Preeti Singh’s Post

Are you looking to access the European market with your IVD? Addressing Clinical Evidence early is crucial for navigating the new IVDR landscape. Often, gaps exist that require additional Clinical Evidence activities to ensure compliance. To help you gain a deeper understanding of these requirements, we've put together a whitepaper "Clinical Evidence for IVDs under the IVDR" 👇 https://lnkd.in/eA7hdu2A #IVDR #IVD #IVDD #ClinicalEvidence

✅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

The European Commission has published Guidance MDCG 2024-10 on the clinical evaluation of orphan medical devices. https://lnkd.in/dryaywhG Orphan devices are medical devices or their accessories, which are intended to be used for diseases or conditions affecting only a small number of individuals each year. Often, they are used to treat a rare disease or medical condition for which very few diagnostic or therapeutic options exist. Orphan devices can be crucial to fulfil an otherwise unmet medical need. The guidance provides criteria for determining when a medical device or an accessory for a medical device should be regarded as ‘orphan device’ under the Medical Devices Regulation 2017/745 (MDR). It aims to guide manufacturers and notified bodies when applying the MDR’s clinical evidence requirements and help overcome some of the challenges that lead to delays in patient access to orphan devices. The guidance includes the possibility for manufacturers and notified bodies to seek advice from European Medicines Agency expert panels on the orphan device status and the clinical data needed for their clinical evaluation. #MDR #clinicalevaluation #medicaldevices #EUMDR #medicaldevice

🚀 New MDCG guidance publication - MDCG 2024-10 🚀 It  provides crucial insights into the clinical evaluation of orphan medical devices.  Orphan medical devices cater to rare diseases, often with very few diagnostic or therapeutic options available. This guidance aims to balance the stringent requirements of the MDR with the unique challenges faced by orphan devices, ensuring timely patient access while maintaining high safety standards. 🔹 Key Highlights: 1. Orphan Device Status & Indications: Clarifications on criteria for orphan devices and the justification process. 2. Clinical Evaluation Considerations: Guidance on pre-market and post-market clinical data requirements. 3. Procedural Considerations: Enhanced roles for notified bodies and expert panels in ensuring the safety and efficacy of orphan devices. 📄 Read the full MDCG 2024-10 document here: #MedicalDevices #OrphanDevices #HealthcareInnovation #MDCG #EURegulations

Dive into our latest blog to explore the intricacies of Laboratory Developed Tests (LDT). These tests, created and used within individual labs, play a crucial role in personalized medicine and innovative diagnostics. Learn about their development process, validation, and the regulatory challenges they face. Discover how LDTs are advancing patient care by providing tailored diagnostic solutions. 🔗: https://lnkd.in/ezRBMCWG #LaboratoryDevelopedTests #LDT #PersonalizedMedicine #MedicalDevices #HealthcareInnovation

During January 2024, the document "Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)" was drafted and published. The document summarizes the intent of the EU Commission together with the MDCG, including relevant subgroups, with input from stakeholders to implement a joint action plan for the implementation of the implementing and directing rules of Regulation 746/2017 on in vitro diagnostic medical devices (IVDR)" The plan was drafted in the interest of patient safety with the goal is to ensure that the enhanced requirements of the new regulatory framework are implemented as soon as possible. The transition from the old directive to the new regulation is also a significant challenge for stakeholders, such as manufacturers, notified bodies, authorized representatives and healthcare institutions. Many of them are in advanced stages of preparing for compliance with the IVDR, engaging in activities such as reviewing documentation in line with the new requirements, hiring new staff and updating procedures.  In fact, the plan aimed to set goals for implementing the IVDR Regulations in the best way possible, while also hearing from stakeholders. Source: https://lnkd.in/eD3YBmiv #ivdr #mdcg #invitrodiagnostic #stakeholders #implementationandpreparednessplan #qualityassurance #regulatoryaffairs #vlfconsulting

