NAMSA’s Post

🔬 Exciting Developments in IVD Regulation! 🔍 MedTech Europe have acknowledged the European Commission's proposal for extending the In Vitro Diagnostic Medical Devices Regulation (IVDR) transitional periods and early mandatory use of the European medical devices database (EUDAMED) modules. MedTech Europe emphasizes the importance of this additional time for all stakeholders to identify and rectify issues, ensuring a seamless transition for manufacturers. The integrity of the EUDAMED database is highlighted as crucial for success. Four key conditions are outlined before making EUDAMED modules mandatory, emphasizing simplicity, EU-level management of device discontinuations, avoiding financial implications for manufacturers, and providing guidance for smooth implementation. As a recruiter involved in the IVD sector, I recognize the significance of these developments for our industry. It's a pivotal time, and discussions between stakeholders in 2024 will further drive lasting solutions, efficiency, innovation, and improved governance for the benefit of patients and European health systems. Let's continue to stay informed and engaged in the evolving landscape of IVD regulations! 💡🌐 #IVD #MedTech #RegulatoryUpdates #Healthcare #Diagnostics 

Acolad Life Sciences is excited to invite you to a groundbreaking webinar for medical device and IVD manufacturers: Global SSCP/SSP Implementation: Navigating the challenges, solutions, and best practices. This is an excellent opportunity for you and your organization to hear key technical insights that will help navigate the ever-evolving regulatory landscape with confidence. To secure your spot, simply click on the registration link below: https://lnkd.in/dJbdsbCa Date: 7 November 2023 Time: 10 am ET/16.00 CET Duration: Approximately 40 minutes Why should you attend? Acolad Life Sciences’ MDR-SME team, Nynne DeNiro and Stephane Millet, will review the current challenges, best practices, and insights gained through a survey conducted with medical device and IVD manufacturers, on the implementation of SSCPs and SSPs, based on EU MDR requirements. Based on the experience shared by industry peers, attendees will gain access to the survey results and actionable takeaways on how to best prepare and implement the new MDR deliverables, SSCPs and SSPs: ·            current SSCP/SSP implementation challenges ·            impact of delayed deadlines ·            organizational resources required ·            technology deployed to facilitate development ·            ongoing maintenance and change management ·            EU guidelines for format and readability Don't miss out on this informative webinar that promises to equip you with the knowledge and tools you need for successful global SSCP implementation. #translation #acolad #medicaldeviceregulation #rapsconvergence #sscp

EU Commission Proposes Transitional Provisions for Certain IVDs The European Commission unveiled a proposal addressing transitional provisions for select legacy in vitro diagnostic medical devices. This proposal extends additional time, under specific conditions, for manufacturers and notified bodies to finalize applications and conformity assessment procedures. Key Highlights: Ensuring Supply Continuity: Manufacturers are required to provide prior notice to competent authorities, relevant economic operators, and healthcare professionals/institutions in the event of supply disruptions of certain medical devices and in vitro diagnostics. Objective: The Commission aims to bolster patient care by enhancing the availability of vital healthcare products while upholding safety standards. The proposal addresses concerns over the transition of numerous IVDs to the IVDR ((EU) 2017/746) within current timelines. Transition Periods: Proposed IVDR transition periods vary based on device classification: Class D self-declared devices: Until December 31, 2027 Class C self-declared devices: Until December 31, 2028 Class B and A sterile devices: Until December 31, 2029 Legacy devices under IVD Directive (98/79/EC): May benefit from an extended transition period until December 31, 2027, subject to meeting specified conditions. Postponement: The application of a requirement for devices manufactured and used in health institutions is proposed to be postponed until May 26, 2030. 🔍 Note: This proposal is pending official publication in the Official Journal of the European Commission (OJEU). Current IVDR timelines remain effective but are subject to potential adjustments upon proposal implementation. Stay tuned for further updates as we navigate through these proposed changes to facilitate your transition process to the IVDR and amended timelines. #EUCommission #IVDs #HealthcareRegulations #MedicalDevices #HealthcareIndustry #EURegulations

🌟 The Crucial Role of Medical Device Distributors: Connecting the Dots in Healthcare! 🌟 Ever wondered about the role of a distributor in IVD laboratory diagnostic kits? Or the purpose of medical device companies? Let's explore the significance of medical device distributors and their contribution to the healthcare ecosystem. 📊 Role of Distributors in IVD Laboratory Diagnostic Kits: Distributors play a vital role in the supply chain of IVD laboratory diagnostic kits. They act as intermediaries between manufacturers and healthcare providers, ensuring seamless distribution and availability of these essential kits. They connect manufacturers' innovative products with medical laboratories, hospitals, and healthcare facilities. By providing timely access to accurate diagnostic tests, they contribute to early disease detection, effective treatment decisions, and patient care. 💡 Purpose of Medical Device Companies: Medical device companies serve a critical purpose in the healthcare industry. They design, develop, manufacture, and distribute a wide range of medical devices, including diagnostic equipment, surgical tools, monitoring devices, and more. These companies aim to improve patient outcomes, enhance healthcare delivery, and advance medical technologies through constant innovation and research. They collaborate with healthcare professionals and regulatory bodies to bring safe, effective, and efficient devices to the market. 🔗 #MedicalDeviceDistributors #HealthcareIndustry #IVD #PCRkits

