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.
The European Commission is publicly recognizing the huge hurdles ahead for the IVD industry in complying with the IVD Regulation. Delaying the regulation has long been off its agenda, but it is struggling to find solutions.
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.
Over 70 guidance documents have been drafted to support MDR implementation. But there is confusion over whether guidance is legally binding, especially where it applies to notified bodies.
Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.
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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