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The European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. With this revision, the Commission aims to ensure patient care by improving the availability of these essential healthcare products. https://lnkd.in/erMfatbp #medtech #regulation #IVDR #medicaldevices | MedTech Europe

'The Commission will start its preparatory work for a targeted evaluation of the legislation on medical devices this year. The evaluation should assess how the legislation is affecting the availability of devices, in particular for devices with specific characteristics (e.g. paediatrics, orphan, innovative devices). In the assessment, special attention may also be given to costs and administrative burdens stemming from the implementation of legislation, especially for SMEs.' You would imagine they would do that assessment before preparing the regulation and not after they saw that companies do not have money to comply? Unfortunately one of the biggest myths for everyone working in health care and regulatory agencies is that if it is pharma or biotech company they have money. And while that may be true for big corporations the rest of the companies do not have these funds. #ivd #ivdr #medicaldevices

Invent Medical Corporation Receives the FDA 510(k) clearance for its HFT150® High Flow System Invent Medical Corporation is pleased to announce the FDA 510(k) clearance on their HFT150® high flow system. Sam Chang, CEO, comments, "After several years in development and based on multiple key opinion leaders' input on product design and features, we are launching the HFT150® high flow system, featuring patented proprietary platform technology into the USA hospital markets in the fall of 2024. Based on feedback from respiratory care practitioners and pulmonologists, we believe we have designed a world-class product that solves many of today's problems with current technologies in the high-flow market." A recent market report shows that the growth of the heated high-flow market sector is expected to outpace that of other respiratory devices. #inventrespiratory #highflowsystem #fdaclearance

The new IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2) document, released on April 26, 2024, outlines the global harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, ensuring clarity and consistency across the industry and the various regulatory jurisdictions. To read the key highlights and the full publication, click here: https://bit.ly/4a78YlY #IMDRF #IVD #RegulatoryUpdates

Update for the MedTech Industry! The European Commission has released new Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. 📜✨ This is a pivotal step in ensuring compliance and streamlining processes for all stakeholders in the diagnostics sector. Dive into the latest guidelines to stay ahead in the game and ensure your products meet the required standards. For more such updates visit omcmedical.com or contact us!! #MedTech #IVD #RegulationEU2017_746 #MedicalDevices #Compliance #HealthcareInnovation #EuropeanCommission #Diagnostics #QualityAssurance #RegulatoryAffairs #HealthcareRegulation #EURegulations #InVitroDiagnostics

Improperly sterilized #medicaldevices can pose a significant risk to patients. Read our blog, “Importance of #Microbiology Testing in Medical Devices,” to learn more about the growing market demand for #microbiologytesting and how Scapa Healthcare provides the expertise and suite of services required to help customers succeed. Read it here: https://lnkd.in/e3fv8vVu #sterilization #sterilisation #sterilitytesting

Breaking❗IVDR, EUDAMED and Supply News❗ Today, the European Commission is proposing to take additional steps: 1️⃣ to ensure the availability of in vitro diagnostics by allowing more time for manufacturers to transition to the new rules, subject to certain important conditions. 2️⃣ to enhance transparency and protect patient care by speeding up the launch of some parts of the European Database on Medical Devices – EUDAMED 3️⃣ to provide healthcare systems with more time to safeguard patient care by obliging manufacturers to notify in case of disruption of supply of certain medical devices and in vitro 👩🔬 IVDR: -> 31st December 2027 for class D devices -> 31st December 2028 for class C devices -> 31st December 2029 for class B and sterile class A devices Check the proposal: https://lnkd.in/eMtrxDVN Read the FactSheet: https://lnkd.in/ehR3DxPb Press Release: https://lnkd.in/e2b_Mtv3 Q&A: https://lnkd.in/epA9QaNK JOIN OUR DISCUSSION 25.01.2024 11h CET on our Discord Server. https://lnkd.in/g_7Z3Tgp + Follow us :-) #IVDR #EUDAMED #EUMDR #MedicalDevices #RegulatoryAffairs

💥Breaking: EUDAMED...Mandatory use of several modules could then start as early as Q4/2025💥 Commission proposal...#MDR #IVDR...as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices. Source: https://lnkd.in/dM4T_rrP #eudamed #medtech #medicaldevices #regulatoryaffairs #regulatorycompliance #EUDAMED 

Interesting update re: EUDAMED. Manufacturers should be actively working to achieve MDR certification, this is a reminder that the transition extension does not mean MDR work can stall or slow down. If you require any support in your transition to MDR then tranScrip can help. See our website for more details: https://lnkd.in/ereE2yyH #MDR #EUDAMED #medicaldevices

Improperly sterilized #medicaldevices can pose a significant risk to patients. Read our blog, “Importance of #Microbiology Testing in Medical Devices,” to learn more about the growing market demand for #microbiologytesting and how Scapa Healthcare provides the expertise and suite of services required to help customers succeed. Read it here: https://lnkd.in/e3fv8vVu #Sterilization #Sterilisation #SterilityTesting #MedicalDevice