Matrix Requirements’ Post

✅Interesting Fact About the In Vitro Diagnostic Regulation (IVDR) Did you know the IVDR (EU 2017/746) introduces stricter safety and performance standards for in vitro diagnostic devices? It also mandates robust clinical evidence and a centralized database for transparency. These changes highlight the need for expert regulatory support and services! To better understand your expectations and needs, we’ve created a short questionnaire. Your feedback will help us provide the most efficient and effective regulatory support possible. 👉 https://lnkd.in/eQF9y8Jz Your insights are invaluable. How can we best support your journey through the IVDR? #MedicalDevice #IVDR #Regulatoryconsultancy #HealthCare #IVD #clinicalEvidence #invitrodiagnostic

Are you ready to unlock the secrets to successful IVDR CE-mark submissions? Join us for an exclusive webinar that will give you the edge you need: "Ask The Expert: IVDR - Early Experience and Feedback." The In Vitro Diagnostic Regulation (IVDR) is transforming the landscape of diagnostic devices, and we're bringing you the insights you need to thrive in this new era. Our webinar is your golden ticket to understanding the ins and outs of IVDR and hearing from seasoned professionals who've navigated its early stages. Reserve your spot today, and be part of this vital conversation. https://lnkd.in/gda_s6T6 #IVDR #CEMark #DiagnosticDevices #Webinar #IVDRCompliance #MedicalDevices #RegulatoryCompliance #ExpertInsights

25/04/2024 - "The Commission welcomes the adoption by the European Parliament today of measures, proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics (IVDs) for patients and healthcare providers. These measures include granting more time to companies to transition to the new EU rules on IVDs, introducing a new obligation on manufacturers to inform national authorities and the health sector in case of disruption of supply of certain medical devices and allowing for the gradual roll-out of the European Database on Medical Devices - Eudamed. The measures give more time to consider possible actions to safeguard patient care in instances where certain devices are discontinued and increase transparency regarding medical devices on the market." Fonte https://lnkd.in/dsQm2Zfd #IVD #IVDR #MedicalConsulting

Great piece of information regarding Medical devices. Now that there is more awareness around the Globe for the Medical Devices, here is a guidance from MDCG regarding evaluation of Orphan Devices. #MedicalDevices #MDCG #PatientSafetyFirst

📣 Regulatory News: Swissmedic releases revised MedDO and IvDO On September 29, 2023, the new requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro diagnostic medical devices was published. For the full report & resource, visit https://hubs.ly/Q025wBSh0 and subscribe for regular update notifications! 🇨🇭 Are you looking for information on product registration in Switzerland? Our regulatory experts keep you informed at https://hubs.ly/Q025wz5Z0. #ArazyGroup #RegulatoryAffairs #RegTech #RegTechAI #AccessibleInformation #SwissmedicUpdate

Breaking❗IVDR, EUDAMED and Supply News❗ Today, the European Commission is proposing to take additional steps: 1️⃣ to ensure the availability of in vitro diagnostics by allowing more time for manufacturers to transition to the new rules, subject to certain important conditions. 2️⃣ to enhance transparency and protect patient care by speeding up the launch of some parts of the European Database on Medical Devices – EUDAMED 3️⃣ to provide healthcare systems with more time to safeguard patient care by obliging manufacturers to notify in case of disruption of supply of certain medical devices and in vitro 👩🔬 IVDR: -> 31st December 2027 for class D devices -> 31st December 2028 for class C devices -> 31st December 2029 for class B and sterile class A devices Check the proposal: https://lnkd.in/eMtrxDVN Read the FactSheet: https://lnkd.in/ehR3DxPb Press Release: https://lnkd.in/e2b_Mtv3 Q&A: https://lnkd.in/epA9QaNK JOIN OUR DISCUSSION 25.01.2024 11h CET on our Discord Server. https://lnkd.in/g_7Z3Tgp + Follow me :-) #IVDR #EUDAMED #EUMDR #MedicalDevices #RegulatoryAffairs

We must adapt traditional clinical trial designs to accommodate the unique features of DTx and prove clinical efficacy. In this masterclass, David Benshoof Klein and Shaheen E Lakhan, will teach us how while also looking at innovative and effective strategies to implement in your trials. They’ll discuss how to: 💬 Choose the right study design and comparators for your DTx 💬 Determine the appropriate placebo controls for the trial 💬 Align your clinical trial design with your product development timelines 💬 Select the relevant endpoints and outcomes for your DTx Only a few seats left - apply now ➡️ https://lnkd.in/eHhV8Zy2 #DTx #clinicaltrials #digitalhealth

The #FDA has finalised its rule on laboratory developed tests (#LDTs), marking a significant shift in medical diagnostics regulation. Discover the key changes and implications for the industry in our latest blog post. PeploBio's regulatory experts are here to guide you through this transition and ensure compliance. Learn more: https://lnkd.in/eZs24r_8 #FDARegulation #MedicalDiagnostics #LDTs #RegulatoryCompliance #HealthcareIndustry #Diagnostics #MedicalDevices #FDAApproval #LabTesting #ComplianceSupport

📣 Regulatory News: Swissmedic releases revised MedDO and IvDO On September 29, 2023, the new requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro diagnostic medical devices was published. For the full report & resource, visit https://hubs.ly/Q025wC9M0 and subscribe for regular update notifications! 🇨🇭 Are you looking for information on product registration in Switzerland? Our regulatory experts keep you informed at https://hubs.ly/Q025wy4N0. #ArazyGroup #RegulatoryAffairs #RegTech #RegTechAI #AccessibleInformation #SwissmedicUpdate

Breaking: Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply. "This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions.  Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs." #medicaldevices #invitrodiagnostics #medtech #EUMDR #EUIVDR #EUDAMED #supplychainmanagement