TÜV SÜD - Healthcare & Medical Devices’ Post

🩺 Under the MDR, it is crucial to review and update the classification of medical devices. Misclassifications can lead to delays, but TÜV SÜD is here to help! Our expedited services and Structured Dialogues ensure fast market access and compliance. 👉 Don’t wait, act now! https://lnkd.in/eRzkf6uz 📅 Book a meeting with us today to discuss your questions regarding risk classification requirements: https://lnkd.in/emysRmT2

🩺 Under the MDR, it is crucial to review and update the classification of medical devices. Misclassifications can lead to delays, but TÜV SÜD is here to help! Our expedited services and Structured Dialogues ensure fast market access and compliance. 👉 Don’t wait, act now! https://lnkd.in/dr8YbS73 📅 Book a meeting with us today to discuss your questions regarding risk classification requirements: https://lnkd.in/dA9UZGz8

📣 The "Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 31 October 2023) - Revised version 11 March 2024" was published this week. The study aims to support monitoring and analysing the availability of medical devices on the EU market in the context of the implementation of MDR/IVDR from the perspective of key stakeholders. 🔗 Link to the document here: https://lnkd.in/e3Hm85mb #medicaldevices #eumdr #notifiedbody

🔊 Notified Bodies Survey on MDR and IVDR certifications In February 2024, the European Commission published the results of the sixth survey conducted until October 2023 on MDR and IVDR certifications and applications. As of October 2023, there were 41 notified bodies designated under the Regulations. 🗓 As in previous surveys, this document includes answers from all notified bodies. Such surveys are essential to understand the transition status of devices to foresee and prevent market disruptions of medical devices. 🔗 Want to know more about the topic? Have a look at our brand new article -> https://lnkd.in/eFm8mkf3 #mdr #ivdr #europeancommission

🔍 Need clarity on EU MDR and device equivalence? Our latest blog post and upcoming webinar shed light on MDCG 2023-7 — the guidance offers new clinical evidence pathways for Class III and implantable devices. Read the blog to learn how the guidance can streamline your compliance process: https://hubs.ly/Q02kry9l0 #MDR #MDCG #RQMplus #MedTech #MedicalDevices #MedTechInnovation

⏳Don't miss our LIVE Webinar: "Countdown to May 26, 2024: Navigating MDR's Legacy Device Deadline" on Wednesday, May 15, 2024, from 4:00 PM to 5:00 PM (UTC+02:00). 🔹 Learn about the legacy period for medical devices certified under previous directives 🔹 Understand the new extension period and derogation process 🔹 Explore the application in the EU and Switzerland This webinar is crucial for ensuring compliance with the upcoming MDR deadline. Register now to secure your spot -> https://lnkd.in/eefrmc-e Davide Turchi Eric Klasen #MDR #MedicalDevices #RegulatoryCompliance #Webinar 🚀

📣 Attention Medical Device Manufacturers in the EU! Streamline your device registration process with My Basic UDI-DI Manager. Assigning Unique Device Identifiers (UDI) to your products can be complex, but with My Basic UDI-DI Manager, it's a breeze. What you will learn: ✅ Register and maintain your Basic UDI-DI, UDI-DI, and legacy devices easily ✅ Ensure compliance with EU regulations ✅ Simplify your data collection and registration for EUDAMED Join the webinar: • 19 September at 1pm in French • 26 September at 1pm in Dutch • 24 September at 1pm in English Take the first step today and revolutionize your device registration process. 📈 Register now > https://bit.ly/3KVu3pu #MedicalDevice #DeviceRegistration #EUCompliance #StreamlineProcess #MyBasicUDIDIManager

The Medical Device Regulation (#MDR) is currently a work in progress. Changes occur regularly, and stakeholders have to adapt accordingly. As expected, the MDR has not been standing still recently. That is why we have put together an action plan for you in addition to the latest information, showing you what steps you need to take now. On January 23rd, for example, the European Commission proposed a gradual roll-out of the #EUDAMED. The proposal received an endorsement by the European Council on February 21st. Furthermore, there is some news about the notified bodies. Read our latest article to find out what the gradual obligation means and what news there is about the #notifiedbodies. https://lnkd.in/eN5jwgAE

𝗔𝗰𝗰𝗼𝗿𝗱𝗶𝗻𝗴 𝘁𝗼 𝗺𝗼𝘀𝘁 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀, 𝘁𝗵𝗲 𝗻𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗯𝗼𝗱𝘆 𝗰𝗼𝗻𝗳𝗼𝗿𝗺𝗶𝘁𝘆 𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗶𝘀 𝘁𝗵𝗲 𝗺𝗼𝘀𝘁 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗶𝗻𝗴 𝗽𝗮𝗿𝘁 𝗼𝗳 𝘁𝗵𝗲 #𝗖𝗘𝗺𝗮𝗿𝗸𝗶𝗻𝗴 𝗽𝗿𝗼𝗰𝗲𝘀𝘀.    Our #EUMDR expert Pontus Gedda outlined the conformity assessment procedure in this flow chart to help you navigate.    🎓 This topic is part of our online course Introduction to the Medical Device Regulation (EU) 2017/745 https://bit.ly/3Y4MMqt which covers an orientation of the MDR and related guidance documents such as the MDCG and how to apply for a conformity assessment. ▶ Watch Pontus’ explanation of conformity assessment procedures for medical device manufacturers in this short video: https://lnkd.in/dDCXwXF9    #MedicalDevices  #QualityAssurance 

We untangled the economic operators, their tasks and the flow of information... ... to bring clarity to article 25 of the MDR 2017/745 👇 From the manufacturer to the user, the flow of information is thinned to the labeling. The label and the IFU, with potentially additional information depending on the nature of the medical device, are the only things the user receives as information. Over the chain of custody of a medical device, the information from the manufacturer over each economic operator is provided "downstream". See here the parts missed per each economic operator up to the user. #avantieurope #MDR #supplychain #medicaldevices