BioMed Consulting & Training’s Post

Do you use the IMDRF document “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices”? If so, AAMI wants to hear from you! ISO Technical Committee 210, which works on quality management related to medical devices, is looking for feedback from regulatory professionals, academics, and industry insiders – these survey answers will be used by the Technical Committee to guide their future work. What’s in the survey? The ten-minute questionnaire looks at:  - Your familiarity with Essential Principles.  - Challenges associated with using the document.  - Other resources you find useful. #medicaldevices #IMDRF #MedTech https://lnkd.in/e5ysGtr6 

Are you interested in learning more about the basis of IVDR? Register for the webinar and learn more about classification of IVDs, the different requirements and the latest transitional timelines! Hope to see you there!

🚨𝗨𝗽𝗱𝗮𝘁𝗲𝗱 𝗠𝗗𝗖𝗚 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 🚨   The first Medical Device Coordination Group (MDCG) release of 2025 is already available, the update of guidance MDCG 2023-3: “𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟯-𝟯 𝗥𝗲𝘃. 𝟮 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746”.   MDCG 2023-3 Rev. 2 introduces the following minor updates: 🔹 𝗔𝗺𝗲𝗻𝗱𝗺𝗲𝗻𝘁 𝘁𝗼 𝗳𝗼𝗼𝘁𝗻𝗼𝘁𝗲 𝟴: update to align with Regulation (EU) 2024/1860, which amends Regulations (EU) 2017/745 and (EU) 2017/746. The updates address the gradual roll-out of Eudamed, the obligation to provide notification in the event of supply interruptions or discontinuation, and the transitional provisions applicable to certain in vitro diagnostic medical devices. 🔹 𝗔𝗺𝗲𝗻𝗱𝗺𝗲𝗻𝘁 𝘁𝗼 𝗩𝗚𝗟 𝗺𝗼𝗱𝘂𝗹𝗲 𝗺𝗲𝗻𝘁𝗶𝗼𝗻: the reference to the “‘Eudamed vigilance (VGL) module” has been revised to “Eudamed Postmarket surveillance and Vigilance module (VGL module)”.  🔹 𝗔𝗺𝗲𝗻𝗱𝗺𝗲𝗻𝘁 𝘁𝗼 𝗳𝗼𝗼𝘁𝗻𝗼𝘁𝗲 𝟯𝟰: The timeframe for manufacturers to receive comments on draft Field Safety Notices (FSN) has been clarified, changing from “48 working hours” to “48 hours (equivalent to two weekdays)”.    📄 For full details, refer to the complete guidance document below. 🔔 Stay tuned with 𝗥𝗲𝗽𝗵𝗶𝗻𝗲 for more MedTech regulatory updates this January!   #MedTech #MDR #IVDR #RegulatoryUpdates #Rephine

🌐 Global Harmonization in 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗟𝗮𝗯𝗲𝗹𝗶𝗻𝗴 IMDRF DOCUMENT: Principles of Labeling for Medical Devices and IVD Medical Devices - 26 April 2024 (Edition 2) SCOPE 🔎 this document applies to all medical devices, including IVDs, and provides comprehensive guidelines for the content and format of medical device labeling, whether in paper or electronic format. PURPOSE 🎯 the primary goal of this document is to establish globally harmonized principles for medical device labeling, by providing guidance on label content, instructions for use and patient information. Its implementation is expected to benefit Regulatory Authorities, Conformity Assessment Bodies, industry stakeholders, and end-users, by establishing consistent labeling requirements across jurisdictions and reducing country-specific variations. 🩺 Stay tuned for more updates as we continue to prioritize global harmonization and safety in medical device labeling! Download the full document 📑 https://lnkd.in/dWkWERBF #MedicalDevices #IVD #RegulatoryHarmonization #IMDRF #MDR

📢 Medical Devices Update: New Guidelines for Medical Device Labeling! 🌐 The International Medical Device Regulators Forum (IMDRF) has released a new document outlining the principles of labeling for medical devices, including those for in-vitro diagnostics (IVDs). 👉 This document aims to standardize the content and format of medical device labeling, which can be presented in paper or electronic form. It covers general labeling principles and includes specific sections on the label itself, instructions for use, and patient information. 👉 It's important to note that this document provides general guidelines and doesn't cover everything. Manufacturers should also consider the requirements of any relevant medical device or IVD medical device-specific standards. Additionally, advertising and promotional materials are not included in the scope of this document, and individual regulatory authorities may have their own requirements for these elements. 💡 This new guidance promotes clear and consistent labeling for medical devices worldwide, which can ultimately improve patient safety and device use. 🔎 Know more about our expertise for medical devices and IVDs labeling at: https://lnkd.in/dt4tQYNy #IVD #InVitroDiagnostic #RegulatoryAffairs #IVDR #EuropeanRegulations #RegulatoryCompliance #MedicalDevicesManufacturers #MedicalDevicesRegulatorySupportUnit #MDRu Sandra Balseiro Ana Brito Celeste Oliveira Natalia de Souza Lescura Raquel Gomes Viviana Gomes Luiz de Pádua Queiroz Júnior Ana Catarina Silva

