Graeme Ladds’ Post

🔍 Check Out the New MDCG 2024-3 Guide! The Medical Device Coordination Group (MDCG) has just released an insightful guide, MDCG 2024-3. This guide walks us through creating effective Clinical Investigation Plans (CIPs) for medical devices, which help ensure our work meets the highest standards. 📝 Highlights from the MDCG 2024-3 Guide: -             Content of the CIP: Detailed explanations are provided for each section required in a CIP, from general information, device identification, and description to detailed outlines of the clinical investigation's design, objectives, and statistical analysis plans. -             Benefit-Risk Analysis: The document emphasizes the importance of a thorough benefit-risk analysis, ensuring that the benefits to study subjects outweigh the risks. -             Compliance and Ethical Considerations: The guidance reinforces adherence to good clinical practice, ethical principles, and legal requirements, ensuring the protection of subject rights and well-being. -             Post-Investigation Follow-ups: Insights are offered on managing subjects post-participation, stressing the importance of continued care and monitoring, especially for devices intended to remain within subjects post-study. Curious to learn more?  Dive into the guide below. 👇

Learn more about the speakers at AAMI neXus 2024! More than 50 AAMI neXus speakers, including 24 from the FDA, have just been announced. More speakers will be added in the coming days, but the schedule is already jam-packed with experts addressing: - FDA’s new QSR, with perspectives from FDA and Industry on implementation - FDA Innovation Challenges relative to ethylene oxide (EO) sterilization - European Medical Device Regulations - Evolving MHRA Regulations - FDA’s Radiation Sterilization Master File Pilot Program - Updates on the now-permanent ASCA program - FDA’s Health Equity Priorities, including Diversity Action Plan requirements - FDA's Final Guidance on Remanufacturing of Medical Devices - EU and UK Check out the updated schedule and register now for the Inaugural AAMI neXus—a Global Event to Advance the Development, Adoption, and Application of Medical Device Standards! https://lnkd.in/eQmvmX9J

📢 𝗡𝗲𝘄 𝗧𝗚𝗔 𝗖𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝘁𝗶𝗼𝗻 𝗼𝗻 𝗣𝗿𝗼𝗽𝗼𝘀𝗲𝗱 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 𝘁𝗼 𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 𝘁𝗼 𝗔𝗹𝗶𝗴𝗻 𝘄𝗶𝘁𝗵 𝗘𝗨 𝗠𝗗𝗥! 𝟭𝟮 𝗔𝗨𝗚: The Therapeutic Goods Administration (TGA) has just released another consultation proposal document for feedback, this time on changes to the Australian Essential Principles (EP) for medical devices, to (mostly) align with the EU MDR General Safety & Performance Requirements (GSPR). See the TGA post below for details or go direct to the Consultation Portal here: https://lnkd.in/g32Cm6yG Consultation survey responses close on 𝟭𝟲 𝗢𝗰𝘁𝗼𝗯𝗲𝗿 𝟮𝟬𝟮𝟰. This is a meaty consultation (with a 108-page attachment!), and it is mostly a good step towards greater international harmonisation, but you don't have to respond to every single proposed change. 💾 If nothing else, 𝙥𝙡𝙚𝙖𝙨𝙚 consider responding to Proposal 13 (on page 18 of the consultation paper) which relates to the requirement under EP13B for the manufacturer to provide software version/build numbers to users of all devices that incorporate software (not just SaMD!). This requirement is unique to Australia and is 𝙣𝙤𝙩 aligned with the EU MDR GSPRs. Many manufacturers may not realise that it applies to a broader range of devices than they might think ... essentially anything with a microcontroller or microprocessor in it! 🔬 IVD manufacturers and sponsors may also wish to respond to Proposal 14 which would introduce a new requirement for Australian Sponsors of IVD devices to have written agreements in place with their manufacturer/s to ensure an appropriate level of technical assistance be available to Australian customers. #TGA #medicaldevices #consultation #haveyoursay #whereismydemocracysausage

thanks to Rolando, please see the next issue of OSI for an article from Rolando Toyos!

Excerpt from AAMI nexUS 2024 meeting where Dr. Shuren from the FDA spoke about Standards, and the ASCA effort. Acertara is the only FDA ASCA accredited laboratory for ultrasound testing. "Right now, the Accreditation Scheme for Conformity Assessment (ASCA) is an important opportunity for manufacturers. Dr. Shuren described ASCA as a “highly valuable program,” which is voluntary and meant to “leverage the international conformity assessment structure.” As of 2023, the program is permanent and relies heavily on voluntary consensus standards and functions as a “build out” of CDRH’s work with standards. Dr. Shuren touted ASCA’s benefits, such as dramatically reduced time needed for conformity assessment, certainty regarding what documentation is needed, and improved testing quality. So far, ASCA has enjoyed noteworthy success, and per Dr. Shuren, medical device sponsors are strongly encouraged to participate." 

📢 We’re seeking feedback on the proposed changes to the Australian Essential Principles for Safety and Performance of medical devices (Essential Principles), to align with changes being implemented in the European General Safety and Performance Requirements (GSPR). We are aiming to ensure the Essential Principles remain relevant and to identify opportunities for potential strengthening to improve safety and performance of medical devices. We are seeking your input on proposed alignment with the European GSPR from both the: • European Regulations 2017/745 on medical devices (MDR) • European Regulations 2017/746 for in vitro diagnostic medical devices (IVDR). Have your say using our online survey 👉 https://lnkd.in/gE799S9Z

🕝 Looking back over 2023 we have seen several changes released by the MDCG. In comparison to 2021, where we saw a very active year for MDCG releases, 2023 was a relatively steady year for updates and releases. 2023 saw: 🔹 7 new MDCGs published 🔹 7 MDCGs updated See the below link for the official list of MDCGs: #MDCG #medicaldevices #regulatoryaffairs #eumdr #Medtech #AuthorisedRepresentative

It’s halftime for #FBSIGNITE cohort 15. Here are my 3 key takeaways from the first 6 weeks working with the Pegasys Medical Team. #Fortive Fortive #FBS

📅 ECM attends the upcoming coordination meeting of notified bodies for medical devices Ente Certificazione Macchine - Medical Devices Division announces our participation in the 70th NBCG-Med meeting, taking place in Brussels 📍 from 9 to 11 April 2024! Follow us as we engage in crucial discussions surrounding the European regulatory landscape for medical devices with other Notified Bodies and stakeholders 🤝🔍 Don't miss out on our insights! Click on the link below to read our full article 👇 https://lnkd.in/d2_9VD9F #MedicalDevices #NBCGMed #MDR #RegulatoryCompliance #NotifiedBody

The IMDRF released an overview of the implementation status of all International Medical Device Regulators Forum (IMDRF) technical documents up until 30 August 2024. The document reflects IMDRF's mission of strategically accelerating international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices. 🔭 💡 The overview is organized by levels of implementation and by medical device regulators. Download the final document: https://hubs.li/Q02S3MKR0