Diaceutics PLC’s Post

Understanding a market's regulatory landscape can lead to informed strategies and commercialization success! To learn more, join our webinar on September 5th, 1-2pm EDT... https://lnkd.in/ep--Jn6f #PrecisionMedicine #Regulations #IVDR #LDT #Diagnostics #Webinar

🚀 **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

❗ IVDR and Eudamed News ❗ We are pleased to announce the official publication of Regulation (EU) 2024/1860 in the Official Journal of the European Union. This crucial regulation outlines important updates regarding EUDAMED and the transition timelines for the In Vitro Diagnostic Regulation (IVDR). 🔎 Key Highlights of Regulation (EU) 2024/1860: 1️⃣ EUDAMED Implementation: Clear guidelines for the European database on medical devices, ensuring enhanced traceability and transparency. 2️⃣ IVDR Transition Dates: extension of the transitional period 3️⃣All manufacturers and economic operators in the supply chain must notify supply disruptions or risks of disruption. 💡 The Notified Body GMED has written an article to explain the various paragraphs of this text and its impact 👉 https://lnkd.in/exnS3i_a 🔺 Let’s work together to ensure compliance and leverage these new guidelines to drive excellence in the medical device industry! Juliette Desvilles / Franck Martin / David HOUOT #EURegulation #EUDAMED #IVDR #MedicalDevices #Compliance #Innovation

🔍 Regulatory documentation for medical and in vitro diagnostic device manufacturers, particularly with #EUDAMED, is increasingly complex. 🚀 Join RWS Tridion for a webinar that explores how a data-driven and componentized approach to content management ensures consistency across data and content, accelerates documentation creation and review, and assures compliance of documentation submissions in relation to device registration. Gain techniques to enhance compliance and accuracy in documentation submissions. 💡 REGISTER HERE: https://buff.ly/4alsqMb Expert speakers from RWS Group: André Schlotz Jörg Schmidt #MedicalDevice #Regulatory #IVD #RegulatoryAffairs #RegulatoryCompliance #Diagnostics #MedicalDeviceRegulation #InVitroDiagnostics #IVDR

It's heartening to see that ANVISA, Brazil's health regulatory agency, has released a groundbreaking Collegiate Board Resolution updating regulations for in-vitro diagnostic (IVD) medical devices 🧪. Here are the key points: 1️⃣. Updated risk classification rules for various IVD device types. 2️⃣. New classification rules for companion diagnostics and neonatal screening devices 🧬. 3️⃣. Controlled devices without assigned values now classified as IVDs. 4️⃣. Health risk differentiation elimination for blood gas and glucose devices 🩸. 5️⃣. Permission granted for non-printed instructions for use in certain cases 📄. Why should one think that this needs to Matter? This alignment with international practices could not only streamline market entry for global companies but also ensure continued focus on public health and user safety 🛡️.

Learn about the drug and medical device approval process. This process follows well-established paths to make sure that medical products are safe and effective when they reach the public. https://lnkd.in/gnZYbT8j Clinical Trials: What Patients Need to Know https://lnkd.in/g7TiNh8f New Drug Development and Review Process https://lnkd.in/gyjYcemu

It is now official! To minimize shortages of medical products and ensure a gradual roll-out of EUDAMED, the European Commission has published Regulation (EU) 2024/1860 in the Official Journal.   This means that IVD devices that meet certain criteria can benefit from the following transition periods:   Class D - December 31, 2027 Class C - December 31, 2028 Class B and Class A (Sterile condition) - December 31, 2029 More changes can be found in the attached regulation. #IVDR #regulatoryaffairs #regulatoryglobe #MDR

🔔The European Commission has approved the proposal released on January 23, 2024.   📜 Key points:   🔹 Extended Transitional Periods: Further extensions for transitional periods, especially for high-risk in vitro diagnostic medical devices (IVDs), effectively mitigating the risk of device shortages and ensuring continuous patient care.   🔹Progressive Deployment of Eudamed Modules:  Early use of operational Eudamed modules is now supported, enhancing transparency in device tracking and ensuring effective market surveillance.     🔹Pre-Market Notification: A new requirement for manufacturers to notify authorities before ceasing supply of critical medical devices, ensuring proactive risk management in supply chain disruptions.   🔹Support for SMEs: The proposal includes measures to facilitate the transition to the new regulatory regime.   #IVDR #MDR #MedicalDevices #Eudamed #RegulatoryAffairs #MedTech #EuropeanCommission #PatientSafety

The new EUDAMED roadmap includes updates accounting for the recent amendments to the European medical device and diagnostics regulations. However, it’s still not clear when the clinical investigation and performance study module will be done. Read our analysis here: https://bit.ly/3Wi2z2z #AgencyIQ #Politico #LifeSciences #Regulation #Regulatory #EUDAMED #MedicalDevice #Diagnostics

🔬 **New Guidance Alert!** 📑 👉 **MDCG 2020-16: Classification Rules for In Vitro Diagnostic Medical Devices** 🔍 **What's Inside?** This comprehensive document provides clarity on IVD classification rules as set out under Annex VIII of the **IVDR**. It covers various scenarios and examples, making it a valuable resource for regulatory professionals and quality experts. 📌 **Key Points:** 1. **Intended Purpose:** Understand how devices are classified based on their purpose. 2. **Application of Rules:** Dive into the nitty-gritty of technology, specimen, and more. 3. **Examples Covered:** Explore real-world cases related to life-threatening diseases and infectious loads. 📢 **Why It Matters:** Staying up-to-date with IVD regulations is crucial for manufacturers, notified bodies, and anyone involved in the medical device industry. This guidance ensures compliance and patient safety. 🚀 **Share the Knowledge:** Feel free to read the document here and spread the word! Let's empower our community with accurate information. 💪 Remember, knowledge-sharing drives progress! 🌟 If you find this helpful, feel free to reshare. 🙌 #IVD #MedicalDevices #RegulatoryAffairs #QualityAssurance *Disclaimer: This post is for informational purposes only and does not constitute legal advice.*