MIDI Product Development’s Post

Part 2 coming soon! ICYMI, the third blog in our series, "The Overtures of Human Factors Guidance for U.S. Submission, Part 1: Origins and History," primes us for next week's blog "The Overtures of Human Factors Guidance for U.S. Submission, Part Two: Overview of U.S. and International Standards, General and Device Specific" The first half of this two-part exploration into how medical devices get the green light from the FDA, focused on human factors dove into the backstory of how regulations for medical devices came about, the rise of human factors engineering, and the folks who paved the way for today's standards. The upcoming second half will focus on understanding of the governing agencies and specific regulatory documents relevant to a particular device and an exact application of the practices and requirements they define. ICYMI, catch the first part here https://hubs.li/Q02wGqgS0 Stay tuned in the Innovation Vault for part 2 next week! #HFE #humanfactors #medicaldevices #medicaldevicedevelopment #FDA #blog

𝐀𝐫𝐭𝐢𝐜𝐥𝐞 𝟏𝟕 𝐨𝐟 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 (𝐄𝐔) 𝟐𝟎𝟏𝟕/𝟕𝟒𝟓 (𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 – 𝐌𝐃𝐑) 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐞𝐬 𝐭𝐡𝐞 𝐫𝐞𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐢𝐧𝐠 𝐨𝐟 𝐬𝐢𝐧𝐠𝐥𝐞-𝐮𝐬𝐞 𝐝𝐞𝐯𝐢𝐜𝐞𝐬 (𝐒𝐔𝐃𝐬) 📢 Interesting study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market. 💡 𝐀𝐫𝐭𝐢𝐜𝐥𝐞 𝟏𝟕 with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article. 💡This study evaluates how the provisions established in Article 17 MDR have been implemented and how such provisions function in practice. For this purpose, the current market situation for the reprocessing and reuse of SUDs was surveyed and analyzed across 30 European countries (EU-27 plus Iceland, Liechtenstein and Norway). 💡This report presents an overview of national decisions regarding the reprocessing of SUDs in the countries studied (ranging from permitted to prohibited to no decision taken at all). 💡The study also reports on the certification processes for SUDs by notified bodies, the reprocessing of SUDs by manufacturers and health institutions and the reuse of purchased reprocessed SUDs by health institutions. Perceived challenges and opportunities as well as actions recommended by stakeholders are included as well. 📢The report indicates 17 recommendations for optimizing the implementation of Article 17 MDR in Europe. Read full text: European Commission, European Health and Digital Executive Agency, Windisch, F., Zimmermann, N., Knoll, V. et al., Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market – Final report, Publications Office of the European Union, 2024, https://lnkd.in/dBxPcGqJ  #Medicaldevices #CEMARK #MDR #CEMARKING

🚀 Exploring Clinical Investigations Under MDR: Articles 62 and 63 Thrilled to have presented our poster on Articles 62 and 63 of the EU Medical Device Regulation (MDR 2017/745) during our class at Technological University of the Shannon . These articles delve into the requirements for clinical investigations, a cornerstone for demonstrating the safety and performance of medical devices. Key topics we covered: 📌 Article 62: The general requirements and ethical considerations for conducting clinical investigations in the EU. 📌 Article 63: Additional requirements when conducting investigations on vulnerable populations, emphasizing patient safety and informed consent. Our work highlighted the practical implications of these regulations, especially for companies aiming to ensure compliance while advancing innovation in medical technologies. We’d love to hear insights from professionals working with MDR regulations: - How have you navigated the challenges of clinical investigations under MDR? - Any best practices for ensuring compliance with Articles 62 and 63? A big thank you to our professor Orlagh Doyle and my colleague Altamash Shaikh . Looking forward to applying these learnings in real-world scenarios in the medical device industry! #MedicalDevices #EURegulations #MDR #ClinicalInvestigations #RegulatoryAffairs #StudentLife #PosterPresentation

The MDR, which came into full application in May 2021, has been a game-changer for Med Tech industry, bringing both challenges and opportunities. Key points to consider: 1. Stricter clinical evidence requirements: The bar for demonstrating device safety and performance has been raised significantly. 2. Enhanced post-market surveillance: Manufacturers must now implement more robust systems to monitor their devices in real-world use. 3. Unique Device Identification (UDI): This system is improving traceability and recall management, but implementation has been complex. 4. Notified Body capacity: The increased workload on Notified Bodies has led to bottlenecks in the certification process. 5. Software as a Medical Device (SaMD): The MDR has brought clearer guidelines for software classification and requirements. As we navigate these changes, it's crucial for manufacturers to stay informed and adapt their processes accordingly. The MDR's emphasis on patient safety and device effectiveness is pushing our industry towards greater innovation and accountability.