🚀 **EU IVDR Update!** 🚀 The Medical Device Coordination Group (MDCG) published the revised "MDCG 2020-16 rev.3 Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746." This update offers essential guidance for manufacturers, notified bodies, and health institutions on IVD classification before market placement or service in the EU. Key revisions include adding a ‘kit’ definition, updated examples for Rule 3(a) and Rule 6, and revisions of Rule 4(a) and Rule 5(c). This document supersedes the previous version from February 2023. Stay informed on the latest regulatory changes! #IVDR #MedicalDevices #RegulationUpdate #MDCG #IVD2017/746 #compliance #healthtech

Level up your IVDR knowledge! This webinar provides essential knowledge on IVDR classification, conformity assessment, and the newest compliance updates. Register to gain valuable insights and stay ahead of the curve!

🌐 Join Our Medical Webinar: Navigating the IVDR Landscape - A Guide to Device Classification and Requirements 📅 Date: November 21, 2024 🕒 Time: 9:00 am and 3:00 pm CET 🎤 Speaker: Ellen van Loon, Technical File Reviewer for IVDR, DEKRA Are you a manufacturer preparing to navigate the IVDR CE marking process for in vitro diagnostic (IVD) devices? Join us for this informative medical webinar designed to guide you through the regulatory landscape of the IVDR. Key Topics: ✅ Device Classification: Learn the details of risk classification under the new IVDR regulation. ✅ Conformity Assessment: Explore the specific assessment requirements based on device classification. ✅ IVDR Transitional Period: Stay informed on the latest amendment impacting medical device compliance. Why Attend? This webinar will provide the basic knowledge needed to: ✅ Classify IVD devices and understand the regulatory implications. ✅ Prepare for necessary conformity assessments. ✅ Keep up-to-date on changes affecting medical device compliance. Who Should Attend? This session is ideal for manufacturers and startups working with IVD products. Sign up now for our free webinar: https://lnkd.in/eHmcXkmk #IVDR #IVDDevices #Compliance #CEMarking #MedicalDevices #MedicalDeviceRegulation #Webinar #IVDRRegulations

🌐 Join Our Medical Webinar: Navigating the IVDR Landscape - A Guide to Device Classification and Requirements 📅 Date: November 21, 2024 🕒 Time: 9:00 am and 3:00 pm CET 🎤 Speaker: Ellen van Loon, Technical File Reviewer for IVDR, DEKRA Are you a manufacturer preparing to navigate the IVDR CE marking process for in vitro diagnostic (IVD) devices? Join us for this informative medical webinar designed to guide you through the regulatory landscape of the IVDR. Key Topics: ✅ Device Classification: Learn the details of risk classification under the new IVDR regulation. ✅ Conformity Assessment: Explore the specific assessment requirements based on device classification. ✅ IVDR Transitional Period: Stay informed on the latest amendment impacting medical device compliance. Why Attend? This webinar will provide the basic knowledge needed to: ✅ Classify IVD devices and understand the regulatory implications. ✅ Prepare for necessary conformity assessments. ✅ Keep up-to-date on changes affecting medical device compliance. Who Should Attend? This session is ideal for manufacturers and startups working with IVD products. Sign up now for our free webinar: https://brnw.ch/21wOeyP #IVDR #IVDDevices #Compliance #CEMarking #MedicalDevices #MedicalDeviceRegulation #Webinar #IVDRRegulations

🌐 Register for Our Medical Webinar: Navigating the IVDR Landscape - A Guide to Device Classification and Requirements 📅 Date: November 21, 2024 🕒 Time: 9:00 am and 3:00 pm CET 🎤 Speaker: Ellen van Loon, Technical File Reviewer for IVDR, DEKRA Are you a manufacturer preparing to navigate the IVDR CE marking process for in vitro diagnostic (IVD) devices? Join us for this informative medical webinar designed to guide you through the regulatory landscape of the IVDR. 🔸Key Topics: ✅ Device Classification: Learn the details of risk classification under the new IVDR regulation. ✅ Conformity Assessment: Explore the specific assessment requirements based on device classification. ✅ IVDR Transitional Period: Stay informed on the latest amendment impacting medical device compliance. 🔸Why Attend? This webinar will provide the basic knowledge needed to: ✅ Classify IVD devices and understand the regulatory implications. ✅ Prepare for necessary conformity assessments. ✅ Keep up-to-date on changes affecting medical device compliance. 🔸Who Should Attend? ✅This session is ideal for manufacturers and startups working with IVD products. ✍️Sign up now for our free webinar: https://brnw.ch/21wOAQJ #IVDR #IVDDevices #Compliance #CEMarking #MedicalDevices #MedicalDeviceRegulation #Webinar #IVDRRegulations