DEKRA Digital & Product Solutions’ Post

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!

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://brnw.ch/21wOeyP #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://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/21wOreM #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/21wO1e0 #IVDR #IVDDevices #Compliance #CEMarking #MedicalDevices #MedicalDeviceRegulation #Webinar #IVDRRegulations

🌐 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

26 April 2024 Final Document IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices. Scope: The purpose of this IMDRF guidance is to provide harmonized Essential Principles that should be fulfilled in the design and manufacturing of medical devices and in vitro diagnostic (IVD) medical devices to ensure that they are safe and perform as intended. The worldwide adoption of a common set of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to, among others, manufacturers, users, patients/consumers, and to Regulatory Authorities. Reducing differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments. This document has been developed to encourage and support global convergence of regulatory systems. It is intended for use by Regulatory Authorities (RAs), Conformity Assessment Bodies (CABs), industry, and other stakeholders, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of medical devices in the interest of public health. It seeks to strike a balance between the responsibilities of RAs to safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens upon the industry #wyrobymedyczne #medicaldevices #mdr #ivdr #medtech #conformityassessment

Quick update to the post below, the anticipated Q&A document has been published by the European Commission. You can review the document here: https://lnkd.in/g5cRaht2 The 17-paged EXTENSION OF THE IVDR TRANSITIONAL PERIODS document is a "Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices". There is a helpful flowchart in the appendix that helps with understanding the conditions and deadlines for placing ‘legacy devices’ on the market or putting them into service in accordance with Article 110 IVDR, as amended by Regulation 2024/1860. Happy reading and, as always, don't hesitate to reach out to Beaufort CRO if we can be of help.

Are you prepared for the MDR transition deadline on 26 September 2024? The transition period for the Medical Device Regulation has been extended, but manufacturers must meet specific requirements with deadlines on 26 May 2024 and 26 September 2024 to benefit from this extension: 🔹 the devices 𝐜𝐨𝐧𝐭𝐢𝐧𝐮𝐞 𝐭𝐨 𝐜𝐨𝐦𝐩𝐥𝐲 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝐌𝐃𝐃, as applicable, 🔹 there are 𝐧𝐨 𝐬𝐢𝐠𝐧𝐢𝐟𝐢𝐜𝐚𝐧𝐭 𝐜𝐡𝐚𝐧𝐠𝐞𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐝𝐞𝐬𝐢𝐠𝐧 𝐚𝐧𝐝 𝐢𝐧𝐭𝐞𝐧𝐝𝐞𝐝 𝐩𝐮𝐫𝐩𝐨𝐬𝐞 of the devices, 🔹 the devices 𝐝𝐨 𝐧𝐨𝐭 𝐩𝐫𝐞𝐬𝐞𝐧𝐭 𝐚𝐧 𝐮𝐧𝐚𝐜𝐜𝐞𝐩𝐭𝐚𝐛𝐥𝐞 𝐫𝐢𝐬𝐤 to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health, 🔹 no later than 26 May 2024, the manufacturer has put in place 𝐚 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐬𝐲𝐬𝐭𝐞𝐦 𝐢𝐧 𝐚𝐜𝐜𝐨𝐫𝐝𝐚𝐧𝐜𝐞 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝐌𝐃𝐑, 🔹 no later than 26 May 2024, the manufacturer or the authorised representative has 𝐥𝐨𝐝𝐠𝐞𝐝 𝐚 𝐟𝐨𝐫𝐦𝐚𝐥 𝐚𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐰𝐢𝐭𝐡 𝐚 𝐧𝐨𝐭𝐢𝐟𝐢𝐞𝐝 𝐛𝐨𝐝𝐲 for conformity assessment in respect of the device or a device intended to substitute that device, and, no later than 26 September 2024, 𝐭𝐡𝐞 𝐧𝐨𝐭𝐢𝐟𝐢𝐞𝐝 𝐛𝐨𝐝𝐲 𝐚𝐧𝐝 𝐭𝐡𝐞 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞𝐫 𝐡𝐚𝐯𝐞 𝐬𝐢𝐠𝐧𝐞𝐝 𝐚 𝐰𝐫𝐢𝐭𝐭𝐞𝐧 𝐚𝐠𝐫𝐞𝐞𝐦𝐞𝐧𝐭. For detailed information about the MDR transition period, including insights on medical device and IVD class changes, read our blog ⬇ #medicaldevice #IVD #MDR #IVDR