📍Exploring Annex XIII of the EU MDR: A Guide to Custom-Made Medical Devices This week's infographic dives into Annex XIII of the EU MDR, focusing on the specific requirements for custom-made medical devices. As you know, the MDR lays out a comprehensive framework for ensuring the safety and efficacy of medical devices across the European Union. Annex XIII plays a vital role in this process by addressing the unique considerations for custom-made devices, tailored to meet the specific needs of individual patients. 🔎What is Annex XIII and Why Does It Matter? Annex XIII mandates that manufacturers creating custom-made devices establish a detailed technical file encompassing critical aspects of the device. This file serves as a cornerstone for regulatory authorities, providing them with a clear understanding of the device's design, materials, intended purpose, and anticipated performance. It essentially acts as a comprehensive dossier for the custom-made device, ensuring its adherence to the MDR's stringent requirements. 📌Key Requirements of Annex XIII ✨Technical Documentation: Manufacturers must maintain thorough technical documentation detailing the design specifications, manufacturing procedures, materials used, and risk assessments conducted for the custom-made device. ✨Performance Evaluation: The annex emphasizes the importance of evaluating the device's performance against predetermined criteria to ensure it meets the specific needs of the intended patient. ✨Post-Market Surveillance: Manufacturers are obligated to maintain a post-market surveillance system to continuously monitor the device's performance and identify any emerging safety concerns. Stay tuned for upcoming infographics on other Annexes of the EU MDR! #EUMDR #MedicalDevices #CustomMadeDevices #RegulatoryAffairs #MedicalDeviceCompliance 📯Call to Action: * Share your thoughts! Have you had any experiences with custom-made medical devices? Leave a comment below and share your insights. * Stay connected! Follow me for upcoming infographics on other MDR Annexes. * Let's discuss! Feel free to connect with me to explore this topic further.

Attention all medical device innovators and compliance enthusiasts! 📢 Our very own Vik Chandna dives deep into the emerging standards and regulations that are shaping the future of medical devices in his latest blog post on InCompliance Magazine. If you're navigating the complexities of regulatory compliance or just want to stay ahead of the curve, this is a must-read. 💡 🔗 Read the full article here: Emerging Standards and Regulations for Medical Devices https://lnkd.in/g_GDaw2X Curious to hear your thoughts – which emerging trend do you find the most challenging or exciting? Let's discuss! 💬 #MedicalDevices #Compliance #Innovation

How are suppliers coping with the medical device sector’s surging regulatory burden? Life Sciences Voice asks Peter Muller & Mike Baird of Schlafender Hase here https://bit.ly/4h9Uve3. With reference to new research, they are considering how well Class 2 and 3 device manufacturers are adapting. #medicaldevice #regulatoryrequirements #elabelling #FHIR

How are suppliers coping with the medical device sector’s surging regulatory burden? Life Sciences Voice asks Peter Muller & Mike Baird of Schlafender Hase here https://bit.ly/4h9Uve3. With reference to new research, they are considering how well Class 2 and 3 device manufacturers are adapting. #medicaldevice #regulatoryrequirements #elabelling #FHIR

𝗧𝗵𝗲 𝗙𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗔𝗜 𝗶𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀: 𝗞𝗲𝘆 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙/𝗔𝗜𝗪𝗚/𝗡𝟳𝟯 𝗗𝗿𝗮𝗳𝘁 This document outlines ten key principles that are essential for developing safe, effective, and high-quality AI-enabled medical devices. At 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗦𝘆𝘀𝘁𝗲𝗺𝘀 𝗖𝗼𝗻𝘀𝘂𝗹𝘁 (medicalsysconsult.com), we have a deep understanding of the regulatory landscape for AI in medical devices. We can help clients navigate the complex regulatory requirements and develop a comprehensive regulatory strategy. 𝗛𝗲𝗿𝗲 𝗮𝗿𝗲 𝘀𝗼𝗺𝗲 𝗼𝗳 𝘁𝗵𝗲 𝘄𝗮𝘆𝘀 𝘄𝗲 𝗰𝗮𝗻 𝗵𝗲𝗹𝗽: * Develop a regulatory roadmap for your AI-enabled medical device. * Identify and mitigate potential regulatory risks. * Prepare regulatory submissions. * Provide ongoing regulatory support. Contact Medical Systems Consult today to learn more about how we can help you bring your AI-enabled medical device to market. 𝘼 𝙛𝙚𝙬 𝙠𝙚𝙮 𝙥𝙤𝙞𝙣𝙩𝙨: * The GMLP principles outlined in the IMDRF/AIWG/N73 Draft are likely to be adopted by regulators around the world. * Companies developing AI-enabled medical devices should start to implement these principles now. * Medical Systems Consult can help companies develop and implement a GMLP-compliant development process. * The use of AI in medical devices is expected to grow rapidly in the coming years. 𝙋𝙤𝙨𝙨𝙞𝙗𝙡𝙚 𝙍𝙞𝙨𝙠𝙨 * Companies that do not comply with GMLP principles may face regulatory delays or even product recalls. * AI-enabled medical devices that are not safe or effective could harm patients. * The use of AI in medical devices raises ethical concerns that need to be addressed. Medical Systems Consult can help companies navigate the complex regulatory landscape, stay ahead of the curve, and ensure that their AI-enabled medical devices are safe, effective, and compliant with regulations. www.medicalsysconsult.com