Ensuring key standards for MDR and IVDR compliance are available for manufacturers is one of the top priorities for the European Commission after the summer break.
In this presentation we discuss strategies for the verification of device safety and performance in the clinical evaluation. Our seasoned CER medical writers are rooted in MDR-compliant practices. Likewise, this presentation will help you identify meaningful safety and performance measures for the clinical evaluation. In addition, we will define parameters to determine the acceptability of benefit-risk. Afterwards, we will have about 10-15 minutes to answer any questions you may have on this topic.
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve CERs for EU MDR submission. Anyone interested in learning more about MDR requirements for CERs is encouraged to come too. We encourage attendees from the IVD industry to attend as well, as the content is also relevant to IVDR requirements, which align closely with MDR.
All medical devices selling in Europe must have a Clinical Evaluation Report (CER). Specific and measurable safety and performance endpoints are paramount for an acceptable CER. However, many small medical device manufacturers are struggling to adequately define and subsequently document measurable safety and performance endpoints, especially in the literature review, to support an evidence-based evaluation.
The newest regulations for medical devices, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously, regulations under the old MDR and MEDDEV were not as demanding. Also, manufacturers are not accustomed to the current systematic process of CER evaluations. Read more on this topic in our recent blog post, here.
Want to read the highlights to verifying your device’s safety and performance? Download our white paper where we give your the best approaches to finding measurables objectives and acceptance criteria for your medical device.
Click here to watch the recording of this webinar.
There’s been plenty of discussion on the submission scope of current EU MDR and pending EU IVDR regulatory requirements for medical device manufactures. But what of organizational change management readiness? How should a medical device organization’s different business functions collaborate and align their people, processes, and knowledge to meet these regulatory requirements effectively and efficiently?
Watch the recorded webinar for a behind the scenes look at how one company is managing change within their organization. Dr. Imelda Omana-Zapata, BD Senior Manager Clinical Projects, will provide an overview of how she is planning and coordinating change within her organization to meet upcoming EU IVDR regulatory requirements. Laurie Mitchell, Founder and President of Criterion Edge, will discuss the critical technology and expertise required to meet more rigorous scientific validated submissions to notify bodies.
Key Takeaways:
Who Should Watch:
Who are the Panelists?
Laurie Mitchell, President | Criterion Edge
Dr. Imelda Omana-Zapata, Senior Manager, Clinical Projects | BD
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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Author: Suzanne Broussard, PhD | June 8, 2021
In vitro diagnostic (IVD) medical device manufacturers are scrambling to meet the In Vitro Diagnostic Regulation (IVDR) 2017/746 requirements imposed by the European Union (EU). Changes in IVD classification will require the majority of IVDs currently marketed in the EU to undergo notified body scrutiny under IVDR and obtain CE marking, yet few guidance documents have been released. Lessons learned from meeting Medical Device Regulation (MDR) 2017/745 can help pave the way.
Here we share our insights learned from writing many MDR-compliant Clinical Evaluation Reports (CERs) in the context of IVD medical devices and the looming IVDR deadline.
(more…)The EU has the green light to adopt and list standards that will be recognized under the MDR and IVDR. But there will be no escaping the impact of the delays, especially for the IVD sector.
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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