The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2024-10, providing crucial insights into the clinical evaluation of orphan medical devices. These devices are designed to address rare diseases, which often have limited diagnostic or therapeutic options. The guidance aims to harmonize the stringent requirements of the Medical Device Regulation (MDR) with the unique challenges faced by orphan devices, ensuring patients have prompt access to these essential products while maintaining high safety standards. Read more about this in our latest publication 👉 https://lnkd.in/dSpw7iHU #Owlpharma #OwlNews #MDR #ClinicalEvaluation #OrphanMedicalDevices #News #Regulation

The Medical Device Coordination Group (MDCG) published guidance on July 25, 2024, for manufacturers and notified bodies on determining when a medical device or its accessory should be classified as an ‘orphan device’ under the Medical Devices Regulation 2017/745 (MDR) - https://lnkd.in/eJTezwxn. The guidance aims to help manufacturers and notified bodies apply the MDR’s clinical evidence requirements and address challenges that delay patient access to orphan devices. To qualify as an orphan device, manufacturers must show that the intended indication it treats is limited to conditions that afflict 12,000 people in the EU annually. Devices intended for subpopulations of larger disease groups can qualify if they meet this threshold. The MDCG states that devices treating rare diseases (affecting no more than 5 in 10,000 people in the EU) and used by no more than 12,000 individuals per year meet the criteria. Manufacturers and notified bodies can also seek advice from European Medicines Agency expert panels on orphan device status and necessary clinical data. If you need support regarding your medical device from one of our experts in the field, visit https://lnkd.in/eRRtRZcn. #MedicalDevice #MDR #EC #EMA #RegulatoryAffairs

We are pleased to announce the FDA has granted Fast Track designation to CB-010 in refractory systemic #lupus erythematosus and to CB-012 in relapsed or refractory #acutemyeloidleukemia. Both off-the-shelf #CARTcelltherapies are in clinical development to address unmet medical needs for patients with these serious conditions. Fast Track designation can help bring these therapies to patients faster. Learn more here: https://bit.ly/3TdZ8JM #BloodCancerAwarenessMonth #CRISPR #autoimmune

🌟 Exciting News! The FDA’s New Diversity Action Plans Guidance for Clinical Trials Are Here! We’ve eagerly awaited this moment for the past seven months, and it’s finally here! The FDA has released its long-anticipated guidance on Diversity, Equity, and Inclusion (DEI) in clinical trials, and Reveles Clinical couldn’t be more thrilled. At Reveles, we firmly believe that diverse and inclusive clinical trials are essential for ensuring that new therapies are safe and effective for all patient populations. This landmark guidance aligns perfectly with our mission to enhance patient engagement through innovative AI solutions and collaborative efforts with our sponsor partners. Why This Matters: Equity in Healthcare: The new guidelines will ensure that clinical trials better represent the diverse populations using the treatments. Improved Outcomes: Diverse participation can lead to more comprehensive data and better, more personalized healthcare solutions. Increased Trust: By prioritizing DEI, we can build greater trust within underrepresented communities, ensuring they feel valued and heard. We are excited to partner with our sponsors to turn these guidelines from insights into actionable strategies. Together, we will develop and implement practices that promote inclusivity and equity, ultimately enhancing the quality and reach of clinical research. Next Steps: Collaboration: We will work closely with our sponsor partners to integrate these DEI guidelines into all aspects of clinical trial design and execution. Education & Training: Providing ongoing education and training for our team and partners to ensure a deep understanding of DEI principles and their application. Technology & Innovation: Leveraging our cutting-edge AI technology to identify and overcome barriers to participation, ensuring a more inclusive approach to clinical trials. We invite our network to join us in this vital journey toward a more equitable future in clinical research. Together, we can make a difference, one trial at a time. Let’s move from insights to actions and create a lasting impact in the world of clinical trials. 🌍💪 #DEI #ClinicalTrials #FDA #Reveles #HealthcareInnovation #PatientEngagement #EquityInHealth