MDProject’s Post

🌟 𝗞𝗲𝘆 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗳𝗿𝗼𝗺 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗘𝘂𝗿𝗼𝗽𝗲'𝘀 𝟮𝟬𝟮𝟰 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗦𝘂𝗿𝘃𝗲𝘆 🌟 The MedTech Europe 2024 survey sheds light on the regulatory landscape for medical device and IVD manufacturers in Europe. The findings highlight both progress and ongoing challenges under the MDR/IVDR framework. Here's a quick summary: 🔹 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗣𝗲𝗿𝘀𝗶𝘀𝘁: Manufacturers report improvements in accessing Notified Bodies, but concerns about timelines, costs, and regulatory unpredictability remain significant barriers. 🔹 𝗖𝗼𝗻𝗳𝗼𝗿𝗺𝗶𝘁𝘆 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗕𝗼𝘁𝘁𝗹𝗲𝗻𝗲𝗰𝗸𝘀: A considerable portion of assessment time is consumed by pre-review and certificate issuance. Streamlining these phases could greatly enhance efficiency. 🔹 𝗥𝗶𝘀𝗶𝗻𝗴 𝗖𝗼𝘀𝘁𝘀: Expenses related to clinical evaluations, PMS, and certifications are climbing, with inconsistencies across Notified Bodies making financial planning harder for manufacturers. 🔹 𝗟𝗼𝗻𝗴-𝗧𝗲𝗿𝗺 𝗙𝗶𝗻𝗮𝗻𝗰𝗶𝗮𝗹 𝗜𝗺𝗽𝗮𝗰𝘁: By the end of a 5-year certification cycle, IVD manufacturers face up to a 70% cost increase, while medical device companies see a rise of around 50%. These findings underline the need for greater transparency, predictability, and cost-efficiency in Europe's regulatory framework to maintain innovation and competitiveness in the MedTech sector. 📖 Discover the full survey results and insights here: https://lnkd.in/eb-fdxqZ Let’s work together to address these challenges and foster a more sustainable future for MedTech innovation in Europe! #MedTech #MedicalDevices #IVD #MDR #IVDR #HealthcareInnovation #RegulatoryAffairs #MedTechEurope #Rephine

Navigating the Slow Transition: Key Insights on the Updated EU Medical Device Regulations and EUDAMED Implementation The 2017 EU regulations for medical devices and IVDs aimed to modernize the sector, enhance patient safety, and improve transparency. Despite the urgent need for updated oversight, the transition has been slow. Petra Zollner, Director of Regulatory Affairs at MedTech Europe, and Richard Houlihan, CEO of EirMed, discuss the ongoing challenges. Zoellner points out that the system remains "unpredictable, slow, complex, and unclear," impacting both large manufacturers and SMEs. The bottleneck in conformity assessments and delayed EUDAMED implementation have further complicated compliance efforts. Research shows that 54% of medical device manufacturers and 22% of IVD tests may be discontinued, with many companies prioritizing markets outside the EU. This impacts patient care, as clinicians report shortages of essential devices. The European Commission’s new proposal extends transition periods and mandates the gradual rollout of EUDAMED. While supportive, MedTech Europe emphasizes the need for improved efficiency and clearer timelines. Manufacturers must act now: prioritize EUDAMED compliance and communicate challenges to authorities. By staying informed and proactive, we can navigate these changes and continue to innovate within the EU market. https://lnkd.in/ebzhkHsE 📰 Stay ahead of the curve by following Practical Patient Care on LinkedIn for more industry news and insights. You can also access our latest edition here: https://lnkd.in/guUBWkRE #PracticalPatientCare #MedicalDevices #EUDAMED #IVDR #RegulatoryAffairs #HealthcareInnovation

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!

In-vitro diagnostic medical devices (IVDs) play a key role in the UK's healthcare system. As the IVD industry continues to advance rapidly, so does the future regulatory framework for medical devices. Currently, the MHRA is focused on delivering the future regulatory framework for medical devices. Some key achievements by the MHRA include: ➡️ Publication of the government response to the public consultation on the future regulation of medical devices in the United Kingdom. ➡️ The establishment of an Innovative Devices Access Pathway pilot. ➡️ Guidance on Software as a medical device ➡️ The laying of regulations for IVD devices in Northern Ireland to lay down proportionate penalties. Learn more: https://heyor.ca/1RDFOp #IVD #MedicalDevices #InVitroDiagnosticMedicalDevices

🌐 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

#PollResult Innovation in Medical Devices: The Role of Notified Bodies Innovation is central to most manufacturers’ strategies. Working with a Notified Body with a broad scope of designations and accreditations is one key success factor; this fosters confidence in innovation and optimizes the time to market for medical devices while minimizing change-associated risks. We recently asked you via LinkedIn about the percentage of codes covered by GMED under the MD and IVD regulations, and the majority of respondents found the right answer: 93%! We cover 65 out of 71 MDR codes and 80 out of 80 IVDR codes, which confers an extensive strategic advantage for manufacturers who trust us with their certification projects. #MDR #IVDR #MedicalDevices #Certification #RegulatoryCompliance

🌐 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

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!