MedTech Europe’s Post

Document Depot captured a total of 153 medtech #policy documents from July through September (see infographic below). Of those, 17 (a bit over 10%) primarily address clinical data/study requirements, either broadly or for specific categories of devices. This doesn’t include guidelines outlining general #regulatory review expectations for device types that might include clinical requirements or other documents that address clinical data incidentally under a broader theme. Here is a look at some of the more significant recent items delivering #medtech clinical insights, from China, the US, and Europe: https://bit.ly/3YLtXsg

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Last week, my colleagues, Sara Ramió Pujol and Irati Mendia Azkoaga, hosted #AliraHealth latest webinar on navigating the complex #Regulatory landscape for #Medtech in both the EU and the US. During the session, we asked the audience: "On average, how long is it taking you to register a product?" ➡ The most frequent response was: 2-5 years. On October 30th, the European Commission released the latest findings from the #NotifiedBodies Survey, which aligns with the results we saw in our poll and exemplifies the challenges discussed during the webinar to achieve MDR/IVDR certification. Notably, the survey also revealed a high rate of certification refusals, highlighting the ongoing hurdles faced by the Medtech industry (https://shorturl.at/EVsiH) ➡If you missed our webinar, you can watch it now to help guide your regulatory strategy: https://lnkd.in/g3KD3BRX At #AliraHealth, we’re here to support you in tackling these regulatory challenges, from defining your strategy, building the technical documentation to implemening your QMS. #Regulatory #Medtech #MedicalDevices #NB #NotifiedBodies #MDR #IVDR

𝐂𝐞𝐧𝐭𝐫𝐚𝐥𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐢𝐧 𝐌𝐞𝐝𝐭𝐞𝐜𝐡 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧—𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐟𝐫𝐨𝐦 𝐆𝐞𝐫𝐭 𝐁𝐨𝐬 𝐢𝐧 Amanda Maxwell'𝐬 𝐋𝐚𝐭𝐞𝐬𝐭 𝐀𝐫𝐭𝐢𝐜𝐥𝐞. "One rule to rule them all." This powerful statement from Gert Bos, PhD, FRAPS underscores the growing call for greater centralization in EU MedTech regulation. In Amanda Maxwell's insightful article, published by Medtech Insight, Bos and Sabina Hoekstra-van den Bosch, PharmD FRAPS, discuss the challenges and opportunities of centralization. While not a "silver bullet," centralization could provide much-needed consistency in critical areas such as risk classification, borderline decisions, and orphan device approvals. Bos emphasizes the need for practical implementation strategies and harmonized interpretations across notified bodies to truly address the MDR's complexities. Curious to dive deeper into these critical discussions? Read Amanda Maxwell's full article here: https://lnkd.in/grrKGRah. We’d love to hear your thoughts! What’s your take on the future of centralized governance in medtech regulation? #MedTech #EURegulations #MDR #Qserve #HealthcareInnovation

📢 𝗘𝗨𝗗𝗔𝗠𝗘𝗗 𝗡𝗘𝗪𝗦: 𝗚𝗿𝗮𝗱𝘂𝗮𝗹 𝗶𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗘𝗨𝗗𝗔𝗠𝗘𝗗 👉 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟮𝟰/𝟭𝟴𝟲𝟬 brings great news: the gradual implementation of electronic systems integrated into the European database of medical devices (Eudamed). 👉 Now, finalised systems can be used immediately, without waiting for all six modules to be completed. 👉 𝗠𝗮𝗶𝗻 𝗯𝗲𝗻𝗲𝗳𝗶𝘁𝘀: ✅ Transparency: Increases the visibility of information about devices on the EU market. ✅ Monitoring: Facilitates the tracking of device availability. ✅ Registration: Systems for registering economic operators, devices and certificates are already in place. 🤝 For more details, see the 𝗤&𝗔 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗼𝗻 𝘁𝗵𝗲 𝗴𝗿𝗮𝗱𝘂𝗮𝗹 𝗶𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗘𝘂𝗱𝗮𝗺𝗲𝗱 below. 🔎 Find out more about how Smart MDR can help your company stay up to date with EUDAMED at www.smartmdr.com #EUDAMED #Regulation #MedicalDevices #Transparency #Innovation Sandra Balseiro Celeste Oliveira Natalia de Souza Lescura Viviana Gomes Luiz de Pádua Queiroz Júnior

Evaluating MDR, Last Gasp in Congress, Australia UDIs, and More   In this week’s Pathways Picks: The European Commission launches a targeted evaluation of medtech regulations, notified bodies outline how device companies should seek MDR certification, and more EU updates; members of Congress plan to approve a funding bill that includes an array of healthcare reforms, and issue a report on AI; Australia drafts a UDI guidance; and more from the US, UK, and South Africa. Get your picks here: https://bit.ly/4gkAqAH #medtech #innovation #regulatory #notifiedbodies

What are 3 benefits you get from reading a Digital Edition of Market Pathways, the #medtech industry's only strategic publication focused on regulatory, reimbursement, and policy affairs: • Stay informed on current information on regulatory changes and trends, helping readers stay informed about the latest requirements and guidelines • Get information #reimbursement policies and strategies, aiding companies in navigating the complex reimbursement landscape.  • Receive in-depth analysis of policy developments and their implications for the medtech industry. Here's what to expect in the most recent June 2024 Digital Edition: • Fixing MDR: we speak with Erik Vollebregt, who drafted the comprehensive revisions now proposed by German MEP Peter Liese, aimed at solving the challenges that have reversed the tide of European device innovation • Upcoming CMS payment rule proposals could improve reimbursement for AI-based healthcare tools and digital therapeutics • Our roundup of recent global #policymaking • In Consultants Corner, Elisabeth George on putting standards to work for medtech Let us know in the comments: do you prefer to read online or in print?

Curious how custom-made medical devices are driving innovation across Europe? Discover how tailored solutions are reshaping the healthcare landscape, addressing unique patient needs, and aligning with stringent EU regulations. Explore the blog to learn more about Regulatory frameworks and future trends that will impact both manufacturers and patients. Read more here: https://shorturl.at/nGrWN #HealthcareInnovation #CustomMedicalDevices #EUMedicalRegulations #MedicalDeviceTrends #PatientCentricCare

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In our last webinar on “Developing an Effective Regulatory Strategy for the Evolving 2024 Medtech Landscape” we asked attendees: “What’s the most important factor in building a regulatory strategy?” Although all the answers were correct, the poll underscores a critical trend – MedTech companies increasingly need to master unique regulatory requirements across markets. The #Regulatory #MedTech Department of Alira Health can support you in this regulatory challenge to bring a product to market successfully. If you missed our webinar, you can watch it now to help guide your MedTech regulatory strategy: https://lnkd.in/g3KD3BRX