Great post showing why medical devices should be treated the same way as drugs in the reimbursement process. Medical devices have had a differential treatment for some time (e.g. medical device tax), but with new approaches in neuromodulation having drug-like effects, we should now begin to think about reimbursement from targeting mechanisms regardless of modality -- to help patients faster receive the care they need (especially in Alzheimer's). Sinaptica Therapeutics is working on some amazing technology, and is a good place to invest if you have a passion to make an impact in Alzheimer's disease (some of the most remarkable data you will see using TMS/EEG and noninvasive approaches - Phase 2 placebo-controlled results that show our closed-loop neuromodulation therapy slows Alzheimer’s disease progression by >80% at 6 months, as measured by four different gold-standard cognitive & functional clinical trial endpoints). "Having spent nearly 20 years in the biotech industry, my current focus as a co-founder and president of a device company working on a breakthrough-designated precision neuromodulation system treating Alzheimer’s disease has taught me stark lessons on the differences between clinical development and regulatory process for devices versus drugs, but more importantly — and with greater impact — the differences between coverage and reimbursement. My experience on the latter differences was confirmed by a 2023 study published in JAMA Health Forum by researchers at Stanford University who showed that, in a selected sample of cleared medical devices based on novel technologies, it took an average of 5.7 years to achieve Medicare coverage. This is in contrast to published data showing that Medicare covers approximately 90% of newly approved drugs within one year of receiving FDA approval. These differences on coverage and reimbursement can limit access to the investor capital required to finance innovative devices through clearance and commercialization, as well as negatively affect the financial incentives to develop breakthrough devices." Thanks Rich Macary for writing this article and for shining light on this ever-present (and only growing) issue. https://lnkd.in/eRigkDmY

Ready for the reveal? 💡 Last week, we delved into an important topic – the communication of changes to notified information for in-house manufactured #IVDs. Let's now explore the prescribed timeframes for reporting, as laid out by Swissmedic. 🇨🇭 Link to the poll 👉 https://lnkd.in/eTqiGuQH According to the Article 10 of the Swiss In Vitro Diagnostic Medical Devices Ordinance #IvDO, healthcare institutions that manufacture and use in-house IVDs are required to notify Swissmedic before putting these products into operation. The notification should include the following details: 1️⃣ Their name and address. 2️⃣ The name and intended purpose of the IVD. 3️⃣ The risk class of the IVD. Additionally, any other relevant information related to these products should be provided to Swissmedic upon request. In the event of any changes to the information submitted, healthcare institutions must promptly communicate the changes to Swissmedic within 30 days. Are you interested in placing your medical devices or in vitro diagnostic medical devices #IVDs on the #Swissmarket and need assistance in navigating the regulatory requirements? Our team offers hands-on services! Please don't hesitate to get in touch with us ☞ meetus@taoexcellence.ch. #MedicalDevices #regulatoryaffairs #medtech #medtechindustry #invitrodiagnostics #timeframes #MedDO #IvDO #MSR #IVDR #compliance #Swissregulations #Patientsafety #healthcare 

📱📱📱DTx must mimic pharma commercialization in many respects to scale commercially! … 💊💊💊 DTx companies need to: - A distributed sales force - just like pharma - Presence at key clinical conferences- just like pharma - Publish clinical articles and papers - just like pharma - It takes about 12-14 visits from a sales rep to get an clinician to consistently prescribe the DTx - Own the relationships with the key clinician groups - Be part of the medical system, integrated with the systems and engaged closely with the clinicians - (If partnered with pharma to scale have your own specialist trainers to train their sales force and ensure they are specifically incentivized to sell the DTx) - (D2C probably not the way to go to make the big impact and create the big value… for DTx!) Great to hear about the scaling successes of Kranos Jens Noertershaeuser, Sympatient Kathrin Pfeiffer and Ariel Dora Stern #dtxberlin #dtx #dtxcommerciization Brain+ Health Tech Hub Copenhagen

EU IVDR News (Classification Rules) The Medical Device Coordination Group (MDCG) has published "MDCG 2020-16 rev.3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746" The primary purpose of this document is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union. It is also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution The main updates to this document from the previous revision include: • Addition of ‘kit’ definition • Revision of examples for Rule 3(a) and Rule 6 • Revision of Rule 4(a) and Rule 5(c) This document provides updates from the previous revision released in February 2023. #IVD #IVDR #invitrodiagnostic

Are you sure your сlinical trial won't fail due to poor #adherence?   Clinical trial failures from poor adherence aren't just costly, they delay critical medical advancements and impact patient lives. Ensure the success of your #trials by understanding the true cost of poor adherence and exploring MEMS AS solution that helps establish hard evidence for your trial's success. Discover more in our latest article: Clinical Trial Failures: Are We Counting the Cost of Poor Adherence?   https://lnkd.in/e4cRW8aF #ClinicalTrials #MEMSAS #PatientAdherence #AARDEXGroup

💡 Our latest blog delves into why clinical trials fail and the critical role of medication adherence. #ClinicalTrials #DrugDevelopment #Pharma #Research #Healthcare