Greenlight Guru’s Post

IMDRF News! 📢 Today, on 25-June, the IMDRF released the final document on "In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)." Stay updated on the latest developments in the field of in vitro diagnostic devices! #IMDRF #IVD #RegulatorySubmission 🌐🔬

Understanding LDT Changes 🧪 Stay ahead of the game with our guide on FDA's proposed rule for LDTs. 💡 Learn how it affects IVD and Life Science companies. #IVD #LDT #FDA Download our guide -https://lnkd.in/eRREHj39

A recent FDA rule increases regulatory oversight of #LDTs and phases out the use of general enforcement discretion with respect to a significant number of LDTs over a four-year period. Dive into the details of the rule--and what it means for manufacturers of in vitro diagnostics marketed as LDTs--here: https://lnkd.in/eQ2adjif Caroline Williams, Mark Von Eisenburg, MS, Nancy El Hoyek, Laura T. Housman, MPH, MBA, DrPH(c), Brigit Kyei-Baffour, MBA #diagnostics #LDT #labdevelopedtest

Dr. Alberto Gutierrez will be co-chairing the “Regulatory Strategies for Point-of-Care Diagnostics Special Forum” at the 16th Annual Next Generation Dx Summit in Washington, DC on August 20th. The forum begins with a keynote presentation entitled “Updates on US FDA POC Test Regulations” presented by Timothy Stenzel, MD, PhD, Former Director, Office of in vitro Diagnostics and Radiological Health (FDA). A panel discussion entitled “Regulatory Strategies for Point-of-Care Diagnostics: Learning from Success Stories and Avoiding Pitfalls” and plenary fireside chat entitled “Laboratory-Developed Tests: Proposed Rule, Reclassification Activities, Potential Impact, and Path Forward” feature FDA regulators including Courtney H. Lias, PhD, Acting Director, OHT7: Office of in vitro Diagnostic Devices (FDA), and industry experts. Join the discussion to learn more about the essential components and nuances that are pivotal for regulatory approval for point-of-care diagnostics. #ndapartners #diagnostics #FDA #IVD #LDTs #laboratorydevelopedtests #NGDx #IVDR #regulatorysciences https://lnkd.in/d_z6tMBP.

#RegulatoryUpdatesWithRegDesk There is an important update from Northern Ireland. Submission and approval enabled the first application for in vitro diagnostic devices under the EU IVDR in Northern Ireland due to the recent implementation of a submission route for manufacturers of performance studies. Link: 👉 https://lnkd.in/eqPBR82d Follow: 👉RegDesk to get your Global Regulatory Updates! #RegDesk #compliance #topalerts #RegUpdates #RIM #NorthernIreland #UK #EUIVDR

The in vitro diagnostics (IVD) market is undergoing a major transformation driven by rising demand, technological advancements and the growth of multiplex disease testing. With the introduction of the E.U.'s IVDR, a new risk-based classification system brings regulatory oversight specifically for diagnostics, strengthening requirements for risk management and quality assurance while enforcing stricter rules for clinical evaluation, investigation and the use of hazardous substances. Discover how the IVDR sets the stage for global harmonization of IVD regulation. Download the report to learn more: https://lnkd.in/eQryXmhT #regulatory #IVD #InVitro #MedTech

🔍 𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: 𝐍𝐨𝐧-𝐂𝐄 𝐌𝐚𝐫𝐤𝐞𝐝 𝐈𝐕𝐃𝐬 𝐢𝐧 𝐄𝐔 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬    🚀 Join me at @RAPS Euro Convergence 2024 on May 8th, 10:25 CEST, as we explore the regulatory landscape for non-CE marked In Vitro Diagnostic tests in European clinical trials.    🧪 Along with @Dr. Pieter Bogaert, we will dive deep into the complex world of IVD tests that are critical for clinical trials yet face unique regulatory challenges. Our focus will be on devices used in performance studies under the European IVDR, including companion diagnostics and laboratory-developed tests.    📜 We'll discuss the responsibilities of laboratories and trial sponsors and provide a detailed overview of the regulatory requirements and documentation necessary for including these tests in clinical trials.    Feel free to connect with me here on LinkedIn to discuss more on regulatory strategies and innovation in diagnostics!    #IVD #RAPS2024 #OneEntourage #Entourage

Does your facility use lab-developed tests for diagnostics? The FDA says that future development of these tests will be subject to its approval, a major departure from previous regulations that put these tests under CLIA and CMS. What will this mean for your lab? The article below from MedPage Today gives more details. MedPage Today: https://lnkd.in/epTSDwYn #laboratorymedicine #MLT #LDT #FDA #CLIA #CMS

Available data shows that today a considerable number of in-vitro diagnostics currently on the market do not yet comply with In-Vitro Diagnostic Medical Devices Regulation (#IVDR) nor have been replaced by new devices. The situation is especially critical for high-risk IVDs. For that reason, the EU-Commission has recently proposed more time for companies to apply the #IVDR, under certain conditions: IVD-devices may be placed on the market or put into service ONLY IF the manufacturer or the authorized representative has lodged a formal application for conformity assessment with a NB (except with special approval) no later than: -  May 26th, 2025, for class D devices (only 13 months remaining) -  May 26th, 2026, for class C devices (just 25 months remaining) -  May 26th, 2027, for class B devices and for class A devices placed on the market in sterile condition. The later companies start updating their technical documentation or filing them with a NB, the higher the risk becomes to be NOT IVDR-ready by the corresponding due-date. Please feel invited to approach us directly during #RAPSEUConvergence or anytime to evaluate individual support-options. #OneEntourage #IVD #ConformityAssessment #ClinicalTrials

IVD device classification in Europe The CE Mark is required for all in vitro diagnostic