard to link it for the first time with the new Medical Device and IVD Regulations.
EN ISO 13485:2016+A11:2021 features new annexes demonstrating the link between specific clauses of the standard and the general safety and performance requirements (GSPR) of the MDR and IVDR.
An EN ISO standard is an international standard that has been adopted at the level of the EU. The differences are outlined in the foreword and annexes to the EU document which make the link with EU requirements.
Get a copy of the slides from this webinar or click to watch the recording.
In this second part of our 2-part webinar series, Criterion Edge will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements. Presented from the perspective of seasoned regulatory writers with deep experience authoring MedDev rev. 4 and MDR-compliant CERs, this practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities. In this series, we will examine the Clinical Data Sources, Equivalence, and Risk/Benefit Analysis Profile sections of the CER.
In the first webinar of this series, we discussed the State of the Art, Safety & Performance Criteria, Equivalence, and Systematic Literature Review.
Click here to get the slides and watch the recording for part 1.
Key Takeaways:
• Understand the key components of a clinical evaluation report (1-min review of last webinar, clinical evidence, SLR, risk benefit, conclusion – have you ensured that your conclusion reflects conclusions from other sections/data?)
• Determine how to evaluate your CER for key requirements of the MDR
Who should watch this webinar?
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.
Sign up for future webinars here.
If you enjoyed this webinar and would like a free consultation, please contact us here.
Click here to watch the recording.
We had such a large turnout at our previous webinar, How to Assess Your CER for MDR Readiness, Part 1, and left with some questions unanswered. Therefore, President Laurie Mitchell held a live Q&A to respond to questions regarding CER for MDR Readiness. In this webinar, Laurie delves deeper into some of your pressing questions like:
Who should watch this webinar?
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.
Sign up for future webinars here.
If you enjoyed this webinar and would like a free consultation, please contact us here.
This white paper outlines strategies for the verification of device safety and performance as well as tips to define parameters to determine the acceptability of benefit-risk.
In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
This white paper is a companion piece to our popular webinar where we share our insights on using the Systematic
Literature Review (SLR) to Empower Data-Driven Decisions in your Organization.
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
In this webinar, Dr. Sarah Chavez provides an overview of the State of the Art section, and explains how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER) in a reasonable time frame. A complete readiness assessment and gap analysis will help you identify critical resources, feeder documents, and expertise needed to establish that your IVD may be considered “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.
This white paper is a companion piece to our popular webinar where we break down the steps of the systematic literature review (SLR) process and take a wholistic approach to conducting an In Vitro Diagnostic Regulation (IVDR)- compliant SLR.
This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it
fits into the In Vitro Diagnostic Regulation (IVDR).
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.
This white paper is a companion piece to our popular webinar where we share some of the best approaches we have
discovered for Corporate Scientific Communication Strategies.
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.
This white paper is a companion piece to our popular webinar that uncovers what we have learned from our experience in writing Medical Device Regulation (MDR)-compliant Clinical Evaluation Reports (CERs), and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
This white paper is a companion piece to our popular webinar where we share some of the biggest issues we have discovered when starting a Clinical Evaluation Report (CER) project, and how to anticipate and avoid project delays.
This companion piece to our popular webinar discusses strategies for assessing key components of your CER like clinical data sources and risk-benefit analysis.
This white paper outlines strategies to assess your CER including state of the art, safety and performance criteria, equivalence and systematic literature review.
Have the IVDR Performance Evaluation and Post Market Surveillance requirements got you tied up in knots? Where do you start? What does the end product look like? We are joined by the VP of Regulatory, Quality, and Clinical from Nextern, a collaborative medical device company bringing unmatched core competence in medical device product design and development. Criterion Edge’s President Laurie Mitchell will lead a discussion of their experiences supporting clients through MDR and IVDR requirements.
In this practical presentation, President Laurie Mitchell will: 1) discuss how an effective scientific communication plan is an important marketing tool for an organization, and 2) present five strategies to ensure your corporate objectives are supported and maximize the real-world impact of your data. Join us to learn how this applies to your organization and how to implement these strategies into your current processes.
In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER, needing more up-front planning than the reports have in the past. Based on our experiences with clients both large and small, our President, Laurie Mitchell, shares some of the biggest issues we have discovered when starting an MDR CER project. Laurie also reveals some of the most successful strategies in addressing these issues, up-front and early.
In this second installment of our 2-part webinar series, Criterion Edge shares practical presentation to help you assess your CER through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities.
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
Watch this video to learn how Criterion Edge is different from the rest.
This infographic goes through 5 key questions to go through in order to control your budget.
Leading industry experts come together to discuss how the MDR affects data management within their respective units.
This report clarifies the modifications to the equivalence guidelines in MEDDEV 2.7/1 and Quality Management Systems (QMS) ISO 13485 standard to help develop strategies.
This gap analysis addresses key revisions to evaluator qualifications and scientific validity in the Clinical Evaluation (CE) MEDDEV guideline rev.4.
The changes to 2.7/1 rev. 4 suggest the need to submit more frequent CERs to regulatory authorities, however, strategies will be discussed for managing the increased requirements.
Every time a healthcare provider makes a notation in the medical chart, a significant and valuable piece of data has been created. This paper discusses the implications of this.
This piece discusses 10 key strategies to building an efficient regulatory writing process.
In this paper, we discuss a prominent clarification on the MEDDEV 2.7.1 rev 4, establishing the “state of the art” section.
The overwhelming turnout at the ‘How to Assess Your CER for MDR Readiness, Part 1’ prompted us to host a live Q+A session where President Laurie Mitchell exclusively answers all your questions.
President Laurie Mitchell returns to continue sharing more about the importance of the systematic literature review.
Establishing and defining state of the art for a medical device is no longer an isolated task – it supports the entire Clinical Evaluation Report (CER). Multiple sections of the MEDDEV 2.7/1 rev 4 compliant CER need to be supported by state of the art data, including safety and performance, risk management, and equivalence.
In this first installment of a 2-part webinar series, Criterion Edge will present strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements.
In this webinar, President Laurie Mitchell discusses why safety reviews are essential in the entire life cycle of product development.
Kyoko Hattori from Criterion Edge returns to discuss best practices for managing the adjudication process in-house, and Brian Kelly from AG Mednet will share how the “JUDI” platform can simplify the management of adjudication.
In this webinar, learn about CECs, familiarization with regulatory guidance, decision factors leading to use of a CEC, and much more.
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